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RecruitingLast updated: 4 June 2025

A study recruiting people with chronic lymphocytic leukaemia (CLL) to assess the safety of venetoclax targeted therapy in combination with other targeted therapiesA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

Venetoclax, an oral targeted therapy, in combination with other targetd therapies (obinutuzumab or acalabrutinib) is being investigated in this study for the treatment of previously untreated chronic lymphocytic leukaemia (CLL). You may also be eligible for this study if you have previously untreated small lymphocytic lymphoma (SLL).

Study doctors will put eligible participants in one of four groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib in different dosing schemes as part of treatment.

  • Participants in Arm A will receive oral venetoclax + IV infused obinutuzumab, with a 5 week venetoclax ramp-up.
  • Participants in Arm B will receive oral venetoclax + oral acalabrutinib, with a 5 week venetoclax ramp-up.
  • Participants in Arm C and Arm D will receive oral venetoclax + oral acalabrutinib, with differing venetoclax ramp-up periods.

The total study duration is approximately 28 months.

There may be a 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 treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

 

Conditions

This trial is treating people with previously untreated chronic lymphocytic leukaemia, or small lymphocytic lymphoma

Eligibility

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.

Exclusion

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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AbbVie

Scientific 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

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