Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06978088

LP-168 and Obinutuzumab for 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

469 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of CLL or SLL meeting 2018 iwCLL criteria and requiring treatment
  • Patients with variant flow cytometry but supportive cytogenetics or mutational studies for CLL/SLL
  • Eligible for one of two cohorts: (1) prior therapies including BCL2i, chemotherapy, or BTKi; (2) prior BTKi treatment with BTK T474 gatekeeper mutation
  • Age 18 years or older
  • ECOG performance status 0 to 2 or Karnofsky score 60% or higher
  • Adequate organ and marrow function with ANC 2000/mcL or higher (unless due to CLL), platelets 20,000/mcL or higher (unless due to CLL), bilirubin 1.5 x ULN (except Gilbert's syndrome), AST and ALT 2.5 x ULN, and kidney function with GFR 30 mL/min or higher
  • Women of childbearing potential and non-sterile men must use effective birth control throughout the study and for 30 days after
  • Negative pregnancy test for women of childbearing potential before starting treatment
  • Non-sterile males must avoid sperm donation until 30 days after last dose
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Active Richter's transformation
  • Recent anti-cancer, investigational, or immunotherapy within 14 days or 5 half-lives prior to treatment
  • Uncontrolled illness or significant conditions making participation unsafe
  • Need for warfarin or equivalent anti-coagulation
  • Major surgery within 14 days prior to treatment
  • Recent use of high-dose steroids, CYP3A4 or CYP2C8 inhibitors/inducers, or certain other medications
  • Consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to treatment
  • Requirement for systemic acid-reducing agents not compliant with study guidelines
  • Significant ECG abnormalities or serious heart conditions
  • Stroke or intracranial hemorrhage within 180 days prior to treatment
  • Recent hematopoietic stem cell transplant or active graft-versus-host disease
  • Pregnancy or breastfeeding
  • Known gastrointestinal malabsorption or serious bowel diseases
  • Known hypersensitivity to LP-168 components
  • Active bleeding disorders unless well controlled
  • Active uncontrolled infections or poorly controlled HIV or hepatitis B/C
  • Fever above 38.3 0C without explained cause
  • Other active malignancies within 1 year except certain stable or treated cancers
  • Patients with active CNS involvement with significant symptoms requiring high-dose steroids are excluded

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

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Research Team

U

UCCC Clinical Trials Office

CONTACT

Z

Zulf Omer, MD

CONTACT

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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