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Monoclonal Antibodies

Epcoritamab for Chronic Lymphocytic Leukemia (EPCORE™ CLL-1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Genmab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy.
For RS - R-CHOP combination Therapy Arm - Eligible for treatment with R-CHOP.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Who is the study for?
This trial is for patients with relapsed/refractory chronic lymphocytic leukemia or Richter's Syndrome who have tried other treatments. They must have a life expectancy over 3 months, acceptable organ function, and specific performance status. Prior therapies are required for certain arms of the study, and they must not have had certain conditions like HIV or recent major surgery.Check my eligibility
What is being tested?
Epcoritamab is being tested both alone and in combination with venetoclax, lenalidomide, or R-CHOP (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone) to treat chronic lymphocytic leukemia and Richter's Syndrome. The trial has two phases: dose escalation to find safe levels and expansion to test effectiveness.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to epcoritamab targeting CD20 on cancer cells. Other side effects may arise from chemotherapy combinations such as nausea, hair loss, increased infection risk, fatigue, blood disorders.

EPCORE™ CLL-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have CLL and have had at least one treatment before considering venetoclax.
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I am eligible for R-CHOP treatment.
Select...
My bloodwork shows my organs are functioning well.
Select...
My cancer can be measured using PET, CT, or MRI scans.
Select...
My disease shows CD20 positivity in tests.
Select...
My doctor expects me to live more than 3 months with standard treatment.
Select...
I can provide a specific type of tumor biopsy sample.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
My chronic lymphocytic leukemia needs treatment according to 2018 guidelines.
Select...
I have CLL and have been treated with at least 2 therapies, including a BTK inhibitor.
Select...
My cancer is CD20+ DLBCL and I have a history of CLL/SLL.
Select...
I cannot or choose not to undergo intensive chemotherapy for my condition.
Select...
I can't or won't have intensive chemo but can take lenalidomide and follow its safety guidelines.

EPCORE™ CLL-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation Phase (R/R CLL arm): Number of Participants with Dose Limiting Toxicities (DLTs)
Dose Escalation Phase: Number of Participants with Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Clinical Tumor Lysis Syndrome (CTLS)
Dose Escalation Phase: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
+1 more
Secondary outcome measures
Both Phases: AUC From Time Zero to Infinity (AUCinf) in Epcoritamab
Both Phases: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) in Epcoritamab
Both Phases: Duration of MRD Negativity
+19 more

EPCORE™ CLL-1 Trial Design

5Treatment groups
Experimental Treatment
Group I: Epcoritamab in RSExperimental Treatment1 Intervention
Only in expansion phase.
Group II: Epcoritamab in R/R CLL/SLLExperimental Treatment1 Intervention
In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.
Group III: Epcoritamab + Venetoclax in R/R CLL/SLLExperimental Treatment2 Interventions
In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.
Group IV: Epcoritamab + R-CHOP in RSExperimental Treatment2 Interventions
Only in expansion phase.
Group V: Epcoritamab + Lenalidomide in RSExperimental Treatment2 Interventions
Only in expansion phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor
56 Previous Clinical Trials
12,048 Total Patients Enrolled
AbbVieIndustry Sponsor
950 Previous Clinical Trials
496,744 Total Patients Enrolled

Media Library

Epcoritamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04623541 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: Epcoritamab in R/R CLL/SLL, Epcoritamab in RS, Epcoritamab + Venetoclax in R/R CLL/SLL, Epcoritamab + Lenalidomide in RS, Epcoritamab + R-CHOP in RS
Chronic Lymphocytic Leukemia Clinical Trial 2023: Epcoritamab Highlights & Side Effects. Trial Name: NCT04623541 — Phase 1 & 2
Epcoritamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04623541 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~112 spots leftby Jun 2029