Actively Recruiting
A 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
Led by Zulfa Omer · Updated on 2025-08-14
34
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
Z
Zulfa Omer
Lead Sponsor
N
Newave Pharmaceutical Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of LP-168 and obinutuzumab for patients with previously treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and those with a specific BTK T474I gatekeeper mutation. This phase II multicenter study aims to find a safe dosing plan and gather early data on how well the combination works to increase deep response rates, including complete remission and undetectable minimal residual disease (MRD). Participants will receive LP-168 orally at 200 mg daily starting from day 1 for 12 cycles, each cycle lasting 28 days. After cycle 6, response will be evaluated by labs, CT scans, and bone marrow biopsy. Starting cycle 7, obinutuzumab is added for 6 cycles alongside LP-168, administered on specific days within each cycle. At the end of cycle 12, therapy will be assessed, and patients with undetectable MRD and complete remission may stop treatment; others may continue LP-168 with follow-up every 6 months. During the study, patients undergo regular assessments including labs, imaging, bone marrow exams, and next-generation sequencing to monitor MRD status. Researchers will measure response rates, safety, drug pharmacokinetics, and BTK occupancy. Follow-up for response duration, survival, and safety will continue for up to six years, ensuring detailed monitoring of treatment effects and patient outcomes over time.
CONDITIONS
Brief Title
LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CLL or SLL meeting 2018 iwCLL criteria and requiring treatment
- Eligible for one of two cohorts: Cohort 1 with one or more prior therapies including BCL2 inhibitor, chemotherapy, or BTK inhibitors; Cohort 2 with prior BTKi treatment and BTK T474 gatekeeper mutation
- Age 18 years or older
- ECOG performance status 0 to 2 (or Karnofsky 60% or higher)
- Adequate organ and marrow function as defined by specific lab values
- Use of effective birth control for women of childbearing potential and non-sterile males
- Negative pregnancy test for women of childbearing potential
- Able to provide informed consent
You will not qualify if you...
- Active Richter's transformation
- Recent anti-cancer or investigational therapy within 14 days or 5 half-lives, with exceptions for short-term steroids for disease control
- Uncontrolled intercurrent illness or significant conditions increasing risk
- Requirement for warfarin or equivalent anticoagulation
- Major surgery within 14 days prior to study drug
- Use of certain medications including strong CYP3A4 inducers or inhibitors within 14 days
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to study drug
- Use of systemic acid-reducing agents unless managed per protocol
- Significant ECG abnormalities or serious cardiovascular disease
- History of stroke or intracranial hemorrhage within 180 days
- Recent hematopoietic stem cell transplantation or active graft-versus-host disease
- Pregnancy or breastfeeding
- Significant gastrointestinal diseases affecting absorption
- Known hypersensitivity to LP-168 components
- Active bleeding disorders unless controlled
- Uncontrolled infections or active hepatitis B or C
- Recent other active malignancies except specified exceptions
- Active CNS involvement with significant symptoms requiring high dose steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 cycles (approximately 336 days)
Participants receive daily LP-168 for 12 cycles (each cycle is 28 days). Obinutuzumab is added starting cycle 7 for 6 cycles with specific doses on days 1, 2, 8, and 15 of cycle 7 and day 1 of cycles 8 to 12. Response evaluations including labs, CT scans, and bone marrow biopsy occur within 2 weeks after cycle 6 and at the end of cycle 12.
Regular visits during 12 cycles including a response evaluation visit within 2 weeks after cycle 6 and at end of cycle 12
Duration - Ongoing every 6 months after treatment
Participants with less than complete remission or detectable minimal residual disease may continue LP-168 therapy with follow-up visits every 6 months. MRD testing may be repeated during the disease course to determine if therapy can be stopped. Participants with disease progression but benefiting from treatment may continue per investigator discretion.
Follow-up visits every 6 months
Trial Site Locations
Total: 1 location
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
U
UCCC Clinical Trials Office
Z
Zulf Omer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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