- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005892
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Fairview University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Daniel J. Weisdorf, Fairview University Medical Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- rare disease
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- adult acute myeloid leukemia in remission
- acute myeloid leukemia
- aplastic anemia
- leukemia
- myelodysplastic syndrome
- adult acute lymphoblastic leukemia in remission
- acute undifferentiated leukemia
- hematopoietic/lymphoid cancer
- acute leukemia
- hematologic disorders
- adult acute myeloid leukemia
- childhood acute lymphoblastic leukemia
- Fanconi's anemia
- adult acute lymphoblastic leukemia
- acute lymphocytic leukemia
- oncologic disorders
- childhood acute myeloid leukemia
- de novo myelodysplastic syndrome
- previously treated myelodysplastic syndrome
- secondary myelodysplastic syndrome
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Kidney Diseases
- Urologic Diseases
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- DNA Repair-Deficiency Disorders
- Precancerous Conditions
- Anemia, Hypoplastic, Congenital
- Anemia, Aplastic
- Congenital Bone Marrow Failure Syndromes
- Bone Marrow Failure Disorders
- Renal Tubular Transport, Inborn Errors
- Leukemia, Myeloid
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid, Acute
- Preleukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Anemia
- Fanconi Syndrome
- Fanconi Anemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- 199/15100
- UMN-MT-1985-01
- UMN-MT-8501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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