Study of Epcoritamab as a Consolidation Therapy in CLL/SLL

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Zulfa Omer
Study ID
NCT07108998
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    Epcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period.

Study Details

This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +/- Obinutuzumab in CLL/SLL patients or patients with variants of this.

Key Dates

Start date
Aug 22, 2025
Status verified
Jan 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Epcoritamab + SOC
    Epcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period.

Primary Outcome Measure

uMRD CR as defined by negative leukemia cells to the 10^6 [ Time Frame: Post 12 cycles (approximately 336 days after the start of first cycle) of consolidative therapy with epcoritamab ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45219
Christine Vollmer
[email protected]
5132133203
Zulfa Omer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Cincinnati· Cincinnati, OH

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