Mogamulizumab + DA-EPOCH for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
Single- arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T cell lymphoma including patients with Adult T-cell leukemia/lymphoma (ATLL).
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are on certain immunomodulatory drugs or have received them within 4 weeks of treatment, you may be excluded from participating. It's best to discuss your specific medications with the trial team.
Is the combination of Mogamulizumab and DA-EPOCH safe for humans?
The DA-EPOCH regimen, used for aggressive lymphomas, has been studied and found to be generally safe, with common side effects including neutropenia (low white blood cell count) and infections. There were no treatment-related deaths reported in the studies, but some patients experienced severe infections. Mogamulizumab, another component of the treatment, has been used in other conditions, but specific safety data for its combination with DA-EPOCH in T-cell lymphoma is not provided in the available studies.12345
How is the treatment Mogamulizumab + DA-EPOCH for T-Cell Lymphoma different from other treatments?
Mogamulizumab + DA-EPOCH is unique because it combines a targeted therapy (mogamulizumab) with a dose-adjusted chemotherapy regimen (DA-EPOCH) to potentially improve outcomes for T-cell lymphoma, a condition with limited standard treatment options. This approach aims to enhance the effectiveness of chemotherapy by adjusting doses based on patient tolerance and adding a drug that specifically targets cancer cells.36789
What data supports the effectiveness of the treatment Mogamulizumab + DA-EPOCH for T-Cell Lymphoma?
Who Is on the Research Team?
Tarsheen Sethi
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
Adults with confirmed aggressive T-cell Non-Hodgkin lymphoma, including various subtypes like PTCL and CTCL, can join this trial. They should have a decent performance status (able to carry out daily activities) and may have had one cycle of certain chemotherapies. Women must not be pregnant or breastfeeding and agree to use contraception; men also need to commit to using contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Mogamulizumab and DA-EPOCH for 6 cycles, with Mogamulizumab administered on days 1, 8, 15 of the first cycle and day 1 of subsequent cycles, and DA-EPOCH on day 1 of each cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for complete response and occurrence of toxicity
Extension/Long-term follow-up
Participants are monitored for progression-free survival, overall survival, and duration of response
What Are the Treatments Tested in This Trial?
Interventions
- DA-EPOCH Protocol
- Mogamulizumab
DA-EPOCH Protocol is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sethi
Lead Sponsor
Yale University
Lead Sponsor
Tarsheen Sethi
Lead Sponsor
Kyowa Kirin, Inc.
Industry Sponsor