A Study of Lonitoclax (ZE50-0134) in Relapsed or Refractory B-cell Malignancies
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This Phase 1, open-label, multicenter study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of lonitoclax (ZE50-0134) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and select low-grade B-cell lymphomas. The study has two sequential parts. Part 1 uses dose escalation to determine the biologically effective dose and/or maximum tolerated dose of lonitoclax. Participants receive a 3-day step-up regimen followed by continuous once-daily or twice-daily oral dosing in 28-day cycles. Part 2 is a randomized dose-expansion comparison of two selected lonitoclax dose levels in venetoclax-naive participants with relapsed or refractory CLL/SLL. Treatment may continue for up to 12 cycles and, for participants deriving clinical benefit, for up to 24 cycles with approval from the Medical Monitor.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety i mężczyźni w wieku 18 lat i starsi.
- •Osoby z nawracającą lub oporną na leczenie przewlekłą białaczką limfocytową (CLL) lub chłoniakiem limfocytowym małych komórek (SLL), które wcześniej były leczone innymi lekami.
- •Osoby z niektórymi rodzajami chłoniaków o powolnym wzroście, które były wcześniej leczone.
- •Choroba wymaga leczenia według oceny lekarza prowadzącego badanie.
- •Dobre wyniki badań krwi wskazujące na prawidłowe funkcjonowanie szpiku kostnego, wątroby i nerek.
- •Ogólny stan zdrowia pozwalający na udział w badaniu (skala ECOG 0, 1 lub 2).
- •Kobiety w wieku rozrodczym muszą mieć negatywny test ciążowy przed rozpoczęciem leczenia i przed każdym kolejnym cyklem leczenia.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 31, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (5)
Norton Cancer Institute, St. Matthews Campus
Louisville, United States
University of North Carolina at Chapel Hill
Chapel Hill, United States
University of Cincinnati
Cincinnati, United States
The Ohio State University
Columbus, United States
UT Southwestern Medical Center
Dallas, United States
Trial contact
Ekaterina Dokukina, PhD MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
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