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Spots Global Cancer Trial Database for Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Official Title: A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

Study ID: NCT03150693

Study Description

Brief Summary: This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Detailed Description: PRIMARY OBJECTIVES: I. To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403. II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III) SECONDARY OBJECTIVES: I. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response. II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, with censoring for transplant. III. To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS. IV. To determine the prognosis based on patients' low-density array (LDA) gene signature in terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to the C10403 backbone regimen. V. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403. TERTIARY OBJECTIVES: I. To assess both the correlation of MRD post-induction and at sequential timepoints with LDA signature. II. To evaluate the influence of MRD status (detectable vs. not and as a continuous measure) in relation to EFS both in the univariate setting as well as adjusting for other clinical features including initial white blood cell (WBC), ethnicity, gender and age at diagnosis. III. To evaluate the impact of inotuzumab ozogamicin (inotuzumab) on the kinetics of MRD during treatment with inotuzumab in patients randomized to the experimental treatment arm. IV. To perform genomic analyses to identify and evaluate the incidence and clinical significance of recurring novel fusion genes including those associated with the BCR-ABL1-like signature and to correlate with MRD status, CR rate, EFS and OS. V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population. VI. To assess the incidence of inherited genetic variants in the GR1A1, CEP72, CPA2, TPMT, NUDT15, GRIN3A, GRIK1, and other genes (which can be found using a whole genome association study \[GWAS\]), are correlated with increased rates of target toxicities including peripheral neuropathy, hepatotoxicity, pancreatitis, myelosuppression, neurotoxicity, thrombosis, and osteonecrosis, and correlate with treatment discontinuation and other clinical response parameters including complete response (CR) rate, EFS, and OS. VII. To evaluate asparaginase pharmacokinetics in adolescents and young adults, and investigate its correlation with toxicities and treatment outcomes. VIII. To investigate the effect of anti-polyethylene glycol (PEG) and anti-agouti signaling protein (ASP) antibodies (PEG-ASP) on ASP enzyme activity. IX. To measure adherence to oral 6 mercaptopurine (MP) and methotrexate in AYAs with acute lymphoblastic leukemia (ALL) and to examine sociodemographic and behavioral determinants of adherence. X. To determine the impact of adherence on risk of relapse among AYAs with ALL. OUTLINE: COURSE I (REMISSION INDUCTION THERAPY): All patients receive allopurinol orally (PO) once daily until peripheral blasts and extramedullary disease are reduced and cytarabine intrathecally (IT) over 1 minute on day 1. Patients also receive daunorubicin hydrochloride intravenously (IV) and vincristine sulfate IV on days 1, 8, 15 and 22, dexamethasone PO or IV twice daily (BID) on days 1-7 and 15-21, pegylated L-aspiraginase IV on day 4, 5, or 6, and methotrexate IT over 1 minute on days 8 and 29. Patients with central nervous system (CNS) 3 disease receive methotrexate IT over 1 minute also on days 15 and 22. All patients then undergo bone marrow aspirate and biopsy on day 29. Patients with response to remission induction therapy are randomized to 1 of 2 arms. Patients with no response are omitted from the study. ARM I: COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV on days 15, 22, 43, and 50. Patients also receive pegylated L-aspiraginase IV on days 15 and 43, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20 positive (+) patients receive rituximab IV on days 1, 8, 29, and 36. Patients then undergo bone marrow aspirate and biopsy on day 56. COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 11, 21, 31, and 41, methotrexate IV and IT on days 1, 11, 21, 31, and 41, and pegylated L-aspiraginase IV on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11. COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV on days 1, 8, and 15, and pegylated L-aspiraginase IV on day 4, 5, or 6 and day 43. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy on day 50. COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT or PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. After completion of study treatment, patients are followed up every month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth through tenth year.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

Anchorage Radiation Therapy Center, Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States

Alaska Women's Cancer Care, Anchorage, Alaska, United States

Anchorage Oncology Centre, Anchorage, Alaska, United States

Katmai Oncology Group, Anchorage, Alaska, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

Fairbanks Memorial Hospital, Fairbanks, Alaska, United States

Kingman Regional Medical Center, Kingman, Arizona, United States

Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States

PCR Oncology, Arroyo Grande, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States

