Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma
brief summary
Single-arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) or CHOEP in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T-cell lymphoma including patients with Adult T-cell leukemia/lymphoma (ATLL).
detailed description
This is a single arm, open label, multicenter phase II study of DA-EPOCH or CHOEP 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 investigators hypothesize that this combination is effective and will produce a CR rate that is statistically larger than 40%, a rate based on historical data from the current standard of care. DA-EPOCH or CHOEP 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 22 patients will need to be accrued to obtain a sample of 19 evaluable patients for disease response.
official title
Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma