The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.
The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
This is a multi-center, randomized, double-blinded, placebo controlled trial.
About the trial
This phase I/II trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rozpoznana białaczka szpikowa (AML) lub zespół mielodysplastyczny z dużym udziałem zmienonych komórek
- •Dla pacjentów bez wcześniejszego leczenia: wiek co najmniej 60 lat, nienadający się do intensywnej chemioterapii
- •Dla pacjentów po nawrocie choroby: wiek co najmniej 18 lat
- •Pacjenci poniżej 75 lat z poważnymi problemami sercowymi lub oddechowymi mogą się kwalifikować
- •Pacjenci z nowo rozpoznaną białaczką o złym rokowaniu, niezależnie od wieku (do 60 lat)
✗ Disqualifies
- •Ostry białaczka promieloblastyczna (specjalny typ białaczki)
- •Ciężkie problemy z pracą serca (fraction wyrzutowa poniżej 50%)
- •Poważne problemy z funkcją płuc
- •Ciężkie uszkodzenie wątroby (enzymy powyżej 3 razy normy)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 21, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
M D Anderson Cancer Center
Houston, United States
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.
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