Overview

Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow Transplant

Status:
Terminated
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Bone marrow from donors may be able to treat patients with severe aplastic anemia and patients whose bodies have rejected previous bone marrow transplantation. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have severe aplastic anemia or whose bodies have rejected previous bone marrow transplant.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antilymphocyte Serum
Cyclophosphamide
Cyclosporine
Cyclosporins
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Muromonab-CD3
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed aplastic anemia Must have related donor
with a genotypic 6 out of 6 HLA A, B, and DR match OR Bone marrow transplant failure Must
have related donor with at least a 5 out of 6 HLA match OR Must have an unrelated donor
with at least a 5 out of 6 HLA match

PATIENT CHARACTERISTICS: Age: 15 to 55 Performance status: Aplastic anemia patients:
Karnofsky 80-100% Graft failure patients: Karnofsky 20-100% Life expectancy: Not specified
Hematopoietic: See Disease Characteristics Hepatic: Aplastic anemia patients: Bilirubin no
greater than 2.0 mg/dL SGOT/SGPT no greater than 3 times normal PT/PTT normal (except when
aplastic anemia secondary to viral hepatitis) Graft failure patients: Mild to severe
venoocclusive disease allowed Renal: Aplastic anemia patients: Creatinine no greater than
2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: Aplastic anemia patients:
Left ventricular ejection fraction at least 45% by MUGA or echocardiography No myocardial
infarction within the past 6 months No uncontrolled arrhythmias Pulmonary: Aplastic anemia
patients: FEV1 and DLCO at least 50% predicted Other: Aplastic anemia patients: No
uncontrolled diabetes mellitus or thyroid disease No active serious infections HIV negative
Not pregnant or nursing Negative pregnancy test No psychosocial problem that would preclude
study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not
specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified