RecruitingPhase 2NCT05996185

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

Sponsor

Yale University

Enrollment

22 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

T-cell Lymphoma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing mogamulizumab (an immunotherapy that targets a protein called CCR4 found on certain cancer cells) combined with standard chemotherapy for people with aggressive T-cell lymphomas (cancers of a type of immune cell called T-cells). **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of T-cell non-Hodgkin lymphoma (T-NHL), such as peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma, or similar types - You are in reasonably good overall health (ECOG 0–2) - This is your first treatment for this type of lymphoma **You may NOT be eligible if...** - Your lymphoma is a B-cell type, not T-cell - You are in very poor health unrelated to your lymphoma - You have received prior treatment for this T-cell lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Office

New Haven, Connecticut, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05996185

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