Skip to main content
OpenTrials
Completed

NCT Number: NCT00004474

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aplastic Anemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases

Age range

Up to 59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Roswell Park Cancer Institute, Buffalo, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-thymocyte globulin

Drug

Given via IV over 4 hours

Cyclophosphamide

Drug

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

Bone Marrow Transplantation

Procedure

Given on Day 0

Primary outcomes

  1. Graft failure, graft versus host disease, and survival

    Time frame: Measured at Day 100, Month 6, and Year 1 post-transplant

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Important dates

Study start
1998
Primary completion
2007
Study completion
2007
First posted
Oct 19, 1999
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.