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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00005852
Date of registration: 02/06/2000
Prospective Registration: No
Primary sponsor: H. Lee Moffitt Cancer Center and Research Institute
Public title: Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow Transplant
Scientific title: Allogeneic Bone Marrow Transplantation for Marrow Failure States
Date of first enrolment: June 1996
Target sample size:
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00005852
Study type:  Interventional
Study design:  Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Contacts
Name:     Steven C. Goldstein, MD
Address: 
Telephone:
Email:
Affiliation:  H. Lee Moffitt Cancer Center and Research Institute
Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: 55 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Intervention(s)
Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: muromonab-CD3
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methylprednisolone
Procedure: allogeneic bone marrow transplantation
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
MCC-11309
MCC-IRB-4251
NCI-G00-1791
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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