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NCT00005892 Clinical Trial

Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia

Myelodysplastic Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005892
Other study ID # 199/15100
Secondary ID UMN-MT-1985-01UM
Status Completed
Phase N/A
First received June 2, 2000
Last updated June 23, 2005
Start date March 2000

Study information
Verified date July 2004
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of improving survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with myelodysplastic syndrome and acute leukemia related to Fanconi's anemia.

Description:

PROTOCOL OUTLINE:

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 54 Years
Eligibility - Diagnosis of Fanconi's anemia with the family history and typical phenotype including: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility

- Evidence of Fanconi's myelodysplastic syndrome Bone marrow dysplasia of all 3 marrow cell lines AND Clonal cytogenetic abnormalities demonstrable in marrow cells

- First complete remission following therapy for Fanconi's acute leukemia allowed

- Must have related histocompatible donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cyclophosphamide

Procedure:
• Allogeneic Bone Marrow Transplantation

Locations
Country Name City State
United States Fairview University Medical Center Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Fairview University Medical Center

Country where clinical trial is conducted

United States, 

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