Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aplastic Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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1

Participants will receive cyclophosphamide IV over 60 minutes on Days -5 to -2 with antithymocyte globulin IV over 4 hours; then, after the last does cycophosphamide, participants will receive a bone marrow transplant over 60 to 120 minutes on Day 0.

Group Type EXPERIMENTAL

Anti-thymocyte globulin

Intervention Type DRUG

Given via IV over 4 hours

Cyclophosphamide

Intervention Type DRUG

Given via IV over 60 minutes on Days -5 to -2

Bone marrow transplantation

Intervention Type PROCEDURE

Given on Day 0

2

Participants will receive cyclophosphamide IV over 60 minutes on Days -5 to -2; then, after the last does cycophosphamide, participants will receive a bone marrow transplant over 60 to 120 minutes on Day 0.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Given via IV over 60 minutes on Days -5 to -2

Bone marrow transplantation

Intervention Type PROCEDURE

Given on Day 0

Interventions

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Anti-thymocyte globulin

Given via IV over 4 hours

Intervention Type DRUG

Cyclophosphamide

Given via IV over 60 minutes on Days -5 to -2

Intervention Type DRUG

Bone marrow transplantation

Given on Day 0

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No