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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

Multiple Myeloma and Plasma Cell Neoplasm

Leukemia

Chronic Myeloproliferative Disorders

Graft Versus Host Disease

Myelodysplastic Syndromes

Lymphoma

Intervention(s)

Procedure: allogeneic bone marrow transplantation

Biological: anti-thymocyte globulin

Biological: filgrastim

Drug: cyclophosphamide

Drug: cyclosporine

Biological: muromonab-CD3

Drug: methylprednisolone

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

MCC-IRB-4251

NCI-G00-1791

MCC-11309

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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