Acute Myeloid Leukemia Clinical Trial
Official title:
Bridging Study: A Phase 2 Study Investigating Clofarabine, Cyclophosphamide and Etoposide for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia and Minimal Residual Disease
This is a Phase 2 study designed for the purpose of estimating various parameters surrounding
the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual
disease (MRD) in acute leukemia patients otherwise in remission and without causing
significant delay of HCT due to treatment related toxicity.
A single course of "bridge" chemotherapy is given prior to the transplant procedure as an
approach to improved disease-free survival in a patient group who historically has had
inferior outcomes.
Study entry is open to patients regardless of gender or ethnic background.
The intent of this study design is for all patients to receive and complete one course of
therapy. Patients who exhibit signs of disease progression or experience an unacceptable
toxicity will be discontinued from treatment.
There will be no dose delays or dose reductions of study drugs for hematologic toxicity
during Consolidation "Bridging" therapy (Day 1 through Day 30); however, prolonged
hematopoietic recovery or bone marrow aplasia during the first 42 days may meet a study
stopping rule.
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