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

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00005852
First received: June 2, 2000
Last updated: December 10, 2012
Last verified: December 2012

June 2, 2000
December 10, 2012
June 1996
July 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00005852 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow Transplant
Allogeneic Bone Marrow Transplantation for Marrow Failure States

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Biological: anti-thymocyte globulin
  • Biological: filgrastim
  • Biological: muromonab-CD3
  • Drug: cyclophosphamide
  • Drug: cyclosporine
  • Drug: methylprednisolone
  • Procedure: allogeneic bone marrow transplantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
July 2007
July 2007   (final data collection date for primary outcome measure)

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

Both
15 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00005852
MCC-11309, MCC-11309, MCC-IRB-4251, NCI-G00-1791
No
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study Chair: Steven C. Goldstein, MD H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP