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Evaluating venetoclax for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 2 Interventional AbbVie · NCT02966756

This study is testing if a medication called venetoclax can help people with relapsed or hard-to-treat chronic lymphocytic leukemia or small lymphocytic lymphoma feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment110 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations31 sites (Concord, New South Wales and 30 other locations)
Trial IDNCT02966756 on ClinicalTrials.gov

What this trial studies

This Phase 2, open-label, multicenter study assesses the efficacy of venetoclax in patients diagnosed with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants are divided into two cohorts: one with 17p deletion and another who have failed previous therapies including B-receptor signaling pathway inhibitors and chemoimmunotherapy. The study aims to determine the effectiveness of venetoclax in these specific patient populations. The treatment will be administered according to established guidelines for CLL/SLL.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory CLL/SLL who have received at least one prior line of therapy and meet specific eligibility criteria.

Not a fit: Patients who have not been diagnosed with relapsed or refractory CLL/SLL or those who have not received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat forms of CLL/SLL.

How similar studies have performed: Other studies have shown promising results with venetoclax in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that meets 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines and the following:

  * Participant must have an indication for treatment according to the 2008 Modified iwCLL NCI-WG Guidelines.
  * SLL participant must have measurable disease (B-lymphocytosis greater than 5 × 10\^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) \> 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL).
  * SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate.
  * Participant must have relapsed or refractory CLL/SLL after receiving at least one prior line of therapy.
* Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory.
* Participants (in Cohort 2) must meet both of the following:

  * Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI) treatment;
  * And either of the following: (a) relapsed/refractory disease to chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having known 17p deletion or TP53 mutation, or Cumulative Illness Rating Scale (CIRS) \>6 or calculated creatinine clearance \<70 mL/min, or participants in whom the investigator evaluated that the use of CIT was inappropriate.
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
* Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening.
* No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Exclusion Criteria:

* Participant has undergone an allogeneic stem cell transplant.
* Participant has developed Richter's transformation confirmed by biopsy.
* Participant has prolymphocytic leukemia.
* Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP).
* Participant has previously received venetoclax or other BCL-2 inhibitors.
* Participant is known to be positive for Human Immunodeficiency Virus (HIV).
* Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
* Participant has received any of the following within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of venetoclax, or has not recovered to less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:

  * Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or targeted small molecule agents.
  * Investigational therapy, including targeted small molecule agents.
* Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.

Where this trial is running

Concord, New South Wales and 30 other locations

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 LeukemiaSmall Lymphocytic LymphomaRelapsed chronic lymphocytic leukemiaRefractory chronic lymphocytic leukemia17p deletionVenetoclaxLeukemiaLymphoproliferative Disorders
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.