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

Primary Purpose

Graft Versus Host Disease, Aplastic Anemia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
cyclophosphamide
cyclosporine
methylprednisolone
Allogeneic Bone Marrow Transplantation
Sponsored by
Northwestern Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring aplastic anemia, disease-related problem/condition, graft versus host disease, hematologic disorders, rare disease

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
June 23, 2005
Sponsor
Northwestern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00017654
Brief Title
Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern Memorial Hospital

4. Oversight

5. Study Description

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.
Detailed Description
PROTOCOL OUTLINE: Bone marrow and peripheral blood stem cells (PBSC) are harvested from a HLA identical or 1 antigen mismatched related donor. PBSC are selected for CD34+ cells and T cells are depleted. Patients receive cyclophosphamide IV over 2 hours on days -6 to -3 and anti-thymocyte globulin IV with methylprednisolone IV over 10-12 hours on days -5 to -3. T-cell depleted PBSC and bone marrow are infused on day 0. Patients receive cyclosporine IV over 12-24 hours on days -1 to 120 followed by a taper and methylprednisolone IV on days 7-64 for graft-versus-host disease prophylaxis. Patients are followed every 30 days for 1 year, every 60 days for 2 years, and then as needed for a minimum of 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Aplastic Anemia
Keywords
aplastic anemia, disease-related problem/condition, graft versus host disease, hematologic disorders, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
3 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Procedure
Intervention Name(s)
Allogeneic Bone Marrow Transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard K. Burt
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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