Allogeneic Bone Marrow Transplantation for Marrow Failure States
15 Years
55 Years
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Trial Information
Allogeneic Bone Marrow Transplantation for Marrow Failure States
OBJECTIVES: I. Determine the graft failure rate and overall survival of patients with severe
aplastic anemia after receiving an allogeneic bone marrow transplant. II. Determine the
efficacy of high dose cyclophosphamide and antithymocyte globulin as conditioning regimen
for a second bone marrow transplant in patients who reject their first graft. III. Determine
the efficacy of methylprednisolone and anti-CD3 monoclonal antibody as a conditioning
regimen for a second bone marrow transplant in patients who reject their first graft and are
poor candidates for cyclophosphamide and antithymocyte globulin.
OUTLINE: Patients with graft failure with the following organ function and performance
status are assigned to arm I: Performance status: Karnofsky 60-100% Pulmonary: FEV1 and DLCO
at least 50% Cardiac: Left ventricular ejection fraction at least 45% Hepatic: None to mild
venoocclusive disease Patients with graft failure with the following organ function and
performance status are assigned to arm II: Performance status: Karnofsky 20-50% Pulmonary:
FEV1 or DLCO less than 50% Cardiac: Left ventricular ejection fraction less than 45%
Hepatic: Moderate to severe venoocclusive disease Patients with aplastic anemia are assigned
to arm I. Arm I: Patients receive cyclophosphamide IV over 1 hour on days -5 to -2,
antithymocyte globulin IV over 8 hours on days -5 to -3, and bone marrow transplant on day
0. Arm II: Patients receive methylprednisolone IV twice a day on days -5 to 62; monoclonal
antibody OKT3 IV on days -1 to 24; bone marrow transplant on day 0; oral cyclosporine twice
a day starting day 20; and filgrastim (G-CSF) subcutaneously once a day starting day -5
until blood counts recover. Patients are followed once a week for 3 months and then monthly
for one year.
PROJECTED ACCRUAL: A total of 40 patients (20 with aplastic anemia and 20 with graft
failure) will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Steven C. Goldstein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
MCC-11309
NCT ID:
NCT00005852
Start Date:
June 1996
Completion Date:
July 2007
Related Keywords:
- Chronic Myeloproliferative Disorders
- Graft Versus Host Disease
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- recurrent childhood acute lymphoblastic leukemia
- recurrent adult Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- relapsing chronic myelogenous leukemia
- refractory chronic lymphocytic leukemia
- primary myelofibrosis
- childhood acute promyelocytic leukemia (M3)
- refractory hairy cell leukemia
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- graft versus host disease
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- childhood myelodysplastic syndromes
- Neoplasms
- Graft vs Host Disease
- Leukemia
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
Name | Location |
|---|
