Overview
Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
Status:
Completed
Completed
Trial end date:
2009-07-01
2009-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research InstituteCollaborator:
National Cancer Institute (NCI)Treatments:
Cyclophosphamide
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed diagnosis of one of the following:
- Acute lymphocytic leukemia (ALL):
- Complete remission (CR) 1 - high risk defined as overt CNS involvement or
poor cytogenetics (additions, deletions, translocations, or multiple
abnormalities)
- CR2
- Induction failures
- Relapse - patients with at least 10% marrow blasts undergo at least one
reinduction attempt
- Acute myelogenous leukemia (AML):
- CR1 - high risk defined as poor cytogenetics (deletions, additions, multiple
abnormalities)
- CR2
- Induction failures
- Relapse - patients with at least 10% marrow blasts undergo at least one
reinduction attempt
- Chronic myelogenous leukemia (CML):
- Chronic phase (CP) 1
- Accelerated phase/CP2 - patients in blast phase must undergo treatment and
achieve a second chronic phase prior to transplant
- Chronic lymphocytic leukemia (CLL):
- Relapse - any stage; must have received no more than 3 prior regimens
- Multiple myeloma:
- At diagnosis - primary refractory
- Relapse (no more than 2) - sensitive disease
- Plasma cell leukemia
- Inability to achieve a complete remission after autologous transplant (no
older than 40)
- Myelodysplasia - all subtypes
- Myeloproliferative disorders - patients with poor response to medical therapy or
cytogenetic abnormalities
- Severe aplastic anemia (SAA):
- Very SAA - at diagnosis
- SAA - induction therapy
- Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch
PATIENT CHARACTERISTICS:
Age:
- 15 to 50
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 3 times normal
- PT/PTT normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- Left ventricular ejection fraction at least 45%
- No myocardial infarction within past 6 months
- No uncontrolled arrhythmias
Pulmonary:
- FEV1 at least 50%
- DLCO at least 50% predicted
Other:
- No active serious infection
- HIV negative
- Not pregnant or nursing
- No uncontrolled diabetes mellitus or thyroid disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified