NCT05996185

Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma

Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T Cell Lymphoma
• T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Mogamulizumab	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.
DRUG	DA-EPOCH Protocol	EPOCH is an intensive chemotherapy regimen intended for treatment of aggressive non-Hodgkin's lymphoma.
DRUG	CHOEP protocol	CHOEP is an intensive chemotherapy intended for treatment of aggressive t-cell lymphoma.

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2023-08-18
• Last updated: 2026-04-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study