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

This study has been completed.

First Received: June 2, 2000 Last Updated: 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:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: 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

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

Keywords provided by Office of Rare Diseases (ORD):

Fanconi's Anemia
aplastic anemia
hematologic disorders
rare disease

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Hematologic Diseases
Fanconi Anemia
DNA Repair-Deficiency Disorders
Physiological Effects of Drugs
Anemia
Cyclophosphamide
Immunosuppressive Agents

Pharmacologic Actions
Anemia, Hypoplastic, Congenital
Genetic Diseases, Inborn
Therapeutic Uses
Myeloablative Agonists
Anemia, Aplastic
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Bone Marrow Diseases
Alkylating Agents

ClinicalTrials.gov processed this record on November 30, 2009