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Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Fanconi's Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005891
First Posted: June 5, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVES:

I. Determine the effectiveness of moderate dose cyclophosphamide and total lymphoid radiotherapy in terms of improving the survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with Fanconi's aplastic anemia.


Condition Intervention
Fanconi's Anemia Drug: cyclophosphamide Procedure: Allogeneic Bone Marrow Transplantation

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date: March 2000
Detailed Description:

PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 2 hours on day -6 through -3 and total lymphoid radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0.

Patients are followed for at least 100 days.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 54 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Diagnosis of severe aplastic anemia with the typical phenotype of Fanconi's anemia: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility
  • Family history of Fanconi's anemia
  • Histocompatible related donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005891


Locations
United States, Minnesota
Fairview University Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Fairview University Medical Center
Investigators
Study Chair: Daniel J. Weisdorf Fairview University Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00005891     History of Changes
Other Study ID Numbers: 199/15099
UMN-MT-1982-10
UMN-MT-8210
First Submitted: June 2, 2000
First Posted: June 5, 2000
Last Update Posted: December 9, 2005
Last Verified: July 2004

Keywords provided by Office of Rare Diseases (ORD):
Fanconi's Anemia
aplastic anemia
hematologic disorders
rare disease

Additional relevant MeSH terms:
Anemia
Fanconi Anemia
Fanconi Syndrome
Hematologic Diseases
Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Bone Marrow Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists