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Study of Venetoclax with Obinutuzumab or Acalabrutinib for Untreated CLL

This study is for adults with previously untreated chronic lymphocytic leukemia (CLL), a type of blood cancer. It aims to understand the safety of venetoclax when given with either obinutuzumab or acalabrutinib. Researchers want to see how often a side effect called Tumor Lysis Syndrome (TLS) occurs, which is a rapid breakdown of cancer cells that can cause problems. You would receive venetoclax by mouth, combined with either obinutuzumab given through a vein (IV) or acalabrutinib taken by mouth. The study will also look at any other side effects and how your disease activity changes. About 170 participants are planned for this study.

Study design
This interventional study plans to enroll 170 participants into one of four treatment groups. Participants will receive oral venetoclax in combination with either intravenous obinutuzumab or oral acalabrutinib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints, including the risk of Tumor Lysis Syndrome and hyperkalemia, will be measured for up to 28 months.

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NCT06428019

A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Recruiting
PHASE3Ages 18+InterventionalTreatment
AbbVie
~170 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:VenetoclaxAcalabrutinibObinutuzumab

At a glance

Recruiting sites
69 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax
Measured over Up to 28 Months
+1 more outcome measured

Conditions

Chronic Lymphocytic Leukemia

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

70 sites across 52 states
Florida4
Attica3
Beograd3
Spain3
Taiwan3
Arizona2
California2
Maryland2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-VenetoclaxUp to 28 Months

    TLS is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with chronic lymphocytic leukemia (CLL) achieving a medium tumor burden with creatinine clearance (CrCl) of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.

  • Part 1: Percentage of Participants with Hyperkalemia-VenetoclaxUp to 28 Months

    Hyperkalemia (potassium \>6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per IRC assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.