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Spots Global Cancer Trial Database for Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

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Trial Identification

Brief Title: Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

Official Title: A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults

Study ID: NCT04530565

Study Description

Brief Summary: This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

Detailed Description: PRIMARY OBJECTIVE: I. To compare the overall survival (OS) following induction with steroids + TKI + blinatumomab versus induction with steroids + TKI + chemotherapy. SECONDARY OBJECTIVES: I. To compare the rate of minimal residual disease (MRD) negativity for patients treated with chemotherapy versus (vs) blinatumomab at the end of first induction (week 15). II. To evaluate the rate of the MRD negativity by treatment arm for those patients MRD positive after the first induction and administered of second induction. III. To compare event free survival (EFS) for patients initially randomized for chemotherapy vs blinatumomab. IV. To assess the toxicities of blinatumomab + TKI vs. TKI + chemotherapy in this patient population. V. To assess the toxicities of the chemotherapy regimen in this patient population. VI. To describe the outcome of patients who proceed to allogeneic stem cell transplant after treatment with blinatumomab + TKI only. OUTLINE: ARM A (PRE-INDUCTION): Patients receive prednisone orally (PO) once daily (QD) on days 1-21 and ponatinib hydrochloride (ponatinib) PO QD or dasatinib PO QD on days 1-21 based on investigator's choice. Patients are randomized to 1 of 2 arms (Arm B or C). Patients undergo bone marrow aspiration with biopsy, lumbar punctures, echocardiogram (ECHO), and multigated acquisition (MUGA) scans as indicated by investigator. ARM B (INDUCTION THERAPY): CYCLE 1: Patients receive cyclophosphamide intravenously (IV) twice daily (BID) on days 1-3, dexamethasone PO or IV on days 1-4 and 11-14, cytarabine intrathecally (IT) on day 1, doxorubicin hydrochloride (doxorubicin) IV on day 4, vincristine sulfate (vincristine) IV on days 4 and 11, and methotrexate IT on day 8. Patients also receive Mesna 600mg/m\^2 IV as a 'chemoprotectant' via continuous infusion on days 1-3, (beginning 1 hour prior to cyclophosphamide and completed by 12 hours after the last dose of cyclophosphamide). CYCLE 2 (AGE 18-70): Starting in cycle 2, fit patients aged 18-70 receive dasatinib 70mg/day PO or ponatinib 30mg/day PO on days 1-21, methotrexate IV over 24 hours and IT on day 1, and cytarabine IV over 2 hours on days 2-3 of each cycle. On day 22 of cycle 2 or later, as soon as the absolute neutrophil count (ANC) is greater than 1000 cells/ul and platelets are greater than 50,000 cells/ul, patients receive hyper cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) for 2 additional cycles. CYCLE 2 (AGE \> 70 or unfit \< 70): Starting in cycle 2, patients age \> 70 or younger unfit patients for Hyper-CVAD receive ponatinib PO QD or dasatinib PO QD on days 1-21 of each cycle. Patients also receive methotrexate IV over 24 hours and IT on day 1, and cytarabine IV over 2 hours on days 2-3 of each cycle. Cycle 1 and 2 regimens are each repeated once starting on day 22 of cycle 2, or later, but as soon as the ANC is greater than 1000 cells/ul and platelets are greater than 50,000 cells/ul. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve remission (significant reduction in the amount of leukemia in bone marrow and blood/MRD negative) after 4 cycles may receive alternative treatment, either consolidation with two cycles of Hyper-CVAD followed by TKI maintenance therapy or undergo allogeneic stem cell transplantation followed by maintenance therapy. Patients who do not achieve a remission (MRD positive) are assigned to Arm D. Patients who experience un-resolving renal failure or life-threatening infection which may require a treatment delay of 21 days cross-over to Arm C to receive the prescribed course of blinatumomab. ARM C (INDUCTION THERAPY): CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 28 or 29. CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. ARM D (RE-INDUCTION): Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C. ARM E (RE-INDUCTION): Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm. Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care. Patients are followed up for 10 years from the date of registration.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_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

Mercy Hospital Fort Smith, Fort Smith, Arkansas, 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

City of Hope Comprehensive Cancer Center, Duarte, California, United States

UC San Diego Moores Cancer Center, La Jolla, California, United States

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

Yale University, New Haven, Connecticut, 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

Hawaii Cancer Care Inc - Waterfront Plaza, 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

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

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

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

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

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

Saint Luke's Cancer Institute - Nampa, Nampa, 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

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

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

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

Mary Greeley Medical Center, Ames, Iowa, United States

McFarland Clinic - Ames, Ames, Iowa, United States

McFarland Clinic - Boone, Boone, Iowa, United States

McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson, Jefferson, Iowa, United States

McFarland Clinic - Marshalltown, Marshalltown, 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

University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States

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

The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States

LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

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

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

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

Henry Ford Cancer Institute-Downriver, Brownstown, Michigan, United States

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

Trinity Health Medical Center - Canton, Canton, 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

Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States

Henry Ford Medical Center-Fairlane, Dearborn, Michigan, United States

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

Henry Ford Hospital, Detroit, 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

Allegiance Health, Jackson, Michigan, United States

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

Henry Ford Medical Center-Columbus, Novi, Michigan, United States

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

Henry Ford Macomb Health Center - Shelby Township, Shelby, Michigan, United States

Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States

Huron Gastroenterology PC, Ypsilanti, Michigan, United States

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

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, United States

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

Central Care Cancer Center - Bolivar, Bolivar, 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

Research Medical Center, Kansas City, 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

Siteman Cancer Center at Christian Hospital, 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

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

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

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

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

University of Rochester, Rochester, New York, United States

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

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

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

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

MetroHealth Medical Center, 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 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

Providence Willamette Falls Medical Center, Oregon City, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, 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

Geisinger Medical Center, Danville, Pennsylvania, United States

Pocono Medical Center, East Stroudsburg, 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

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States

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

Medical University of South Carolina, Charleston, South Carolina, United States

Prisma Health Cancer Institute - Easley, Easley, 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

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

Vanderbilt-Ingram Cancer Center Cool Springs, Franklin, Tennessee, United States

Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States

Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

Houston Methodist Hospital, Houston, Texas, United States

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

University of Vermont Medical Center, Burlington, Vermont, United States

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

Providence Regional Cancer System-Aberdeen, Aberdeen, 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

Pacific Gynecology Specialists, Seattle, Washington, United States

Swedish Medical Center-Ballard Campus, 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

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

Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States

Gundersen Lutheran Medical Center, La Crosse, 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

Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States

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

Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States

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

Shaare Zedek Medical Center, Jerusalem, , Israel

San Juan City Hospital, San Juan, , Puerto Rico

Contact Details

Name: Yishai Ofran

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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