Clin2
NCT04775745Possibly a fitRecruiting

Oral drug test for relapsed or refractory B-cell blood cancers

CLL/SLLWaldenstrom MacroglobulinemiaFollicular LymphomaDiffuse Large B Cell LymphomaMantle Cell LymphomaMarginal Zone LymphomaHairy Cell Leukemia

Treatments studied

Part of Blood & lymphatic, Cancer, Heart & circulation, Immune system & allergy clinical trials.

This Phase 1 trial studies LP-168 taken by mouth in people whose B-cell cancers have come back or did not respond to treatment. The study aims to find how the drug works, the right dose, and what side effects to expect.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
60 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have a B-cell cancer such as Waldenström’s macroglobulinemia, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, DLBCL, hairy cell leukemia, chronic lymphocytic leukemia, or small lymphocytic lymphoma (based on 2016 WHO type).
  • If your diagnosis is Waldenström’s, follicular (FL), mantle cell (MCL), DLBCL, or hairy cell leukemia (HCL), you must have already had at least 2 prior cancer treatments.
  • Your blood tests and organ function must be adequate: kidney function (creatinine clearance ≥ 60 mL/min), liver enzymes (AST/ALT) and bilirubin (mostly ≤ 1.5× normal), and clotting tests (PT and APTT ≤ 1.5× normal).
  • Your bone marrow must make enough cells: neutrophils (ANC) at least 1000 (sometimes growth factor can help), platelets at least 50,000 (or 20,000 in certain CLL cases), and hemoglobin at least 8.0 (blood transfusion is allowed to reach this).
  • You must not have had anti-cancer treatment, radiation, or other investigational drugs within 14 days (or 5 half-lives, whichever is shorter) before starting LP-168, and you must be back to low-grade side effects (except hair loss).
  • You must be able to avoid certain medicines: strong acid medicines (PPIs must be stopped 7 days before and during the study), and avoid specific liver-enzyme–affecting drugs and Warfarin; also avoid major heart rhythm problems on ECG (QTc ≥ 480ms or certain blocks).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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