Fanconi's AnemiaNCT00005892
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia
A study testing cyclophosphamide and Allogeneic Bone Marrow Transplantation in people with Fanconi's Anemia and Myelodysplastic Syndromes, run by Fairview University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 54 years
- Conditions the study is for
- Fanconi's Anemia, Myelodysplastic Syndromes, Leukemia, Nonlymphocytic, Acute
- What is being tested?
- cyclophosphamide and Allogeneic Bone Marrow Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to not given
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 54 years
- All sexes
- No healthy volunteers
- Child, Adult
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fairview University Medical Center
Minneapolis, Minnesota, 55455
About this study
OBJECTIVES:
- 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.
Read the 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.
- Conditions
- Fanconi's Anemia, Myelodysplastic Syndromes, Leukemia, Nonlymphocytic, Acute, Leukemia, Lymphocytic, Acute
- Being tested
- cyclophosphamide, Allogeneic Bone Marrow Transplantation
- 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
- Medical subject headings
- Fanconi Anemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute, Anemia, Aplastic, Hematologic Diseases, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Allogeneic Bone Marrow TransplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2000 (estimated)
- Study startMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fanconi's AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Fairview University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Daniel J. Weisdorf, Study chair, Fairview University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005892
- Sponsor's protocol ID
- 199/15100
- Other IDs
- UMN-MT-1985-01, UMN-MT-8501
- Status last verified
- Jul 2004
- First submitted
- 2 Jun 2000
- Last updated
- 24 Jun 2005
- Results posted
- No