Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00017654
• Date of registration: 06/06/2001
• Prospective Registration: No
• Primary sponsor: Northwestern Memorial Hospital
• Public title: Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia
• Date of first enrolment: April 2001
• Target sample size: 3
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00017654
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Richard K. Burt
• Affiliation: Northwestern Memorial Hospital

Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

- Diagnosis of life-threatening or transfusion-dependent marrow or immune-mediated
failure involving one or more hematopoietic cell lines evidenced by one or more of
the following: Granulocyte count less than 500/mm3 Platelet count less than
20,000/mm3 Absolute reticulocyte count less than 60,000/mm3

- Immune-mediated anemia and/or thrombocytopenia must have failed corticosteroids and
cyclosporine

- Paroxysmal nocturnal hemoglobinuria with progressive marrow failure allowed

- Either congenital or acquired severe granulocytopenia with a history of life
threatening infections No diagnosis of Fanconi's anemia

- HLA identical or 1 antigen mismatched related donor meeting the following criteria:
No prior or concurrent malignancy except localized basal cell or squamous cell skin
cancer (malignancies judged to be cured by local surgery, such as head and neck
cancer or stage I breast cancer, considered on an individual basis) Negative
pregnancy test

--Patient Characteristics--

- Hepatic: Hepatitis B surface antigen negative Bilirubin no greater than 2.0 mg/dL
Transaminases no greater than 2 times upper limit of normal (in the absence of
Gilbert's disease)

- Renal: Creatinine no greater than 2.0 mg/dL

- Cardiovascular: No history of coronary artery disease LVEF at least 40% by MUGA

- Pulmonary: FEV1 at least 50% predicted FVC at least 50% predicted DLCO at least 50%
predicted

- Other: No uncontrolled diabetes mellitus No other illness that would preclude
aggressive chemotherapy No prior or concurrent malignancy except localized basal cell
or squamous cell skin cancer (malignancies judged to be cured by local surgery, such
as head and neck cancer or stage I breast cancer, considered on an individual basis)
No psychiatric illness or mental deficiency that would preclude study Not pregnant or
nursing Fertile patients must use effective contraception HIV negative



Age minimum: 15 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Aplastic Anemia

Graft Versus Host Disease

Intervention(s)

Drug: cyclophosphamide

Drug: cyclosporine

Procedure: Allogeneic Bone Marrow Transplantation

Drug: methylprednisolone

Drug: anti-thymocyte globulin

Secondary ID(s)

NU-96H

NU-96AA1T

199/14983

Source(s) of Monetary Support

Please refer to primary and secondary sponsors