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

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Brief Title

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

Official Title

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

Brief 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.

Detailed 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Graft failure, graft versus host disease, and survival

Condition

Aplastic Anemia

Intervention

Anti-thymocyte globulin

Study Arms / Comparison Groups

 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

224

Start Date

September 1998

Completion Date

August 2007

Primary Completion Date

August 2007

Eligibility 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

Gender

All

Ages

N/A - 59 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00004474

Organization ID

199/14004

Secondary IDs

RPCI-RP-9804

Study Sponsor

Roswell Park Cancer Institute

Study Sponsor

, ,

Verification Date

October 2008