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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

Primary Purpose

Fanconi's Anemia, Myelodysplastic Syndromes, Leukemia, Nonlymphocytic, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
Allogeneic Bone Marrow Transplantation
Sponsored by
Fairview University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fanconi's Anemia focused on measuring 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

Eligibility Criteria

0 Years - 54 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fairview University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 23, 2005
Sponsor
Fairview University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00005892
Brief Title
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fairview University Medical Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fanconi's Anemia, Myelodysplastic Syndromes, Leukemia, Nonlymphocytic, Acute, Leukemia, Lymphocytic, Acute
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Procedure
Intervention Name(s)
Allogeneic Bone Marrow Transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J. Weisdorf
Organizational Affiliation
Fairview University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fairview University Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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