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Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia - Article


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Anemia

General anemia 



Clinical Trial: Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia

This study is no longer recruiting patients.

Sponsored by: Roswell Park Cancer Institute
Information provided by: Office of Rare Diseases (ORD)

Purpose

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.

Condition Treatment or Intervention Phase
Aplastic Anemia
 Drug: anti-thymocyte globulin
 Drug: cyclophosphamide
 Procedure: Bone Marrow Transplantation
Phase III

MedlinePlus related topics:  Anemia

Study Type: Interventional
Study Design: Treatment, Randomized

Further Study Details: 

Expected Total Enrollment:  224

Study start: September 1998

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.

Eligibility

Ages Eligible for Study:  up to  59 Years,  Genders Eligible for Study:  Both

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

Location Information


New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

      Midwest Children's Cancer Center, Milwaukee,  Wisconsin,  53226,  United States

Study chairs or principal investigators

Philip L. McCarthy, Jr.,  Study Chair,  Roswell Park Cancer Institute   

More Information

Study ID Numbers:  199/14004; RPCI-RP-9804; NCI-G98-1491; IBMTR-1
Record last reviewed:  August 2002
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004474
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 24, 2014



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