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Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

Official Title: Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study)

Study ID: NCT00792948

Study Description

Brief Summary: This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).

Detailed Description: PRIMARY OBJECTIVES: I. To test whether the relapse-free survival after allogeneic stem cell transplantation among Philadelphia chromosome positive and/or breakpoint cluster region (BCR)/Abelson murine leukemia viral oncogene (ABL) positive acute lymphoblastic leukemia (ALL) patients given an intensive short-term chemotherapy regimen of fractionated cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (hyper-CVAD) in combination with the tyrosine kinase inhibitor dasatinib is sufficiently high to warrant further investigation. SECONDARY OBJECTIVES: I. To test whether the continuous complete remission rate for previously untreated Philadelphia chromosome positive and/or BCR/ABL positive acute lymphoblastic leukemia (ALL) patients given an intensive short-term chemotherapy regimen of hyper-CVAD in combination with the tyrosine kinase inhibitor dasatinib is sufficiently high to warrant phase III investigation. II. To investigate in a preliminary manner the relative effectiveness of minimal residual disease (MRD) detection using real-time quantitative polymerase chain reaction (PCR) for BCR/ABL versus flow cytometry to predict the outcome of patients treated by the hyper-CVAD + dasatinib regimen and/or allogeneic stem cell transplant. TERTIARY OBJECTIVES: I. To estimate the frequency and severity of toxicities of the intensive short-term chemotherapy regimen in these patients. II. To estimate the overall survival of all patients on this study. OUTLINE: INDUCTION/CONSOLIDATION THERAPY: All patients receive both of the following regimens in alternating courses: COURSES 1, 3, 5, 7 or 3, 5, 7, 9: Patients receive cyclophosphamide intravenously (IV) over 3 hours twice daily (BID) on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 30 minutes on days 4 and 11; dexamethasone IV or orally (PO) once daily (QD) on days 1-4 and 11-14; dasatinib PO QD on days 1-14; cytarabine intrathecally (IT) on day 7; methotrexate IT on day 2; and filgrastim (G-CSF) subcutaneously (SC) QD or BID. COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 24 hours on day 1; methylprednisolone IV over 30 minutes BID on days 1-3; dasatinib PO QD on days 1-14; high-dose cytarabine IV over 2 hours BID on days 2-3; leucovorin calcium IV on days 2 or 3; methotrexate IT on day 2; cytarabine IT on day 7; and G-CSF SC QD or BID. Treatment repeats every 14-21 days for 8 courses in the absence of disease progression, unacceptable toxicity, or if patient achieves complete remission (CR) or complete remission with incomplete platelet recovery (CRi). MAINTENANCE THERAPY\*: Patients receive vincristine sulfate IV over 30 minutes on day 1, prednisone PO QD on days 1-5, and dasatinib PO QD on days 1-28. Treatment repeats every month for 24 courses in the absence of disease progression or unacceptable toxicity or until the transplant is ready. INTENSIFICATION: For courses 6 and 13, patients receive cyclophosphamide IV over 3 hours BID on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 30 minutes on days 4 and 11; dexamethasone IV or PO QD on days 1-4 and 11-14; dasatinib PO QD on days 1-14; and G-CSF SC QD or BID. NOTE: \*Only if transplantation is not ready after induction/consolidation therapy or patients are not undergoing a transplant. ALLOGENEIC STEM CELL TRANSPLANTATION (FOR PATIENTS ACHIEVING CR OR CRi): CONDITIONING REGIMEN: Patients receive 1 of the following regimens: REGIMEN A: Patients receive total-body irradiation (TBI) QD on days -7 to -4 and cyclophosphamide IV on days -3 and -2. REGIMEN B: Patients receive TBI BID on days -6 to -4 and cyclophosphamide IV on days -3 and -2. REGIMEN C: Patients receive cyclophosphamide IV on days -7 and -6 and TBI QD on days -4 to -1. REGIMEN D: Patients receive cyclophosphamide IV on days -6 and -5 and TBI BID on days -3 to -1. REGIMEN E: Patients receive TBI QD on days -7 to -4 and etoposide IV on day -3. REGIMEN F: Patients receive TBI BID on days -6 to -4 and etoposide IV on day -3. ALLOGENEIC STEM CALL TRANSPLANTATION: Patients undergo allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive 1 of the following regimens: REGIMEN A: Patients receive sirolimus PO and tacrolimus IV continuously (changing to PO BID) beginning on day -3 and continuing for 6 months. REGIMEN B: Patients receive tacrolimus IV continuously (changing to PO BID) and continuing for 6 months, and methotrexate IV on days 1, 3, 6, and 11. SINGLE-AGENT THERAPY: After completion of maintenance therapy or beginning on day 100 post-transplantation, patients receive dasatinib PO QD for up to 5 years. After completion of study therapy, patients are followed every 6 months for up to 5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Banner University Medical Center - Tucson, Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States

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

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

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

University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States

AdventHealth Orlando, Orlando, Florida, United States

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

MacNeal Hospital and Cancer Center, Berwyn, Illinois, United States

Hematology and Oncology Associates, Chicago, Illinois, United States

Northwestern University, Chicago, Illinois, United States

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

Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, United States

Presence Saint Mary's Hospital, Kankakee, Illinois, United States

AMG Libertyville - Oncology, Libertyville, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

DuPage Medical Group-Ogden, Naperville, Illinois, United States

Illinois Cancer Specialists-Niles, Niles, Illinois, United States

Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Franciscan Saint Francis Health-Beech Grove, Beech Grove, Indiana, United States

Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States

Reid Health, Richmond, Indiana, United States

Siouxland Regional Cancer Center, Sioux City, Iowa, United States

Mercy Medical Center-Sioux City, Sioux City, Iowa, United States

Saint Luke's Regional Medical Center, Sioux City, Iowa, United States

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

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

HaysMed, Hays, Kansas, United States

Hutchinson Regional Medical Center, Hutchinson, Kansas, United States

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

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

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

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

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

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

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

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

University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States

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

Ascension Via Christi - Pittsburg, Pittsburg, Kansas, United States

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

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

Salina Regional Health Center, Salina, Kansas, United States

University of Kansas Health System Saint Francis Campus, Topeka, Kansas, United States

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

Associates In Womens Health, Wichita, 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

Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States

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

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

Hematology/Oncology Clinic PLLC, Baton Rouge, Louisiana, United States

Tulane University School of Medicine, New Orleans, Louisiana, United States

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

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

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

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Bronson Battle Creek, Battle Creek, Michigan, United States

Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States

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

Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, United States

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

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

Trinity Health Muskegon Hospital, Muskegon, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

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

Mayo Clinic in Rochester, Rochester, Minnesota, United States

University Health Truman Medical Center, Kansas City, Missouri, United States

The University of Kansas Cancer Center-South, Kansas City, Missouri, United States

University of Kansas Cancer Center - North, Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States

SSM Health Saint Louis University Hospital, Saint Louis, Missouri, United States

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

Billings Clinic Cancer Center, Billings, Montana, United States

Saint Vincent Healthcare, Billings, Montana, United States

Montana Cancer Consortium NCORP, 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

Saint Peter's Community Hospital, Helena, Montana, United States

Glacier Oncology PLLC, Kalispell, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Montana Cancer Specialists, Missoula, Montana, United States

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

Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States

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

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

University of Rochester, Rochester, New York, United States

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

The Jewish Hospital, Cincinnati, Ohio, United States

Case Western Reserve University, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital - Dayton, Dayton, Ohio, United States

Miami Valley Hospital, Dayton, Ohio, United States

Miami Valley Hospital North, Dayton, Ohio, United States

Dayton NCI Community Oncology Research Program, Dayton, Ohio, United States

Blanchard Valley Hospital, Findlay, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States

Wayne Hospital, Greenville, Ohio, United States

Kettering Medical Center, Kettering, Ohio, United States

Saint Rita's Medical Center, Lima, Ohio, United States

Upper Valley Medical Center, Troy, Ohio, United States

Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center, Wilmington, Ohio, United States

Greene Memorial Hospital, Xenia, Ohio, United States

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

Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States

Lewistown Hospital, Lewistown, Pennsylvania, United States

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

Mount Nittany Medical Center, State College, Pennsylvania, United States

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

Avera Cancer Institute, Sioux Falls, South Dakota, United States

Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States

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

Baylor University Medical Center, Dallas, Texas, United States

M D Anderson Cancer Center, Houston, 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

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

Cancer Care Center at Island Hospital, Anacortes, Washington, United States

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

Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States

Highline Medical Center-Main Campus, Burien, Washington, United States

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

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

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

Skagit Valley Hospital, Mount Vernon, Washington, United States

Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States

Harborview Medical Center, Seattle, Washington, United States

Minor and James Medical PLLC, Seattle, Washington, United States

Fred Hutchinson Cancer Center, Seattle, Washington, United States

Kaiser Permanente Washington, Seattle, Washington, United States

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

University of Washington Medical Center - Montlake, Seattle, Washington, United States

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

Cancer Care Northwest - Spokane South, Spokane, Washington, United States

Evergreen Hematology and Oncology PS, Spokane, Washington, United States

Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States

West Virginia University Healthcare, Morgantown, West Virginia, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Rocky Mountain Oncology, Casper, Wyoming, United States

Welch Cancer Center, Sheridan, Wyoming, United States

Contact Details

Name: Farhad Ravandi-Kashani

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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