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Chemotherapy
Epcoritamab + GDP for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Dipenkumar Modi, MD
Research Sponsored by Dipenkumar Modi
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 4 years
Awards & highlights
Study Summary
This trial studies a combination of chemotherapy and immunotherapy to treat large cell lymphoma that has come back.
Who is the study for?
Adults over 18 with CD20+ relapsed large cell lymphoma, who've had at least one prior systemic therapy and are eligible for high dose chemotherapy and stem cell transplant. They must have measurable disease, adequate organ function, a life expectancy of more than 6 months, and agree to use contraception. HIV-positive patients can join if treated; those with hepatitis B or C must meet specific criteria.Check my eligibility
What is being tested?
The trial tests Epcoritamab combined with GDP (gemcitabine, dexamethasone, cisplatin) chemotherapy in three cycles for treating relapsed large cell lymphoma. Afterward, patients may receive autoSCT/CAR T-cell therapy or continue epcoritamab alone based on the doctor's discretion.See study design
What are the potential side effects?
Possible side effects include reactions to epcoritamab injections like skin irritation or pain at the injection site. Chemotherapy may cause nausea, fatigue, hair loss, increased risk of infection due to low blood counts and potential kidney damage from cisplatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR)
Secondary outcome measures
Duration of Response (DOR)
Feasibility of AutoSCT or CAR T-cell
Overall Response Rate (ORR)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: GDP + Epcoritamab + Epcoritamab MaintenanceExperimental Treatment2 Interventions
Cycles 1-3 (Cycle = 21 days) Epcoritamab will be administered by subcutaneous injection Days 1, 8, and 15 of each Cycle.
Epcoritamab Day 1: 0.16mg, Day 8: 0.8mg, Day 15: 48mg except Cycle 2-Epcoritabab will administered at 48mg on Days 1, 8 and 15
Gemcitabine will be administered by IV infusion on Days 1 and 8 of each Cycle. Gemcitabine Days 1,8: 1,000mg/m^2
Cisplatin will be administered by IV infusion on Day 1 of each Cycle. Cisplatin Day 1: 75mg/m^2
Dexamethasone will be given by mouth on Days 1-4 of Cycle 1 ONLY. Dexamethasone Days 1-4: 40mg
Cycles 4-9 (Cycle =28 Days) Epcoritamab will be administered by subcutaneous injection on Days 1, 8, and 15 of Cycles 4-9.
Group II: GDP + Epcoritamab + AutoSCT or CAR T-cell therapyExperimental Treatment3 Interventions
Cycles 1-3 (Cycle = 21 days) Epcoritamab will be administered by subcutaneous injection Days 1, 8, and 15. Epcoritamab Day 1: 0.16mg, Day 8: 0.8mg, Day 15: 48mg except Cycle 2-Epcoritamab will administered at 48mg on Days 1, 8 and 15
Gemcitabine will be administered by IV infusion on Days 1 and 8. Gemcitabine Days 1,8: 1,000mg/m^2
Cisplatin will be administered by IV infusion on Day 1. Cisplatin Day 1: 75mg/m^2
Dexamethasone will be given by mouth on Days 1-4. Dexamethasone Days 1-4: 40mg
After completion of Cycle 3 Autologous stem cell transplant (AutoSCT) OR CAR T-cell therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GDP
2019
N/A
~250
Find a Location
Who is running the clinical trial?
Dipenkumar ModiLead Sponsor
GenmabIndustry Sponsor
56 Previous Clinical Trials
12,200 Total Patients Enrolled
Dipenkumar Modi, MDPrincipal InvestigatorWayne State University
1 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and follow the study's procedures for its duration.I have moderate to severe nerve pain or numbness.My lymphoma has returned and tests show it is CD20 positive.I have been mostly active and able to care for myself in the last 28 days.I do not have any current infections or significant infections in the last 2 weeks.My organs are functioning well.I have had cancer before, but it fits the exceptions.My doctor agrees I can undergo high dose chemotherapy and stem cell transplant or CAR T-cell therapy.I am a woman who can have children and I have a recent negative pregnancy test.I have a history of chronic hepatitis B.I have been treated with specific drugs before.My large cell lymphoma has spread to my brain or its coverings.I am allergic or react badly to drugs in the GDP therapy.I still have side effects from lymphoma treatment that are not mild.I have not had major surgery within the last 14 days.I have an autoimmune disease or need ongoing immunosuppressive therapy.I am willing to use birth control or abstain from sex.I am HIV-positive and on effective anti-retroviral therapy.My cancer came back or didn't respond after initial chemotherapy.I am 18 years old or older.I haven't used any lymphoma treatments in the last 14 days.I have had at least one treatment for large cell lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: GDP + Epcoritamab + AutoSCT or CAR T-cell therapy
- Group 2: GDP + Epcoritamab + Epcoritamab Maintenance
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are anticipated to take part in this trial?
"Affirmative. Clinicaltrials.gov evidence confirms that this clinical trial, first uploaded on August 1st 2023, is currently recruiting patients from one location in need of 32 participants."
Answered by AI
Is the opportunity to participate in this research still available?
"Aye, the information displayed on clinicaltrials.gov indicates that this experiment is actively seeking participants. This trial was first published on August 1st 2023 and has been newly updated as of July 24th 2023. 32 individuals need to be included from a single medical centre."
Answered by AI
To what extent can GDP + Epcoritamab + AutoSCT be deemed secure for patients?
"Although GDP + Epcoritamab + AutoSCT has yet to be confirmed effective, there is some data that suggests its safety rating merits a score of 2."
Answered by AI
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