A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

  • End date
    May 30, 2029
  • participants needed
  • sponsor
Updated on 4 October 2022
lymphoid leukemia
chronic lymphocytic leukemia
measurable disease
chronic lymphocytic leukemia refractory
17p deletion


This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).

Condition Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Treatment venetoclax
Clinical Study IdentifierNCT02966756
Last Modified on4 October 2022


Yes No Not Sure

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
Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening
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
Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI) treatment
No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score
of less than or equal to 2

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
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
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
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
Clear my responses

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