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Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (EPCORE™ CLL-1)

Primary Purpose

Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Epcoritamab
rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
Venetoclax
Epcoritamab
Lenalidomide
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Chronic Lymphocytic Leukemia focused on measuring DuoBody®, Bispecific antibodies, Anti-CD3, Anti-CD20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

  1. Subject must sign an ICF and be at least 18 years of age
  2. ECOG performance status score of 0, 1 or 2
  3. Screening evidence of CD20 positivity
  4. Has laboratory parameters - HBG-≥9.0 g/dL; ANC-≥1.0 x 109/L; Platelets-≥30 x 109/L
  5. Received a cumulative dose of corticosteroids less than the equivalent of 250 mg of prednisone within the 2-week period before the first dose
  6. Availability of fresh bone marrow material
  7. A woman must not be of childbearing potential and practicing a highly effective method of birth control, with a negative serum beta-hCG and urine pregnancy test at screening.
  8. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.
  9. For R/R CLL Cohort - Must have active CLL disease requiring treatment per iwCLL2018
  10. For R/R CLL Cohort - received at least 2 prior lines of systemic anti-neoplastic therapy anti-neoplastic therapy including a BTK inhibitor
  11. For R/R CLL Cohort - Measurable Disease ≥5 × 109/L (5,000/μL) B lymphocytes in peripheral blood or Presence of measurable lymphadenopathy and/or organomegaly
  12. For RS Cohort - Documented clinical history transformation to diffuse large B cell lymphoma (DLBCL)
  13. For RS Cohort - Not eligible for chemoimmunotherapy
  14. For RS Cohort - must have detectable disease by PET scan and measurable by CT scan or MRI

Key Exclusion Criteria

  1. Received prior treatment with a CD3 × CD20 bispecific antibody.
  2. Received any prior allogeneic HSCT or solid organ transplantation.
  3. Received treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or CAR T-cell therapy or investigational drug within 2 weeks.
  4. Received chemotherapy or radiation therapy within 2 weeks of the first dose of epcoritamab.
  5. Concomitant disease requiring permanent or high-dose immunosuppressive therapy.
  6. Received vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.
  7. Clinically significant cardiac disease
  8. Major surgery within 4 weeks
  9. Hepatitis B or C seropositivity (unless clearly due to vaccination)
  10. History of human immunodeficiency virus (HIV)
  11. Unable or unwilling to comply with contraceptive requirements during treatment and for 12 months after last dose of of epcoritamab.
  12. For R/R CLL Cohort - Any history of RS or evidence indicating a potential Richter's transformation.
  13. For RS Cohort - Transformation of CLL to Hodgkin variant of RS
  14. For RS Cohort - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
  15. For RS Cohort - Subject received autologous HSCT within 3 months prior to the first dose of epcoritamab.
  16. For RS Cohort - Subject received more than 1 prior line of therapy for RS.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of AlabamaRecruiting
  • City of HopeRecruiting
  • David Geffen School of MedicineRecruiting
  • University of Michigan Comprehensive Cancer CenterRecruiting
  • Henry Ford Medical GroupRecruiting
  • Hackensack Meridian HospitalRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of PennsylvaniaRecruiting
  • The University of Texas Southwestern Medical CentreRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • University Hospital of GeelongRecruiting
  • AZ Sint-JanRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • UZ LeuvenRecruiting
  • RigshospitaletRecruiting
  • Aalborg University HospitalRecruiting
  • Odense University HospitalRecruiting
  • Roskilde SygehusRecruiting
  • Vejle SygehusRecruiting
  • Århus University HospitalRecruiting
  • Groupe Hospitalier Pitie-SalpetriereRecruiting
  • CHU de Nancy - Hôpital de Brabois AdultesRecruiting
  • Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-KrebscentrumRecruiting
  • Universitaetsklinikum KoelnRecruiting
  • Amsterdam UMCRecruiting
  • Universitair Medisch Centrum GroningenRecruiting
  • Hospital Universitario Ramón y CajalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.

Only in expansion phase.

In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.

Only in expansion phase.

Only in expansion phase.

