Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma
Yale University
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).
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 i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male/female patients who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (TNHL) will be enrolled in this study. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 unless compromised by lymphoma with anticipated benefit from chemotherapy as determined and documented by the investigator. 3. Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including but not limited to: * Peripheral T-cell lymphoma not otherwise specified (PTCL nos) * Angioimmun…
Interventions
- DrugMogamulizumab
Mogamulizumab is a defucosylated, humanized, monoclonal antibody (Mab) with enhanced antibody dependent cellular cytotoxicity that binds to CCR4. The lack of fucose results in the antibody eliciting more potent ADCC than conventionally produced antibodies. Mogamulizumab is devoid of complement dependent cytotoxicity. CC Chemokine receptor 4 is over expressed on the surfaces of cells comprising several T-cell malignancies such as peripheral T-cell lymphoma (PTCL) and CTCL and is a potential target for anti-neoplastic therapy in these disorders.
- DrugDA-EPOCH Protocol
EPOCH is an intensive chemotherapy regimen intended for treatment of aggressive non-Hodgkin's lymphoma.
- DrugCHOEP protocol
CHOEP is an intensive chemotherapy intended for treatment of aggressive t-cell lymphoma.
Locations (2)
- Yale Cancer Center, Clinical Trials OfficeNew Haven, Connecticut
- Icahn School of Medicine at Mount SinaiNew York, New York