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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aplastic Anemia

Intervention: Anti-thymocyte globulin (Drug); Cyclophosphamide (Drug); Bone marrow transplantation (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Roswell Park Cancer Institute

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Primary outcome: Graft failure, graft versus host disease, and survival

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.

Eligibility

Minimum age: N/A. Maximum age: 59 Years. Gender(s): 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

Locations and Contacts

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

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

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

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

Additional Information

Starting date: September 1998
Last updated: October 1, 2008

Page last updated: August 20, 2015

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