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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics: Anemia Bone Marrow Transplantation

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

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
Health Authority:	Unspecified

Keywords provided by Office of Rare Diseases (ORD):

Fanconi's Anemia
aplastic anemia
hematologic disorders
rare disease

Study placed in the following topic categories:

Metabolic Diseases
Fanconi's anemia
Genetic Diseases, Inborn
Hematologic Diseases
Fanconi Anemia
Rare Diseases

Anemia, Aplastic
Anemia
Cyclophosphamide
Metabolic disorder
Aplastic anemia
Bone Marrow Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
DNA Repair-Deficiency Disorders
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Anemia, Hypoplastic, Congenital
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009