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iwCLL 2025 | MRD-driven venetoclax plus rituximab in previously untreated CLL: the VERITA-PALG-CLL5 trial

Krzysztof Jamroziak, MD, PhD, Medical University of Warsaw, Warsaw, Poland, presents the results of the Phase II VERITA-PALG-CLL5 trial (EudraCT: 2019-004613-14), which is investigating a measurable residual disease (MRD)-driven venetoclax and rituximab combination strategy in patients with previously untreated chronic lymphocytic leukemia (CLL). Dr Jamroziak highlights the encouraging results of this study to date, which indicate that tailoring treatment duration based on MRD status is feasible in this patient population. This interview took place at the biennial International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2025 in Krakow, Poland.

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Transcript

So the VERITA trial is a Phase II clinical study by the Polish Adult Leukemia Group. It has investigated the combination of venetoclax with rituximab given for the maximum of 24 months in the first-line CLL setting. The rituximab was given monthly for the first six months and then bimonthly until the end of treatment, and the patients who achieved undetectable MRD and complete remission after 12 or 18 cycles discontinued treatment by the protocol...

So the VERITA trial is a Phase II clinical study by the Polish Adult Leukemia Group. It has investigated the combination of venetoclax with rituximab given for the maximum of 24 months in the first-line CLL setting. The rituximab was given monthly for the first six months and then bimonthly until the end of treatment, and the patients who achieved undetectable MRD and complete remission after 12 or 18 cycles discontinued treatment by the protocol. 

And now these are not the final results. Some patients still continue therapy, but most of them finished. And we saw a high rate of undetectable MRD after 12 cycles, and including more than 90% of patients had undetectable MRD in the bone marrow, but 44% had undetectable MRD plus complete remission, and those discontinued. And at the second time point, after 18 months, additional patients also achieved undetectable MRD and CR, and they also discontinued. And this second proportion was smaller, which is a normal pattern in such MRD-driven studies. So, by these results, we think that we can tailor the treatment duration to MRD status. The treatment was very safe, but it should be confirmed in the Phase III trial.

 

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Disclosures

Research Support: AbbVie, Janssen, GSK.