Community Cancer Institute, Clovis, California, United States

University Oncology Associates, Clovis, California, United States

UC Irvine Health Cancer Center-Newport, Costa Mesa, California, United States

Kaiser Permanente Dublin, Dublin, California, United States

Kaiser Permanente-Fremont, Fremont, California, United States

Fresno Cancer Center, Fresno, California, United States

Kaiser Permanente-Fresno, Fresno, California, United States

Kaiser Permanente-Modesto, Modesto, California, United States

Kaiser Permanente Oakland-Broadway, Oakland, California, United States

Kaiser Permanente-Oakland, Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Stanford Cancer Institute Palo Alto, Palo Alto, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, United States

Kaiser Permanente- Marshall Medical Offices, Redwood City, California, United States

Kaiser Permanente-Redwood City, Redwood City, California, United States

Kaiser Permanente-Richmond, Richmond, California, United States

Rohnert Park Cancer Center, Rohnert Park, California, United States

Kaiser Permanente-Roseville, Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, United States

Kaiser Permanente Downtown Commons, Sacramento, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Kaiser Permanente-South Sacramento, Sacramento, California, United States

South Sacramento Cancer Center, Sacramento, California, United States

Kaiser Permanente - Sacramento, Sacramento, California, United States

Kaiser Permanente-San Francisco, San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, United States

Kaiser Permanente San Leandro, San Leandro, California, United States

Kaiser Permanente-San Rafael, San Rafael, California, United States

Kaiser San Rafael-Gallinas, San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States

Kaiser Permanente-Santa Rosa, Santa Rosa, California, United States

Kaiser Permanente Cancer Treatment Center, South San Francisco, California, United States

Kaiser Permanente-South San Francisco, South San Francisco, California, United States

Kaiser Permanente-Stockton, Stockton, California, United States

Kaiser Permanente Medical Center-Vacaville, Vacaville, California, United States

Kaiser Permanente-Vallejo, Vallejo, California, United States

Kaiser Permanente-Walnut Creek, Walnut Creek, California, United States

Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, United States

The Medical Center of Aurora, Aurora, Colorado, United States

Boulder Community Hospital, Boulder, Colorado, United States

Boulder Community Foothills Hospital, Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial, Centennial, Colorado, United States

Cancer Center of Colorado at Sloan's Lake, Denver, Colorado, United States

National Jewish Health-Main Campus, Denver, Colorado, United States

The Women's Imaging Center, Denver, Colorado, United States

Colorado Blood Cancer Institute, Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States

Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, United States

SCL Health Saint Joseph Hospital, Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose, Denver, Colorado, United States

Rose Medical Center, Denver, Colorado, United States

Western Surgical Care, Denver, Colorado, United States

Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, United States

Rocky Mountain Cancer Centers - Swedish, Englewood, Colorado, United States

Swedish Medical Center, Englewood, Colorado, United States

The Melanoma and Skin Cancer Institute, Englewood, Colorado, United States

National Jewish Health-Western Hematology Oncology, Golden, Colorado, United States

Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, United States

Banner North Colorado Medical Center, Greeley, Colorado, United States

Good Samaritan Medical Center, Lafayette, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States

Sky Ridge Medical Center, Lone Tree, Colorado, United States

Banner McKee Medical Center, Loveland, Colorado, United States

National Jewish Health-Northern Hematology Oncology, Thornton, Colorado, United States

Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, United States

SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Holy Cross Hospital, Fort Lauderdale, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States

Miami Cancer Institute, Miami, Florida, United States

Orlando Health Cancer Institute, Orlando, Florida, United States

Memorial Hospital West, Pembroke Pines, Florida, United States

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Augusta University Medical Center, Augusta, Georgia, United States

Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States

Pali Momi Medical Center, 'Aiea, Hawaii, United States

Queen's Cancer Center - Pearlridge, 'Aiea, Hawaii, United States

The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States

Island Urology-Hilo, Hilo, Hawaii, United States

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States

Island Urology, Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States

Queen's Medical Center, Honolulu, Hawaii, United States

Straub Clinic and Hospital, Honolulu, Hawaii, United States

University of Hawaii Cancer Center, Honolulu, Hawaii, United States

Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, United States

Kuakini Medical Center, Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States

Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States

Walter Knox Memorial Hospital, Emmett, Idaho, United States

Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States

Idaho Urologic Institute-Meridian, Meridian, Idaho, United States

Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States

Kootenai Cancer Clinic, Sandpoint, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States

Saint Anthony's Health, Alton, Illinois, United States

Loyola Center for Health at Burr Ridge, Burr Ridge, Illinois, United States

Northwestern University, Chicago, Illinois, United States

Rush University Medical Center, Chicago, Illinois, United States

University of Illinois, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, United States

Loyola Medicine Homer Glen, Homer Glen, Illinois, United States

Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States

Rush Cancer Care in Lisle, Lisle, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Marjorie Weinberg Cancer Center at Loyola-Gottlieb, Melrose Park, Illinois, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States

Saint Anthony Regional Hospital, Carroll, Iowa, United States

Blank Children's Hospital, Des Moines, Iowa, United States

Iowa Methodist Medical Center, Des Moines, Iowa, United States

Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States

Broadlawns Medical Center, Des Moines, Iowa, United States

Iowa Lutheran Hospital, Des Moines, Iowa, United States

Trinity Regional Medical Center, Fort Dodge, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

Methodist West Hospital, West Des Moines, Iowa, United States

Central Care Cancer Center - Garden City, Garden City, Kansas, United States

Central Care Cancer Center - Great Bend, Great Bend, Kansas, United States

University of Kansas Cancer Center, Kansas City, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States

Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

Wesley Medical Center, Wichita, Kansas, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Ochsner Health Center-Summa, Baton Rouge, Louisiana, United States

Medical Center of Baton Rouge, Baton Rouge, Louisiana, United States

Ochsner High Grove, Baton Rouge, Louisiana, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States

Bronson Battle Creek, Battle Creek, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States

Trinity Health Medical Center - Brighton, Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, United States

Trinity Health Medical Center - Canton, Canton, Michigan, United States

Caro Cancer Center, Caro, Michigan, United States

Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States

Hematology Oncology Consultants-Clarkston, Clarkston, Michigan, United States

Newland Medical Associates-Clarkston, Clarkston, Michigan, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Ascension Saint John Hospital, Detroit, Michigan, United States

Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, United States

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States

Genesee Hematology Oncology PC, Flint, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, United States

Academic Hematology Oncology Specialists, Grosse Pointe Woods, Michigan, United States

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States

Michigan Breast Specialists-Grosse Pointe Woods, Grosse Pointe Woods, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Ascension Borgess Cancer Center, Kalamazoo, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

University of Michigan Health - Sparrow Lansing, Lansing, Michigan, United States

Hope Cancer Clinic, Livonia, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States

Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States

Michigan Breast Specialists-Macomb Township, Macomb, Michigan, United States

Saint Mary's Oncology/Hematology Associates of Marlette, Marlette, Michigan, United States

Trinity Health Muskegon Hospital, Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital, Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores, Michigan, United States

Hope Cancer Center, Pontiac, Michigan, United States

Michigan Healthcare Professionals Pontiac, Pontiac, Michigan, United States

Newland Medical Associates-Pontiac, Pontiac, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac, Michigan, United States

Corewell Health Reed City Hospital, Reed City, Michigan, United States

Great Lakes Cancer Management Specialists-Rochester Hills, Rochester Hills, Michigan, United States

Ascension Saint Mary's Hospital, Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph, Michigan, United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph, Michigan, United States

Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, United States

Ascension Saint Joseph Hospital, Tawas City, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

Advanced Breast Care Center PLLC, Warren, Michigan, United States

Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, United States

Macomb Hematology Oncology PC, Warren, Michigan, United States

Michigan Breast Specialists-Warren, Warren, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Saint Mary's Oncology/Hematology Associates of West Branch, West Branch, Michigan, United States

University of Michigan Health - West, Wyoming, Michigan, United States

Huron Gastroenterology PC, Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States

Riverwood Healthcare Center, Aitkin, Minnesota, United States

Essentia Health Saint Joseph's Medical Center, Brainerd, Minnesota, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville, Burnsville, Minnesota, United States

Cambridge Medical Center, Cambridge, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic, Deer River, Minnesota, United States

Essentia Health Saint Mary's - Detroit Lakes Clinic, Detroit Lakes, Minnesota, United States

Essentia Health Cancer Center, Duluth, Minnesota, United States

Essentia Health Saint Mary's Medical Center, Duluth, Minnesota, United States

Miller-Dwan Hospital, Duluth, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Lake Region Healthcare Corporation-Cancer Care, Fergus Falls, Minnesota, United States

Essentia Health - Fosston, Fosston, Minnesota, United States

Unity Hospital, Fridley, Minnesota, United States

Essentia Health Hibbing Clinic, Hibbing, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center, Minneapolis, Minnesota, United States

Health Partners Inc, Minneapolis, Minnesota, United States

Monticello Cancer Center, Monticello, Minnesota, United States

New Ulm Medical Center, New Ulm, Minnesota, United States

Essentia Health - Park Rapids, Park Rapids, Minnesota, United States

Fairview Northland Medical Center, Princeton, Minnesota, United States

North Memorial Medical Health Center, Robbinsdale, Minnesota, United States

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Essentia Health Sandstone, Sandstone, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Lakeview Hospital, Stillwater, Minnesota, United States

Essentia Health Virginia Clinic, Virginia, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Rice Memorial Hospital, Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States

Fairview Lakes Medical Center, Wyoming, Minnesota, United States

Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States

Cox Cancer Center Branson, Branson, Missouri, United States

Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States

Freeman Health System, Joplin, Missouri, United States

Mercy Hospital Joplin, Joplin, Missouri, United States

Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital South, Saint Louis, Missouri, United States

Siteman Cancer Center-South County, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Mercy Hospital Washington, Washington, Missouri, United States

Community Hospital of Anaconda, Anaconda, Montana, United States

Billings Clinic Cancer Center, Billings, Montana, United States

Saint Vincent Healthcare, Billings, Montana, United States

Saint Vincent Frontier Cancer Center, Billings, Montana, United States

Bozeman Health Deaconess Hospital, Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States

Benefis Sletten Cancer Institute, Great Falls, Montana, United States

Great Falls Clinic, Great Falls, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States

Community Medical Center, Missoula, Montana, United States

Nebraska Medicine-Village Pointe, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Carson Tahoe Regional Medical Center, Carson City, Nevada, United States

Cancer and Blood Specialists-Henderson, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson, Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, United States

GenesisCare USA - Henderson, Henderson, Nevada, United States

Las Vegas Urology - Green Valley, Henderson, Nevada, United States

Las Vegas Urology - Pebble, Henderson, Nevada, United States

Urology Specialists of Nevada - Green Valley, Henderson, Nevada, United States

Las Vegas Urology - Pecos, Las Vegas, Nevada, United States

Desert West Surgery, Las Vegas, Nevada, United States

OptumCare Cancer Care at Charleston, Las Vegas, Nevada, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

Hope Cancer Care of Nevada, Las Vegas, Nevada, United States

Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States

Urology Specialists of Nevada - Central, Las Vegas, Nevada, United States

GenesisCare USA - Las Vegas, Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States

Las Vegas Prostate Cancer Center, Las Vegas, Nevada, United States

Las Vegas Urology - Sunset, Las Vegas, Nevada, United States

Urology Specialists of Nevada - Southwest, Las Vegas, Nevada, United States

Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, United States

Ann M Wierman MD LTD, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States

GenesisCare USA - Vegas Tenaya, Las Vegas, Nevada, United States

Las Vegas Urology - Cathedral Rock, Las Vegas, Nevada, United States

Las Vegas Urology - Smoke Ranch, Las Vegas, Nevada, United States

OptumCare Cancer Care at MountainView, Las Vegas, Nevada, United States

Urology Specialists of Nevada - Northwest, Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, United States

Summerlin Hospital Medical Center, Las Vegas, Nevada, United States

Las Vegas Cancer Center-Medical Center, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

GenesisCare USA - Fort Apache, Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States

University Cancer Center, Las Vegas, Nevada, United States

Hope Cancer Care of Nevada-Pahrump, Pahrump, Nevada, United States

Renown Regional Medical Center, Reno, Nevada, United States

Saint Mary's Regional Medical Center, Reno, Nevada, United States

Radiation Oncology Associates, Reno, Nevada, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States

North Shore University Hospital, Manhasset, New York, United States

Long Island Jewish Medical Center, New Hyde Park, New York, United States

Mount Sinai Hospital, New York, New York, United States

NYP/Weill Cornell Medical Center, New York, New York, United States

University of Rochester, Rochester, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