Outcomes

Primary Outcome Measures

Dose Escalation Phase (R/R CLL arm): Number of Participants with Dose Limiting Toxicities (DLTs)
DLT events were defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
Dose Escalation Phase: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Dose Escalation Phase: Number of Participants with Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Clinical Tumor Lysis Syndrome (CTLS)
CRS and ICANS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria. CTLS will be graded according to Cairo-Bishop criteria.
Expansion Phase: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve a response of partial response or complete response, prior to initiation of subsequent therapy. R/R CLL participants will be assessed according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and the RS participants according to Lugano criteria.

Secondary Outcome Measures

Expansion Phase: Number of Participants with TEAEs and SAEs
Dose Escalation Phase: ORR
ORR is defined as percentage of participants who achieve a response of partial response or complete response, prior to initiation of subsequent therapy as assessed by iwCLL criteria.
Both Phases: Duration of Response (DOR)
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Both Phases: Number of Participants with Complete Remission (CR) / CR with Incomplete Bone Marrow Recovery (CRi)
CR and CRi for R/R CLL participants will be assessed according to iwCLL criteria and CR for the RS participants, according to Lugano criteria.
Both Phases: Time to Response (TTR)
TTR is defined among responders, as the time between first dose of epcoritamab and the initial documentation of response.
Both Phases: Progression Free Survival (PFS)
PFS is defined as the time from the first dosing date of epcoritamab and the date of disease progression or death, whichever occurs earlier.
Both Phases: Overall Survival (OS)
OS is defined as the time from the first dosing date of epcoritamab and the date of death due to any cause.
Both Phases: Time to Next Systemic Anti-cancer Therapy (TTNT)
TTNT is defined as the time from the first dosing date of epcoritamab to the first documented administration of subsequent systemic anticancer therapy.
Both Phases: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) in Epcoritamab
Both Phases: AUC From Time Zero to Infinity (AUCinf) in Epcoritamab
Both Phases: Maximum (Peak) Plasma Concentration (Cmax) in Epcoritamab
Both Phases: Pre-dose (Trough) Concentrations (Cthrough) in Epcoritamab
Both Phases: Time to Reach Cmax (Tmax) in Epcoritamab
Both Phases: Elimination Half-life (T1/2) in Epcoritamab
Both Phases: Total Body Clearance of Drug From Plasma (CL) in Epcoritamab
Both Phases: Volume of distribution (Vd) in Epcoritamab
Both Phases: Lymphoid Cells for Immunophenotyping
Evaluation of B cells, T cells and their activation
Expansion Phase: Number of Participants with CRS, ICANS and CTLS
CRS and ICANS will be graded based on ASTCT criteria. CTLS will be graded according to Cairo-Bishop criteria.
Expansion Phase: Percentage of Participants with Minimal Residual Disease (MRD) Negativity
MRD negativity rate, is defined as the proportion of participants with at least 1 undetectable MRD result according to the specific threshold, prior to initiation of subsequent therapy.
Both Phases: Number of Participants with Anti-drug Antibodies (ADA) to Epcoritamab
Expansion Phase: Number of Participants with Partial Remission (PR)/Nodular Partial Remission (nPR)
nPR is defined as PR with residual nodules or suspicious lymphocytic infiltrates in participants who are in remission. nPR is only calculated for R/R CLL.
Both Phases: Duration of MRD Negativity
The time from first achieving MRD negativity after start of treatment to the MRD conversion to positive.

