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Taking people in SerbiaPhase 3

Tests venetoclax with obinutuzumab or acalabrutinib in untreated chronic lymphocytic leukemia

Tests venetoclax with obinutuzumab or acalabrutinib in adults with untreated chronic lymphocytic leukemia.

Key facts

Who runs it
AbbVie
Where
Belgrade, Kamenitz, Kragujevac, Niš, and Novi Sad, SerbiaSee the 7 sitesAlso in 8 other countries, 63 sites
Registry title
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)
Status
Recruiting
Phase
Phase 3
People taking part
170 people, planned
Started
5 Aug 2024
Expected to end
Mar 2028
Type of study
Interventional, 4 groups
Treatments tested
  • Venetoclax
  • Acalabrutinib
  • Obinutuzumab
Record updated
9 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have never been treated and now need treatment.

Age
18 years or older
Sex
All sexes can join.
Disease stage
CLL or SLL that needs treatment according to the 2018 iwCLL criteria. Life expectancy of more than 6 months.
Earlier treatment
No earlier treatment for CLL or SLL.

Main reasons for not taking part

  • Active or uncontrolled infection
  • Richter's transformation
  • Active immune thrombocytopenia

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia

Where in Serbia

Also in 8 other countries, 63 sites

  • Clinical Hospital Center - Bežanijska Kosa /ID# 266567Belgrade, SerbiaTaking people
  • Clinical Hospital Center Zvezdara /ID# 266560Belgrade, SerbiaTaking people
  • University Clinical Center Serbia /ID# 266579Belgrade, SerbiaTaking people
  • Institute for Oncology of Vojvodina /ID# 266556Kamenitz, SerbiaTaking people
  • University Clinical Center Kragujevac /ID# 266568Kragujevac, SerbiaTaking people
  • University Clinical Center Nis /ID# 266580Niš, SerbiaTaking people
  • University Clinical Center Vojvodina /ID# 266674Novi Sad, SerbiaTaking people

About the trial

What the trial wants to find out

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.

Read full original descriptionShow less

Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.

Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

The 4 groups in the trial

  • Arm A: Venetoclax + ObinutuzumabTreatment being tested

    Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.

    Treatment: Venetoclax and Obinutuzumab

  • Arm B: Venetoclax + AcalabrutinibTreatment being tested

    Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.

    Treatment: Venetoclax and Acalabrutinib

  • Arm C: Venetoclax + AcalabrutinibTreatment being tested

    Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.

    Treatment: Venetoclax and Acalabrutinib

  • Arm D: Venetoclax + AcalabrutinibTreatment being tested

    Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.

    Treatment: Venetoclax and Acalabrutinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests venetoclax with obinutuzumab or acalabrutinib in untreated chronic lymphocytic leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 April 2026