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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Farhad Ravandi-Kashani
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR