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

Launched by ABBVIE · Nov 15, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a medication called venetoclax in patients who have relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This means the cancer has returned or hasn’t responded to previous treatments. The trial aims to see how effective venetoclax is for participants with specific genetic changes (like 17p deletion) or those who have not responded to certain therapies. It is currently recruiting participants aged 65 and older, regardless of gender, who have had at least one prior treatment for their condition and meet other health criteria.

Participants in this study can expect to receive venetoclax, and they will be closely monitored for its effects and any side effects. To join the trial, individuals must meet specific health guidelines and should not have certain conditions, like recent severe infections or prior treatments that could interfere with the study. This trial is important as it could provide new options for people with difficult-to-treat forms of CLL or SLL. If you or someone you know is interested in participating, it's a good idea to discuss it with a healthcare provider for more information.

Gender

ALL

Eligibility 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.