Study Summary
This trial is testing a new drug, epcoritamab, to see if it is safe and effective in treating B-cell Non-Hodgkin Lymphoma.
Eligible Conditions
- Follicular Lymphoma
- Non-Hodgkin's Lymphoma
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
11 Primary · 48 Secondary · Reporting Duration: From 6 weeks after enrollment until treatment discontinuation, assessed up to 3 years
Year 3
Residual Tumor
Duration of response (DOR)
Overall survival (OS)
Progressive-free survival (PFS)
Rate of minimal residual disease (MRD) negativity
Time to next anti-lymphoma therapy (TTNT)
Time to response (TTR)
Year 3
Safety run-in only: preliminary anti-tumor activity as measured by the overall response rate
Day 28
Dose Escalation Phase - Number of dose-limiting toxicities (DLTs)
Day 28
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
Day 28
Part 1: DLTs
Year 3
Part 2: Overall Response Rate (ORR)
Year 3
Area Under the Concentration-Time Curve (AUC) from Time 0 to infinity
Area Under the Concentration-Time Curve (AUC) from Time 0 to last quantifiable sample
Maximum observed concentration (Cmax)
Terminal Elimination Half-Life (t 1/2)
Time to reach Cmax (Tmax)
Total body clearance of drug from the plasma (CL)
Trough concentrations (Ctrough)
Volume of Distribution
Day 30
Part 1 and Part 2: Incidence of adverse events
Day 60
Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs)
Month 24
Incidence of anti-drug antibodies (ADAs) to epcoritamab
Part 1 and Part 2: Incidence of dose interruptions and delays
Day 60
Dose Escalation Phase - Number of Adverse Events
Month 24
Part 1 and Part 2: Incidence and severity of changes in laboratory values
Year 3
Pharmacokinetics concentration of epcoritamab
Month 24
Incidence of anti-drug antibodies (ADAs) to Epcoritamab
Year 3
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab
Part 1 and 2: Clearance (CL) of Epcoritamab
Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab
Part 1 and 2: Plasma Trough (Pre-dose) Concentrations (Ctrough) of Epcoritamab
Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab
Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab
Part 1 and 2: Volume of Distribution (Vd) of Epcoritamab
Up to 2 years
Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years)
Part 1 and 2: Number of Immune Cell Populations
Part 1 and 2: Percentage of Immune Cell Populations
Up to 3 years
Part 1 and 2: Duration of Complete Response (DoCR)
Part 1 and 2: Duration of Response (DOR)
Part 1 and 2: Duration of minimal residual disease (MRD) negativity
Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab
Part 1 and 2: Overall Survival (OS)
Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
Part 1 and 2: Progression Free Survival (PFS)
Part 1 and 2: Time to Complete Response (TTCR)
Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT)
Part 1 and 2: Time to Response (TTR)
Part 1: ORR
Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity
Part 2 (Except Arm 7): Overall Response Rate (ORR)
Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10
Day 56
Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3
Year 3
Expansion Part - Preliminary anti-tumor activity
Up to safety follow-up (up to 60days after last dose)
Expansion only: Monitor number and severity of AEs
Expansion only: Monitor number and severity of changes in laboratory values
Expansion only: Monitor number of dose interruptions and delays
Week 96
Part 2 (Arm 7): Percentage of Participants With CR
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Trial Design
12 Treatment Groups
Arm 10 - Epcoritamab + R-ICE
1 of 12
Arm 9 - Epcoritamab + Lenalidomide
1 of 12
Arm 6 - Epcoritamab + R- Lenalidomide
1 of 12
Arm 2 - Epcoritamab + R- Lenalidomide
1 of 12
Arm 1 - Epcoritamab + R-CHOP
1 of 12
Arm 2 - Epcoritamab + R2
1 of 12
Arm 3 - Epcoritamab + BR
1 of 12
Arm 4 - Epcoritamab + R-DHAX/C
1 of 12
Arm 5 - Epcoritamab + GemOx
1 of 12
Arm 6 - Epcoritamab + R2
1 of 12
Arm 7 - Epcoritamab maintenance
1 of 12
Arm 8 - Epcoritamab + R mini-CHOP
1 of 12
Experimental Treatment
662 Total Participants · 12 Treatment Groups
Primary Treatment: rituximab and lenalidomide · No Placebo Group · Phase 1 & 2
Arm 10 - Epcoritamab + R-ICEExperimental Group · 2 Interventions: rituximab, ifosfamide, carboplatin, and etoposide phosphate, Epcoritamab · Intervention Types: Drug, Biological
Arm 9 - Epcoritamab + LenalidomideExperimental Group · 2 Interventions: Lenalidomide, Epcoritamab · Intervention Types: Drug, Biological
Arm 6 - Epcoritamab + R- LenalidomideExperimental Group · 2 Interventions: rituximab and lenalidomide, Epcoritamab · Intervention Types: Drug, Biological
Arm 2 - Epcoritamab + R- LenalidomideExperimental Group · 2 Interventions: rituximab and lenalidomide, Epcoritamab · Intervention Types: Drug, Biological
