M20-621: A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with R-CHOP compared to R-CHOP in Subjects with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
III
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
(410) 955-8964Brief Summary
This is an open-label, 2:1 randomized, global, multi-center, Phase 3 study to evaluate the safety and efficacy of the combination of epcoritamab + R-CHOP compared to R-CHOP alone in subjects with newly diagnosed DLBCL primarily with an IPI of 3-5 and subsequently with an IPI of 2-5. Eligible subjects will be randomized 2:1 to receive either 6 cycles of epcoritamab in combination with 6 cycles of R-CHOP followed by 2 cycles of epcoritamab alone (E + R-CHOP, investigational arm), or standard 6 cycles of R-CHOP followed by 2 cycles of rituximab alone (R-CHOP, control arm). R-CHOP (Investigational and Control Arms): Rituximab: 375 mg/m2 Cyclophosphamide: 750 mg/m2 Doxorubicin HCL: 50 mg/m2 Vincristine: 1.4 mg/m2 (maximum of 2 mg) Prednisone: 100 mg Epcoritamab (Investigational Arm): Administered at a priming dose of 0.16 mg dose, an intermediate dose of 0.8 mg, followed by full doses of 48 mg.
Eligibility
-Age >/= 18 years old and < 80 years old with a life expectancy of >/=12 months.