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

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

ChemIDplus related topics:

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

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

Leukemia, Lymphoid

Precancerous Conditions

Cyclophosphamide

Leukemia, Myeloid, Acute

Acute lymphoblastic leukemia, adult

Leukemia

Preleukemia

Fanconi's anemia

Anemia, Aplastic

Neoplasm Metastasis

Acute myeloid leukemia, adult

Acute myelocytic leukemia

Lymphoma

Myelodysplastic syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Metabolic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Fanconi Anemia

Myelodysplastic Syndromes

Myelodysplasia

Acute myelogenous leukemia

Rare Diseases

Anemia

Leukemia, Myeloid

Lymphatic Diseases

Genetic Diseases, Inborn

Metabolic disorder

Bone Marrow Diseases

Lymphoproliferative Disorders

Additional relevant MeSH terms:

Neoplasms by Histologic Type

Disease

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Immunologic Factors

Antineoplastic Agents

DNA Repair-Deficiency Disorders

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Anemia, Hypoplastic, Congenital

Pathologic Processes

Therapeutic Uses

Syndrome

Myeloablative Agonists

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Alkylating Agents

ClinicalTrials.gov processed this record on September 05, 2008

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