Actively Recruiting
Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma
Led by Yale University · Updated on 2026-04-14
22
Participants Needed
2
Research Sites
159 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
K
Kyowa Kirin, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older with confirmed T-cell Non-Hodgkin lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 unless affected by lymphoma
- Diagnosed with specific T-cell lymphoma subtypes including PTCL, AITL, ALCL, CTCL, transformed MF/Sézary syndrome, EATL, SCPTCL, hepatosplenic T-cell lymphoma, gamma delta T-cell lymphoma, ATLL, or T-prolymphocytic leukemia
- Patients may have received one prior cycle of CHOP, CHOEP, or EPOCH if needed
- For PTCL patients, at least one measurable lesion of 1.5 cm or larger
- Women must not be pregnant or breastfeeding and agree to use contraception if of childbearing potential
- Men must agree to use contraception during and for 6 months after treatment
- Adequate organ and bone marrow function within 10 days before starting treatment unless disease-related
- Prior treatment with anti-CD4 antibody or alemtuzumab allowed if CD4+ count is 200/mm or higher
You will not qualify if you...
- Received systemic anti-cancer therapy, including investigational agents, within 3 weeks before first treatment dose
- Radiotherapy within 2 weeks before treatment unless recovered from side effects
- Recent major surgery without adequate recovery
- Use of immunomodulatory drugs for other conditions within 4 weeks before treatment, except topical steroids for CTCL
- Pregnant or breastfeeding women or positive pregnancy test within 72 hours before treatment
- Received live vaccines within 30 days before treatment
- Participation in other investigational studies or use of investigational devices within 4 weeks
- Active uncontrolled infection requiring treatment
- Active myocarditis or severe heart failure (NYHA class III-IV)
- Active central nervous system metastases or carcinomatous meningitis
- Other recent malignancies except certain treated cancers without evidence of disease
- Severe allergic reactions to study drugs or their components
- Known HIV infection
- Active Hepatitis B or Hepatitis C infection
- Psychiatric or substance abuse disorders interfering with study compliance
- History of active tuberculosis
- Allogeneic stem cell transplant within 2 years or active graft-versus-host disease
- Active autoimmune diseases requiring medical treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Yale Cancer Center, Clinical Trials Office
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
C
Carole Ramm
CONTACT
S
Stephanie Ladd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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