Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma
NCT05996185 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-04-14
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).
Conditions
Interventions
- DRUG
-
CHOEP protocol
CHOEP is an intensive chemotherapy intended for treatment of aggressive t-cell lymphoma.
- 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.
Sponsors & Collaborators
-
Yale University
lead OTHER -
Kyowa Kirin, Inc.
collaborator INDUSTRY
Principal Investigators
-
Tarsheen Sethi, MD · Yale University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-09
- Primary Completion
- 2026-11-30
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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