Arm 1 - Epcoritamab + R-CHOPExperimental Group · 2 Interventions: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, Epcoritamab · Intervention Types: Drug, Biological
Arm 2 - Epcoritamab + R2Experimental Group · 2 Interventions: rituximab and lenalidomide, Epcoritamab · Intervention Types: Drug, Biological
Arm 3 - Epcoritamab + BRExperimental Group · 2 Interventions: rituximab and bendamustine, Epcoritamab · Intervention Types: Drug, Biological
Arm 4 - Epcoritamab + R-DHAX/CExperimental Group · 2 Interventions: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin, Epcoritamab · Intervention Types: Drug, Biological
Arm 5 - Epcoritamab + GemOxExperimental Group · 2 Interventions: gemcitabine and oxaliplatin, Epcoritamab · Intervention Types: Drug, Biological
Arm 6 - Epcoritamab + R2Experimental Group · 2 Interventions: rituximab and lenalidomide, Epcoritamab · Intervention Types: Drug, Biological
Arm 7 - Epcoritamab maintenanceExperimental Group · 2 Interventions: Epcoritamab, Epcoritamab Maintenance · Intervention Types: Biological, Biological
Arm 8 - Epcoritamab + R mini-CHOPExperimental Group · 2 Interventions: Epcoritamab, rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1220
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from 6 weeks after enrollment until treatment discontinuation, assessed up to 3 years
Who is running the clinical trial?
GenmabLead Sponsor
51 Previous Clinical Trials
9,632 Total Patients Enrolled
AbbVieIndustry Sponsor
871 Previous Clinical Trials
478,545 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a type of lymphoma called DLBCL that has come back or is not responding to treatment and you cannot receive high-dose chemotherapy with stem cell transplant.
You have a specific type and stage of lymphoma called FL Grade 1-3A.
References
- Falchi L, Offner F, Belada D, Brody J, Linton KM, Karimi Y, Cordoba R, Snauwaert S, Abbas A, Wang L, Wu J, Elliott B, Clausen MR. ABCL-452 First-Line Treatment With Subcutaneous Epcoritamab + R-CHOP in Patients With High-Risk Diffuse Large B-Cell Lymphoma (DLBCL): Phase 1/2 Data Update. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S380. doi: 10.1016/S2152-2650(22)01542-7.
- Brody J, Wahlin BE, Phillips T, Costello R, Lugtenburg P, Cordoba R, Wang L, Wu J, Elliott B, Abbas A, J Rgensen J. ABCL-439 Subcutaneous Epcoritamab With Gemcitabine + Oxaliplatin (GemOx) Induced High Response Rates in Patients With Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Autologous Stem Cell Transplant (ASCT). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S379-S380. doi: 10.1016/S2152-2650(22)01541-5.
- Falchi L, Leppä S, Wahlin BE, Nijland M, Christensen JH, de Vos S, Holte H, Linton KM, Abbas A, Wang L, Dinh M, Elliott B, Belada D. IBCL-460 Subcutaneous Epcoritamab With Rituximab + Lenalidomide (R(2)) in Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Update from Phase 1/2 Trial. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S392. doi: 10.1016/S2152-2650(22)01565-8.
- 2020. "Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04663347.
Frequently Asked Questions
How many participants have been recruited for this clinical trial?
"The AbbVie-sponsored study requires 396 qualified participants, and will be conducted at the John Theurer Cancer Center in Hackensack, New Jersey as well as UMPC Hillman Cancer Center in Pittsburgh, Pennsylvania." - Anonymous Online Contributor
Unverified Answer
Are there still vacancies in this clinical trial?
"According to clinicaltrials.gov, the current state of affairs shows that this trial is actively seeking participants; it was first posted on November 16th 2020 and edited most recently on April 13th 2022." - Anonymous Online Contributor
Unverified Answer
How many centers are conducting this research trial?
"Patients interested in participating can find locations for this clinical trial at the John Theurer Cancer Center, Hackensack UMC (Hackensack NJ), UMPC Hillman Cancer Center cancer Pavillion (Pittsburgh PA) and Dana Farber Cancer Institute (Boston MA). 10 other sites are also available." - Anonymous Online Contributor
Unverified Answer
What medical conditions are commonly addressed with rituximab and lenalidomide?
"Rituximab and lenalidomide are typically used to treat macular edema, as well as pheochromocytomas, ocular conditions, and ulcerative colitis." - Anonymous Online Contributor
Unverified Answer
Are there any prior investigations that have combined rituximab and lenalidomide?
"Rituximab and lenalidomide were first studied at the NIH Clinical Centre on Rockville Pike back in 1993. To date, there have been 5624 studies that have concluded with 3255 presently ongoing; a substantial amount of these trials are taking place out of Hackensack, New Jersey." - Anonymous Online Contributor
Unverified Answer