Upstate Cancer Center at Verona, Verona, New York, United States

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

East Carolina University, Greenville, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Essentia Health Cancer Center-South University Clinic, Fargo, North Dakota, United States

Essentia Health - Jamestown Clinic, Jamestown, North Dakota, United States

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States

Case Western Reserve University, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States

Saint Alphonsus Medical Center-Baker City, Baker City, Oregon, United States

Saint Charles Health System, Bend, Oregon, United States

Clackamas Radiation Oncology Center, Clackamas, Oregon, United States

Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States

Bay Area Hospital, Coos Bay, Oregon, United States

Providence Newberg Medical Center, Newberg, Oregon, United States

Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, Portland, Oregon, United States

Oregon Health and Science University, Portland, Oregon, United States

Saint Charles Health System-Redmond, Redmond, Oregon, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States

Pocono Medical Center, East Stroudsburg, Pennsylvania, United States

Lehigh Valley Hospital-Hazleton, Hazleton, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Miriam Hospital, Providence, Rhode Island, United States

Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States

Prisma Health Cancer Institute - Laurens, Clinton, South Carolina, United States

Prisma Health Richland Hospital, Columbia, South Carolina, United States

Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States

Saint Francis Hospital, Greenville, South Carolina, United States

BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States

Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States

Saint Francis Cancer Center, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States

Houston Methodist Hospital, Houston, Texas, United States

Covenant Medical Center-Lakeside, Lubbock, Texas, United States

American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, United States

Sandra L Maxwell Cancer Center, Cedar City, Utah, United States

Logan Regional Hospital, Logan, Utah, United States

Intermountain Medical Center, Murray, Utah, United States

McKay-Dee Hospital Center, Ogden, Utah, United States

Utah Valley Regional Medical Center, Provo, Utah, United States

Riverton Hospital, Riverton, Utah, United States

Saint George Regional Medical Center, Saint George, Utah, United States

Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, United States

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

LDS Hospital, Salt Lake City, Utah, United States

Inova Schar Cancer Institute, Fairfax, Virginia, United States

Inova Fairfax Hospital, Falls Church, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States

Overlake Medical Center, Bellevue, Washington, United States

PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States

Providence Regional Cancer System-Centralia, Centralia, Washington, United States

Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States

Providence Regional Cancer Partnership, Everett, Washington, United States

Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States

Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States

Providence Regional Cancer System-Lacey, Lacey, Washington, United States

PeaceHealth Saint John Medical Center, Longview, Washington, United States

Jefferson Healthcare, Port Townsend, Washington, United States

Valley Medical Center, Renton, Washington, United States

Pacific Gynecology Specialists, Seattle, Washington, United States

Swedish Medical Center-Ballard Campus, Seattle, Washington, United States

Kaiser Permanente Washington, Seattle, Washington, United States

Swedish Medical Center-Cherry Hill, Seattle, Washington, United States

Swedish Medical Center-First Hill, Seattle, Washington, United States

PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States

Providence Regional Cancer System-Shelton, Shelton, Washington, United States

PeaceHealth Southwest Medical Center, Vancouver, Washington, United States

Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States

Providence Regional Cancer System-Yelm, Yelm, Washington, United States

Duluth Clinic Ashland, Ashland, Wisconsin, United States

Northwest Wisconsin Cancer Center, Ashland, Wisconsin, United States

Essentia Health-Hayward Clinic, Hayward, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States

Essentia Health-Spooner Clinic, Spooner, Wisconsin, United States

Essentia Health Saint Mary's Hospital - Superior, Superior, Wisconsin, United States

Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, United States

Billings Clinic-Cody, Cody, Wyoming, United States

Welch Cancer Center, Sheridan, Wyoming, United States

Tom Baker Cancer Centre, Calgary, Alberta, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

QEII Health Sciences Centre/Nova Scotia Health Authority, Halifax, Nova Scotia, Canada

Ottawa Hospital and Cancer Center-General Campus, Ottawa, Ontario, Canada

Jewish General Hospital, Montreal, Quebec, Canada

Contact Details

Name: daniel_deangelo@dfci.harvard.edu J. DeAngelo, MD, PhD

Affiliation: Dana-Farber Cancer Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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