Fanconi Anemia Transplant Lacking Genotypically Identical Donor
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2009 |
Multicenter Phase II Trial-Hematopoietic Stem Cell Transplantation for Treatment of Patients With FA Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
A research study for patients with Fanconi Anemia whose bone marrow has changed and now
failed, giving rise to a pre-leukemia or leukemia. This study is a Phase II clinical trial
in which patients will undergo allogenic transplant of stem cells, meaning they will receive
bone marrow cells from a healthy donor. The purpose of this study is to see if transplant
course of treatment will lower the risk of graft vs. host disease.
failed, giving rise to a pre-leukemia or leukemia. This study is a Phase II clinical trial
in which patients will undergo allogenic transplant of stem cells, meaning they will receive
bone marrow cells from a healthy donor. The purpose of this study is to see if transplant
course of treatment will lower the risk of graft vs. host disease.
Inclusion Criteria:
- Diagnosis: Patients must have a diagnosis of Fanconi anemia (confirmed by mitomycin C
or diepoxybutane [DEB] chromosomal breakage testing at an approved laboratory)
- Hematologic Diagnosis and Status: Patients must have one of the following hematologic
diagnoses:
1. Severe Aplastic Anemia (SAA), or Severe Isolated Single lineage
Cytopenia with bone marrow cellularity of < 25% AND at least one of the
following features:
- Platelet count < 20 x 109/L or platelet transfusion dependence
- ANC < 1000 x 109/L
- Hgb < 8 gm/dl or red cell transfusion dependence
2. Myelodysplatic Syndrome (MDS) (Appendix 1: MDS Classification). MDS at any
stage, based on either one of the following classifications:
- WHO Classification
- Refractory anemia and transfusion dependence
- Any of other stages
- IPSS Classification
- Low risk (score 0) and transfusion dependence
- Any other risk groups Score > 0.5
3. Acute Myelogenous Leukemia: Patients with acute leukemia are included in this
trial in remission, refractory or relapsed disease
Exclusion Criteria:
- Active CNS leukemic involvement
- Female patients who are pregnant or breast-feeding
- Active uncontrolled viral, bacterial or fungal infection
- Patient seropositive for HIV-I/II; HTLV -I/II
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