Phase II Study of IV Busulfan Combined With 12 cGy of Fractionated Total Body Irradiation (FTBI) and Etoposide (VP-16) as a Preparative Regimen for Allogeneic Bone Marrow Transplantation for Patients With Advanced Hematological Malignancies

99041

RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.

2000-02-29

2010-04-12

2024-12-30

Active (not recruiting)

Early phase I

30

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute myeloid leukemia (AML) * Failed remission induction therapy or in relapse beyond second remission * In first remission with poor risk cytogenetics (e.g., 11q abnormalities, -7, -5, complex abnormalities \[i.e., \> 3 abnormalities, 6;9 translocation and 3q abnormalities del (7q), del (5q), complex abnormalities ≥ abnormalities, 9q, 20q, 21q, 17q, t(9;21)\]) * Acute lymphoblastic leukemia (ALL) * Failed remission induction therapy or in relapse beyond second remission * Blastic phase chronic myelogenous leukemia * Refractory anemia with excess blasts * Refractory anemia with excess blasts in transformation * HLA -A, -B, -C, -DR identical sibling donor match available * No relapse after prior bone marrow transplantation PATIENT CHARACTERISTICS: * Cardiac ejection fraction ≥ 50% * Serum creatinine ≤ 1.2 times upper limit of normal (ULN) or creatinine clearance \> 80 mL/min * Bilirubin ≤ 1.5 times ULN * AST and ALT \< 5 times ULN * FEV_1 ≥ 50% of predicted normal * DLCO ≥ 50% of predicted normal * No psychological or medical condition that would preclude allogeneic transplantation (in the opinion of the treating physician) * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 28 days since prior induction or reinduction therapy * Prior etoposide and busulfan allowed * No prior radiation therapy that would exclude total-body irradiation

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2024-02-20