T Cell Lymphoma Clinical Trial
Official title:
Phase II Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma
Single- arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T cell lymphoma including patients with Adult T-cell leukemia/lymphoma (ATLL).
This is a single arm, open label, multicenter phase 2 study of DA-EPOCH and Mogamulizumab in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T-cell lymphomas including ATLL and transformed Mycosis Fungoides/Sézary syndrome (MF/SS). The hypothesis is that this combination is effective and will produce a CR rate of 80%. DA-EPOCH and Mogamulizumab will be administered for 6 cycles and depending on the histology, consolidative strategies including SCT will be considered. Response assessments will occur at pre-specified intervals. Dose adjustments for specific toxicities with drugs are detailed in the protocol. Based on statistical analysis, a maximum of 36 patients will need to be accrued to evaluate for disease response based on historical control. ;
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