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Epcoritamab for Chronic Lymphocytic Leukemia (EPCORE™ CLL-1 Trial)
EPCORE™ CLL-1 Trial Summary
This trial is testing a new drug for people with cancer who have tried other treatments that haven't worked. The drug will be given to people in different doses to see what works best, and then given to more people to see if it is safe and effective.
EPCORE™ CLL-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEPCORE™ CLL-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EPCORE™ CLL-1 Trial Design
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Who is running the clinical trial?
Media Library
- I have a serious heart condition.I have CLL and have had at least one treatment before considering venetoclax.I took venetoclax in the last 2 years and my condition worsened on it.I am eligible for R-CHOP treatment.I have had more than 2 treatments for my condition before considering this therapy.I do not have any cancer other than the one I am seeking treatment for.My bloodwork shows my organs are functioning well.I haven't had CAR T-cell therapy in the last 100 days or any experimental drugs in the last 4 weeks.My cancer can be measured using PET, CT, or MRI scans.My condition is Richter's syndrome, not including the DLBCL type.I had major surgery less than 4 weeks ago.I have an autoimmune disease or require high-dose immunosuppressants.I have had a stem cell or organ transplant before.I have a known history of HIV.My disease shows CD20 positivity in tests.My doctor expects me to live more than 3 months with standard treatment.I have not received a live vaccine in the last 28 days.I have active hepatitis B or C.My CLL may have transformed into a more aggressive form.I can provide a specific type of tumor biopsy sample.I can take care of myself and am up and about more than half of my waking hours.My chronic lymphocytic leukemia needs treatment according to 2018 guidelines.I have CLL and have been treated with at least 2 therapies, including a BTK inhibitor.My cancer is CD20+ DLBCL and I have a history of CLL/SLL.I cannot or choose not to undergo intensive chemotherapy for my condition.I can't or won't have intensive chemo but can take lenalidomide and follow its safety guidelines.I have been treated with a specific dual-targeted antibody therapy before.
- Group 1: Epcoritamab in RS
- Group 2: Epcoritamab in R/R CLL/SLL
- Group 3: Epcoritamab + R-CHOP in RS
- Group 4: Epcoritamab + Lenalidomide in RS
- Group 5: Epcoritamab + Venetoclax in R/R CLL/SLL
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What aims are this trial hoping to accomplish?
"According to the study sponsor, AbbVie, this trial's primary objective will be tracking adverse events over a given time frame. Additionally, secondary outcomes that are being measured include pharmacodynamic marker immune subset activation markers and minimal residual disease (MRD) negative status for peripheral blood and bone marrow aspirate as well as immunogenicity of epcoritamab antidrug-antibodies."
Are there any additional investigations that have explored the potential of Epcoritamab?
"Currently, 6 trials are being conducted to evaluate the efficacy of Epcoritamab. One is in its final phase while the remaining studies are primarily located in Solna, California with a total of 509 sites across the nation running research for this therapeutic agent."
Can you provide an estimate of the aggregate number of individuals enrolled in this experiment?
"AbbVie, the trial's sponsor, is in need of 102 individuals meeting all inclusion criteria to carry out this experiment. Patients will be recruited from Memorial Sloan Kettering Cancer Center and Memorial Healthcare System in New york and Florida respectively."
Is this investigation a pioneer in its field?
"Genmab first initiated research into Epcoritamab in 2018, with a trial that involved 700 patients. Subsequent Phase 1 & 2 trials led to the drug's approval and presently there are 6 ongoing clinical studies spanning 26 countries and 56 cities."
How many health care centers have been chosen to conduct this experiment?
"Currently, 10 sites are participating in this trial. These include clinics located in New york, Hollywood and Dallas, among other locations. It is recommended that patients select the closest clinic to them to alleviate travelling constraints."
Is this scientific experiment currently open to new participants?
"Affirmative. Per the details on clinicaltrials.gov, this medical research is presently enrolling participants. It was initially posted on November 30th 2020 and last modified on June 15th 2022; 102 patients are needed from 10 distinct sites for completion of the trial."
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