Status:
COMPLETED
Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Fanconi Anemia
Eligibility:
All Genders
Up to 59 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, before a donor stem cell transplant helps to remove the patient's cells to allow for the transplant cells to take and grow. It...
Detailed Description
OBJECTIVES: Primary * To determine the probability of engraftment in patients with Fanconi anemia treated with cyclophosphamide, fludarabine phosphate, and antithymocyte globulin followed by HLA-gen...
Eligibility Criteria
Inclusion
- Patients must be \<60 years of age with a diagnosis of Fanconi Anemia (FA).
- Patients must have an HLA-A, B, DRB1 identical sibling donor. Patients and donors will be typed for HLA-A and B using serological or molecular techniques and for DRB1 using high resolution molecular typing.
- Patients with FA must have moderately severe aplastic anemia (AA), early myelodysplastic syndrome (MDS) with no excess blasts with or without chromosomal abnormalities.
- In patients \<18 years of age, moderately severe aplastic anemia is defined as having at least one of the following:
- platelet count \<40 x 10\^9/L
- absolute neutrophil count (ANC) \<10 x 10\^8/L
- Hgb \<9 g/dL
- In patients 18-60 years of age, moderately severe aplastic anemia is defined as having at least one of the following:
- platelet count \<20 x 10\^9/L
- absolute neutrophil count ANC \<5 x 10\^8/L
- Hgb \<8 g/dL
- Early myelodysplastic syndrome, with multilineage dysplasia with \< 5% blasts, with or without chromosomal anomalies.
- Adequate major organ function including:
- Cardiac: ejection fraction \>45%
- Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- Karnofsky performance status \>70% or Lansky \>50%
- Women of child bearing age must be using adequate birth control and have a negative pregnancy test.
Exclusion
- Active bacterial infection within one week of hematopoietic cell transplant (HCT)
- Active fungal infection at time of HCT.
- Late MDS with greater than 5% blasts in bone marrow.
- Acute myelogenous leukemia (AML) or history of AML
- Malignant solid tumor (e.g. squamous cell carcinoma of the head/neck/cervix) within 2 years of HCT.
- Pregnant or lactating female.
Key Trial Info
Start Date :
February 17 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00630253
Start Date
February 17 2000
End Date
October 10 2020
Last Update
October 12 2021
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455