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RecruitingLast updated: 31 January 2024

M14-728: This phase II trial is evaluating an oral chemotherapy drug (Venetoclax) in participants with Chronic Lymphocytic Leukaemia (CLL)A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia in the Presence of 17p Deletion

Clinical summary


Participants in this trial will receive Venetoclax via oral administration, starting with a 20mg dose once daily (QD). Dose escalation will occur weekly in the following progression: 50mg QD, 100mg QD, 200mg QD, 400mg QD, as tolerated.


This trial is treating patients with Chronic Lymphocytic Leukaemia (CLL)


Blood Cancers Haematological





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Trial sponsor


Scientific Title

A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia in the Presence of 17p Deletion



  • 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.


  • 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.
  • 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.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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