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

This study has been completed.
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00005892
First received: June 2, 2000
Last updated: June 23, 2005
Last verified: July 2004
History of Changes
  Purpose

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.


Condition Intervention
Fanconi's Anemia
Myelodysplastic Syndromes
Leukemia, Nonlymphocytic, Acute
Leukemia, Lymphocytic, Acute
 Drug: cyclophosphamide
Procedure: Allogeneic Bone Marrow Transplantation

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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

  Eligibility

Ages Eligible for Study:   up to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005892

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: NCT00005892     History of Changes
Other Study ID Numbers: 199/15100, UMN-MT-1985-01, UMN-MT-8501
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
acute leukemia
acute lymphocytic leukemia
acute myeloid leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia
adult acute myeloid leukemia in remission
aplastic anemia
childhood acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia in remission
 childhood acute myeloid leukemia
childhood acute myeloid leukemia in remission
de novo myelodysplastic syndrome
hematologic disorders
hematopoietic/lymphoid cancer
leukemia
myelodysplastic syndrome
oncologic disorders
previously treated myelodysplastic syndrome
rare disease
secondary myelodysplastic syndrome

Additional relevant MeSH terms:
Anemia
Fanconi Anemia
Fanconi Syndrome
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Precancerous Conditions
Cyclophosphamide
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2013