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Evaluating the risk of tumor lysis syndrome in adults with chronic lymphocytic leukemia receiving venetoclax with obinutuzumab or acalabrutinib

A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL

Phase 3 Interventional AbbVie · NCT06428019

This study is testing if the combination of venetoclax with either obinutuzumab or acalabrutinib is safe for adults with untreated chronic lymphocytic leukemia.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsobinutuzumab, acalabrutinib
Locations70 sites (Tucson, Arizona and 69 other locations)
Trial IDNCT06428019 on ClinicalTrials.gov

What this trial studies

This study investigates the safety of venetoclax when combined with either obinutuzumab or acalabrutinib in adults with previously untreated chronic lymphocytic leukemia (CLL). Participants will be assigned to one of four treatment arms, receiving either oral venetoclax with IV obinutuzumab or oral acalabrutinib, with a specific dosing schedule. The study aims to assess adverse events and changes in disease activity among approximately 120 participants across 80 sites worldwide.

Who should consider this trial

Good fit: Ideal candidates are adults with previously untreated chronic lymphocytic leukemia requiring treatment and a life expectancy of more than 6 months.

Not a fit: Patients with active or uncontrolled infections or those with Richter's transformation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment safety and efficacy for patients with chronic lymphocytic leukemia.

How similar studies have performed: Other studies have shown promise in using venetoclax in combination therapies for CLL, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months.
* Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
* Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
* Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.

Exclusion Criteria:

\- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.

Where this trial is running

Tucson, Arizona and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaCLLVenetoclaxABT-199ObinutuzumabAcalabrutinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.