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

Sponsored by:	Fairview University Medical Center
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00005892

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

MedlinePlus related topics: Anemia Bone Marrow Transplantation Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Radiation Therapy

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Study ID Numbers:	199/15100, UMN-MT-1985-01, UMN-MT-8501
Study First Received:	June 2, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005892 History of Changes
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

Study placed in the following topic categories:

Acute Lymphoblastic Leukemia, Childhood
Leukemia, Lymphoid
Immunologic Factors
Precancerous Conditions
Aplastic Anemia
Cyclophosphamide
Leukemia, Myeloid, Acute
Fanconi's Anemia
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Anemia, Aplastic
Neoplasm Metastasis
Alkylating Agents

Metabolic Disorder
Lymphoma
Acute Lymphoblastic Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Metabolic Diseases
Immunoproliferative Disorders
Hematologic Diseases
Fanconi Anemia
Myelodysplastic Syndromes
Rare Diseases
Anemia
Leukemia, Myeloid
Immunosuppressive Agents
Acute Myeloid Leukemia, Childhood
Lymphatic Diseases

Additional relevant MeSH terms:

Leukemia, Lymphoid
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Precancerous Conditions
Antineoplastic Agents
Physiological Effects of Drugs
DNA Repair-Deficiency Disorders
Cyclophosphamide
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Therapeutic Uses
Syndrome
Anemia, Aplastic

Alkylating Agents
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Metabolic Diseases
Neoplasms by Histologic Type
Immunoproliferative Disorders
Disease
Immune System Diseases
Hematologic Diseases
Fanconi Anemia
Myelodysplastic Syndromes
Anemia
Leukemia, Myeloid
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009