Full Information

First Posted
October 27, 2020
Last Updated
August 7, 2023
Sponsor
Genmab
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04623541
Brief Title
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Acronym
EPCORE™ CLL-1
Official Title
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
June 2029 (Anticipated)
Study Completion Date
August 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: Monotherapy, or Combination therapy: epcoritamab + venetoclax epcoritamab + lenalidomide epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase.
Detailed Description
The purpose of the dose-escalation phase of the trial is to determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD; if reached) as well as establish the safety profile of epcoritamab monotherapy and epcoritamab + venetoclax in participants with R/R CLL. The purpose of the expansion phase is to assess and evaluate the preliminary efficacy, safety and tolerability profiles of epcoritamab monotherapy and epcoritamab + venetoclax at the RP2D for patients with R/R CLL/SLL. Along with this, epcoritamab monotherapy, epcoritamab + lenalidomide and epcoritamab + R-CHOP will be evaluated in patients with RS to assess their efficacy, safety and tolerability profiles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome
Keywords
DuoBody®, Bispecific antibodies, Anti-CD3, Anti-CD20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epcoritamab in R/R CLL/SLL
Arm Type
Experimental
Arm Description
In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.
Arm Title
Epcoritamab in RS
Arm Type
Experimental
Arm Description
Only in expansion phase.
Arm Title
Epcoritamab + Venetoclax in R/R CLL/SLL
Arm Type
Experimental
Arm Description
In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.
Arm Title
Epcoritamab + Lenalidomide in RS
Arm Type
Experimental
Arm Description
Only in expansion phase.
Arm Title
Epcoritamab + R-CHOP in RS
Arm Type
Experimental
Arm Description
Only in expansion phase.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Intervention Description
Epcoritamab will be administered subcutaneously in cycles of 28 days (except Cycle 1 for high-dose cohorts = 35 days).
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Intervention Description
Epcoritamab will be administered subcutaneously in cycles of 21 days (Cycle 1-6) and 28 days for Cycle 7 and beyond.
Intervention Type
Drug
Intervention Name(s)
rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
Intervention Description
R-CHOP will be administered intravenously in cycles of 21 days for the first 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Intervention Description
Venetoclax tablets will be administered orally once daily during the 5-week ramp up period and during Cycle 1-26 of 28 or 35 days each.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Intervention Description
Epcoritamab will be administered subcutaneously in cycles of 28 days.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide capsules will be administered once daily for 21 days in each cycle of 28 days up to 12 cycles.
Primary Outcome Measure Information:
Title
Dose Escalation Phase (R/R CLL arm): Number of Participants with Dose Limiting Toxicities (DLTs)
Description
DLT events were defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
Time Frame
During the first cycle for low dose cohorts (Cycle length = 28 days) and for high dose cohorts (Cycle length = 35 days)
Title
Dose Escalation Phase: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
From first dose until the end of the safety follow-up period (60 days after last dose)
Title
Dose Escalation Phase: Number of Participants with Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Clinical Tumor Lysis Syndrome (CTLS)
Description
CRS and ICANS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria. CTLS will be graded according to Cairo-Bishop criteria.
Time Frame
From first dose until the end of the safety follow-up period (60 days after last dose)
Title
Expansion Phase: Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieve a response of partial response or complete response, prior to initiation of subsequent therapy. R/R CLL participants will be assessed according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and the RS participants according to Lugano criteria.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Expansion Phase: Number of Participants with TEAEs and SAEs
Time Frame
From first dose until the end of the safety follow-up period (60 days after last dose)
Title
Dose Escalation Phase: ORR
Description
ORR is defined as percentage of participants who achieve a response of partial response or complete response, prior to initiation of subsequent therapy as assessed by iwCLL criteria.
Time Frame
Up to 5 years
Title
Both Phases: Duration of Response (DOR)
Description
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Time Frame
Up to 5 years
Title
Both Phases: Number of Participants with Complete Remission (CR) / CR with Incomplete Bone Marrow Recovery (CRi)
Description
CR and CRi for R/R CLL participants will be assessed according to iwCLL criteria and CR for the RS participants, according to Lugano criteria.
Time Frame
Up to 5 years
Title
Both Phases: Time to Response (TTR)
Description
TTR is defined among responders, as the time between first dose of epcoritamab and the initial documentation of response.
Time Frame
Up to 5 years
Title
Both Phases: Progression Free Survival (PFS)
Description
PFS is defined as the time from the first dosing date of epcoritamab and the date of disease progression or death, whichever occurs earlier.
Time Frame
Up to 5 years
Title
Both Phases: Overall Survival (OS)
Description
OS is defined as the time from the first dosing date of epcoritamab and the date of death due to any cause.
Time Frame
Up to 5 years
Title
Both Phases: Time to Next Systemic Anti-cancer Therapy (TTNT)
Description
TTNT is defined as the time from the first dosing date of epcoritamab to the first documented administration of subsequent systemic anticancer therapy.
Time Frame
Up to 5 years
Title
Both Phases: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: AUC From Time Zero to Infinity (AUCinf) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: Maximum (Peak) Plasma Concentration (Cmax) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: Pre-dose (Trough) Concentrations (Cthrough) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: Time to Reach Cmax (Tmax) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: Elimination Half-life (T1/2) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: Total Body Clearance of Drug From Plasma (CL) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: Volume of distribution (Vd) in Epcoritamab
Time Frame
Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
Title
Both Phases: Lymphoid Cells for Immunophenotyping
Description
Evaluation of B cells, T cells and their activation
Time Frame
Up to 5 years
Title
Expansion Phase: Number of Participants with CRS, ICANS and CTLS
Description
CRS and ICANS will be graded based on ASTCT criteria. CTLS will be graded according to Cairo-Bishop criteria.
Time Frame
From first dose until the end of the safety follow-up period (60 days after last dose)
Title
Expansion Phase: Percentage of Participants with Minimal Residual Disease (MRD) Negativity
Description
MRD negativity rate, is defined as the proportion of participants with at least 1 undetectable MRD result according to the specific threshold, prior to initiation of subsequent therapy.
Time Frame
Up to 5 years
Title
Both Phases: Number of Participants with Anti-drug Antibodies (ADA) to Epcoritamab
Time Frame
Up to end of treatment period (Up to 2 years)
Title
Expansion Phase: Number of Participants with Partial Remission (PR)/Nodular Partial Remission (nPR)
Description
nPR is defined as PR with residual nodules or suspicious lymphocytic infiltrates in participants who are in remission. nPR is only calculated for R/R CLL.
Time Frame
Up to 5 years
Title
Both Phases: Duration of MRD Negativity
Description
The time from first achieving MRD negativity after start of treatment to the MRD conversion to positive.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. Evidence of CD20 positivity in a sample representative of the disease at Screening. Acceptable hematology parameters and organ function based on baseline bloodwork. For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria. For R/R CLL arms - Received at least 2 prior lines of systemic anti-neoplastic therapy including a Bruton's tyrosine kinase (BTK) inhibitor. For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL. For all RS arms - Must have measurable disease by fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) or magnetic resonance imaging (MRI) scan. For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample. Life expectancy >3 months on standard of care (SOC). For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy For RS - lenalidomide combination therapy arm Deemed as ineligible for chemoimmunotherapy at the investigator's discretion, or participant who refuses to receive intensive chemotherapy. Eligible for treatment with lenalidomide. Must be willing to use contraception and adhere to the Lenalidomide Pregnancy Risk Minimization Plan For RS - R-CHOP combination Therapy Arm - Eligible for treatment with R-CHOP. For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy. Key Exclusion Criteria Received prior treatment with a CD3×CD20 bispecific antibody. Received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. Received (CAR) T-cell therapy within 100 days or an investigational drug within 4 weeks, prior to first dose of epcoritamab. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy. Received vaccination with live vaccines within 28 days. Clinically significant cardiac disease. Known current malignancy other than inclusion diagnosis. Has had major surgery within 4 weeks. Active hepatitis B virus or active hepatitis C. Known history of HIV. For R/R CLL arms - Any history of RS or evidence indicating a potential Richter's transformation. Received venetoclax within 24 months prior to beginning venetoclax ramp-up for this trial and progressed on treatment. For all RS arms - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia. RS - Lenalidomide Combination Therapy and RS Monotherapy Arms - received more than 2 prior lines of therapy for RS. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Genmab Trial Information
Phone
+4570202728
Email
clinicaltrials@genmab.com
Facility Information:
Facility Name
University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48190
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Group
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack Meridian Hospital
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Southwestern Medical Centre
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospital of Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
København
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Roskilde Sygehus
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Århus University Hospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nancy - Hôpital de Brabois Adultes
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Amsterdam UMC
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

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