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

NCT00017654 | Unknown

• 3 other identifiers: 199/14983NU-96AA1TNU-96H
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: I. Determine the effect of supplementation with donor T-cell depleted, CD34+ peripheral blood stem cells on durable engraftment and incidence of graft-versus-host disease in patients with aplastic anemia undergoing allogeneic bone marrow transplantation.

Conditions

Graft Versus Host Disease; Aplastic Anemia

Keywords

aplastic anemia; disease-related problem/condition; graft versus host disease; hematologic disorders; rare disease

Interventions

anti-thymocyte globulin DRUG

cyclophosphamide DRUG

cyclosporine DRUG

methylprednisolone DRUG

Allogeneic Bone Marrow Transplantation PROCEDURE

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern Memorial Hospital: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Anemia, Aplastic; Hematologic Diseases; Rare Diseases

Interventions

Antilymphocyte Serum; Cyclophosphamide; Cyclosporine; Methylprednisolone

Condition Hierarchy (Ancestors)

Immune System Diseases; Anemia; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Richard K. Burt

  Northwestern Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: June 6, 2001
• Study Start: April 1, 2001
• Last Updated: June 24, 2005

Record last verified: 2003-10

Locations

US (1)