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Chemotherapy
Mogamulizumab + DA-EPOCH for T-Cell Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Sethi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study a new drug for treating aggressive T cell lymphoma and Adult T-cell leukemia/lymphoma.
Who is the study for?
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.
What is being tested?
The study is testing the effectiveness of Mogamulizumab when added to the DA-EPOCH chemotherapy regimen in patients with newly diagnosed or relapsed/refractory aggressive T cell lymphoma. It's a Phase II trial where all participants receive this combination treatment.
What are the potential side effects?
Mogamulizumab can cause skin reactions, infusion-related symptoms, fatigue, immune system effects that might lead to serious infections, and complications from organ inflammation. The DA-EPOCH chemotherapy may add side effects like nausea, hair loss, low blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response after 6 cycles of treatment with the combination Mogamulizumab and standard of care DA-EPOCH
Secondary study objectives
Duration of response
Occurrence of toxicity
Overall survival (OS)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mogamulizumab + DA-EPOCHExperimental Treatment2 Interventions
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.
Cycle 2 onwards: Mogamulizumab on day 1 with DA-EPOCH
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 dosing regimen will ensure the first 4 doses are given weekly at a dose of 1 mg/kg. Subsequent dosing will occur on a 21-day schedule to coincide with the frequency of administration of DA-EPOCH to allow for simpler co-administration of the study drugs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mogamulizumab
2016
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
SethiLead Sponsor
1 Previous Clinical Trials
43 Total Patients Enrolled
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,646 Total Patients Enrolled
Tarsheen SethiLead Sponsor
1 Previous Clinical Trials
43 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cancer treatment recently.I have recently undergone radiotherapy.I am taking drugs that modify my immune system.I have not received a live vaccine recently.I do not have an active TB infection.I have had a stem cell transplant from a donor or I am experiencing complications from it.I have received specific chemotherapy for aggressive T cell lymphoma.I am not pregnant or breastfeeding.My organs and bone marrow are working well.I have an infection that is not under control.I was diagnosed with cancer within the last 2 years.I have active brain metastases or carcinomatous meningitis.I can care for myself but may not be able to do heavy physical work, unless my condition is expected to improve with chemotherapy.I have been treated with anti-CD4 antibody or alemtuzumab and meet the CD4+ cell count requirement.I am currently being treated for an active autoimmune disease.My condition is a type of T-cell Non-Hodgkin lymphoma.I agree to follow the required contraception methods.I have a history of HIV or Hepatitis B/C.I have had major surgery recently.I am 18 or older with a confirmed diagnosis of T-cell Non-Hodgkin lymphoma.I do not have active heart inflammation or severe heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Mogamulizumab + DA-EPOCH
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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