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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05996185
Phase
PHASE2
Status
Recruiting
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Conditions

  • T Cell Lymphoma
  • T-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Oct 9, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mogamulizumab + DA-EPOCH or CHOEP
    All subjects are scheduled to receive six cycles of DA-EPOCH + Mogamulizumab Cycle 1: Mogamulizumab on days 1,8,15, of a 21-day cycle with DA-EPOCH on day 1. Cycles 2 to 6: Mogamulizumab on day 1 with DA-EPOCH or CHOEP Mogamulizumab will be administered modified to a 21-day cycle in combination with chemotherapy. Subjects will receive 1.0 mg/kg of mogamulizumab as an IV infusion over at least 1 hour on Days 1, 8, 15 of the first cycle and Day 1 for the subsequent cycles. This is based on prior studies with mogamulizumab in combination of chemotherapy.(15) This dosing regimen will ensure the first 4 doses are given weekly at a dose of 1 mg/kg. Subsequent dosing on a 21-day schedule to coincide with the frequency of administration of DA-EPOCH or CHOEP to allow for simpler co-administration of the study drugs. In addition, this study proposes to leverage the immunomodulatory role of mogamulizumab, the dosing for this has not been previously established or explored.

Primary Outcome Measure

Complete response after 6 cycles of treatment with the combination Mogamulizumab and standard of care DA-EPOCH or CHOEP [ Time Frame: 6 cycles (126 Days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Cancer Center, Clinical Trials OfficeNew HavenConnecticut06510
Daniel Moncayo
[email protected]
203-500-0834
Tarsheen Sethi, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Martin van Voorthuysen
[email protected]
646-745-6092
Roshan Asrani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale Cancer Center, Clinical Trials Office· New Haven, CTIcahn School of Medicine at Mount Sinai· New York, NY

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