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

This study has been completed.

First Received on June 2, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	Fairview University Medical Center
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00005891

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:

Genetics Home Reference related topics: Fanconi anemia

MedlinePlus related topics: Anemia Aplastic Anemia Bone Marrow Transplantation

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

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

Ages Eligible for Study:	up to 54 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00005891 History of Changes
Other Study ID Numbers:	199/15099, UMN-MT-1982-10, UMN-MT-8210
Study First Received:	June 2, 2000
Last Updated:	June 23, 2005
Health Authority:	Unspecified

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
Kidney Diseases
Urologic Diseases
Renal Tubular Transport, Inborn Errors

Metabolism, Inborn Errors
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on February 12, 2012