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Study of Mogamulizumab with Chemotherapy for Aggressive T-cell Lymphoma

This study is looking at a new way to treat aggressive T-cell lymphoma, including Adult T-cell leukemia/lymphoma (ATLL). It combines a drug called mogamulizumab with standard chemotherapy treatments, either DA-EPOCH or CHOEP. Mogamulizumab is a special antibody that helps your body fight cancer cells. The study aims to see how many patients achieve a complete response (meaning the cancer is no longer detectable) after 6 cycles of this combination treatment. You may be able to join if you are at least 18 years old and have been diagnosed with T-cell Non-Hodgkin lymphoma. The study plans to enroll up to 22 patients. The current recruitment status is unclear.

Study design
This is a single-arm, open-label Phase II study, meaning all participants receive the same treatment and both you and the study team will know what treatment you are getting. It plans to enroll a maximum of 22 patients.
What's involved
You would receive mogamulizumab along with DA-EPOCH or CHOEP chemotherapy for 6 cycles. Response assessments will happen at specific times.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures complete response after 6 cycles (126 days) of treatment. It is not specified how long participants will be followed after this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05996185

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Yale University
~22 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:MogamulizumabDA-EPOCH ProtocolCHOEP protocol

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response after 6 cycles of treatment with the combination Mogamulizumab and standard of care DA-EPOCH or CHOEP
Measured over 6 cycles (126 Days)

Conditions

T Cell Lymphoma
T-cell Lymphoma

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NCT05996185

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Yale Cancer Center, Clinical Trials Office

    New Haven, Connecticutstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tarsheen Sethi, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Carole Ramm
[email protected]
(203) 785-4095
Email the study team

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Eligibility criteria

Inclusion

Peripheral T-cell lymphoma not otherwise specified (PTCL nos)
Angioimmunoblastic T-cell lymphoma (AITL)
Anaplastic large-cell lymphoma (ALCL)
Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)/sezary syndrome patients for whom multi-agent chemotherapy is indicated
Transformed mycosis fungoides/Sézary syndrome
Enteropathy-associated T-cell lymphoma (EATL)
Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)
Hepatosplenic T- cell lymphomas
Gamma delta T-cell lymphomas
Adult T-cell lymphoma leukemia (ATLL)
T-prolymphocytic leukemia with nodal or visceral involvement 4. Prior therapy- patients with aggressive T-cell lymphoma may have received one cycle of CHOP, CHOEP or EPOCH before enrollment, if necessary, to control the disease. 5. For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥ 1.5 cm 6. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR
A woman of childbearing potential (WOCBP) - see Appendix 4 for definition of WOCBP - must have a negative serum or urine pregnancy test during screening and must agree to follow instructions for using acceptable contraception (Appendix 5) from the time of signing consent, and at least 180 days (6 months) after her final dose of mogamulizumab. 7. A male patient must agree to use a contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least at least 180 days (6 months) after her final dose of mogamulizumab and refrain from donating sperm during this period. 8. Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment unless compromised by disease involvement of bone marrow, spleen, or liver as determined and documented by the investigator. 9. Patients previously treated with anti-CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are ≥ 200/mm.

What this trial measures

  • Complete response after 6 cycles of treatment with the combination Mogamulizumab and standard of care DA-EPOCH or CHOEP6 cycles (126 Days)

    As assessed by the Lugano criteria for PTCL(16) and the global response score for CTCL(17)