LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Zulfa Omer
Study ID
NCT06978088
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • LP-168 — DRUG
    Patients will receive LP-168 200 mg daily beginning day 1 of therapy for 12 cycles.
  • Obinutuzumab — DRUG
    Patients will with LP-168 and then receive obinutuzumab for a total of 6 cycles, beginning cycle 7, days 1, 2, 8 and 15, and then day 1 of cycles 8-12. A minimum of 12 cycles of therapy will be administered.

Study Details

Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This.

Key Dates

Start date
Jun 1, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2029
Completion
Jun 1, 2034

Study Design

Enrollment
34 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Cohort 1: One or more prior therapies for CLL/SLL including BCL2 inhibitor (BCL2i), and/or chemotherapy and/or BTK inhibitor (BTKi). • Note: Patients can be eligible if their CLL/SLL has been non-responsive to a covalent and noncovalent BTKi. Patients intolerant to BTKi whose disease becomes resistant to a second one are eligible to enroll. Prior treatment with CD20 will not be exclusionary.
  • Experimental: Cohort 2
    Cohort 2: Treatment with a prior BTKi (covalent and noncovalent) and have a BTK gatekeeper mutation in the T474 coordinate. prior treatment with BCL2 or chemotherapy will not exclude patients

Primary Outcome Measure

Complete remission/ Complete remission with incomplete count (CR/CRi) defined by the IWCLL 2018 criteria [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati Medical CenterCincinnatiOhio45219
UCCC CTO
[email protected]
513-584-7698
Christine Vollmer
[email protected]
Zulfa Omer, MD (PRINCIPAL_INVESTIGATOR)

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