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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

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ClinicalTrials.gov Identifier: NCT00005892
Recruitment Status : Completed
First Posted : June 5, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)

Brief 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.


Condition or disease Intervention/treatment Phase
Fanconi's Anemia Myelodysplastic Syndromes Leukemia, Nonlymphocytic, Acute Leukemia, Lymphocytic, Acute Drug: cyclophosphamide Procedure: Allogeneic Bone Marrow Transplantation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : March 2000






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Ages Eligible for Study:   up to 54 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00005892     History of Changes
Other Study ID Numbers: 199/15100
UMN-MT-1985-01
UMN-MT-8501
First Posted: June 5, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2004

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:
Syndrome
Leukemia
Anemia
Myelodysplastic Syndromes
Preleukemia
Fanconi Anemia
Fanconi Syndrome
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases