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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004474
Other study ID # 199/14004
Secondary ID RPCI-RP-9804NCI-
Status Completed
Phase Phase 3
First received October 18, 1999
Last updated March 9, 2018
Start date September 1998
Est. completion date August 2007

Study information

Verified date October 2008
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

I. Compare outcome, including graft failure, graft versus host disease, and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.


Description:

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte globulin IV over 4 hours.

All patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last dose of cyclophosphamide.

Patients are followed at day 100, at 6 months, and at 1 year posttransplant.


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender All
Age group N/A to 59 Years
Eligibility PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Severe aplastic anemia with the following criteria:

Hypocellular bone marrow with cellularity less than 20%

At least 2 of the following hematologic abnormalities:

- Neutrophil count no greater than 500/mm3

- Platelet count no greater than 20,000/mm3

- Reticulocyte count no greater than 50,000/mm3

HLA-identical sibling donor available

No clonal cytogenetic abnormalities, paroxysmal nocturnal hemoglobinuria, or myelodysplastic syndrome within 3 months of diagnosis of aplastic anemia

No congenital or constitutional aplastic anemia or Fanconi anemia

--Patient Characteristics--

Hepatic: Bilirubin less than 3 times upper limit of normal (ULN)

Renal: Creatinine less than 2 times ULN

Cardiovascular: Normal cardiac function

Other:

- No uncontrolled infection

- No severe concurrent disease

- HIV negative

- Fertile patients must use effective contraception

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Anti-thymocyte globulin
Given via IV over 4 hours
Cyclophosphamide
Given via IV over 60 minutes on Days -5 to -2
Procedure:
Bone marrow transplantation
Given on Day 0

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Midwest Children's Cancer Center Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Graft failure, graft versus host disease, and survival Measured at Day 100, Month 6, and Year 1 post-transplant
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