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NCT00005891 Clinical Trial

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

Fanconi's Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005891
Other study ID # 199/15099
Secondary ID UMN-MT-1982-10UM
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 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.

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.

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 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

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, 

See also
  Status Clinical Trial Phase
Completed NCT03609827 - Study of Melphalan Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients
Active, not recruiting NCT00005896 - Phase I Pilot Study of CD34 Enriched, Fanconi's Anemia Complementation Group C Gene Transduced Autologous Peripheral Blood Stem Cell Transplantation in Patients With Fanconi's Anemia Phase 1
Completed NCT00005892 - Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia N/A
Completed NCT00001749 - Medical Treatment for Diamond Blackfan Anemia Phase 2
Completed NCT03609814 - Study of Clofarabine and Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation (HCT)
Completed NCT00004378 - Stem Cell Transplantation (SCT) for Genetic Diseases N/A
Completed NCT00005898 - Phase I/II Study of Total Body Irradiation, Cyclophosphamide, and Fludarabine Followed by Alternate Donor Hematopoietic Cell Transplantation in Patients With Fanconi's Anemia Phase 1/Phase 2
Completed NCT00001399 - Gene Therapy for the Treatment of Fanconi's Anemia Type C Phase 1
Completed NCT00004787 - Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes Phase 2
Active, not recruiting NCT00006127 - Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia Phase 1