NCT02966756 A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
| NCT ID | NCT02966756 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AbbVie |
| Condition | Chronic Lymphocytic Leukemia (CLL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2017-10-12 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2017-10-12 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT02966756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukemia (CLL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02966756 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02966756 currently recruiting?
Yes, NCT02966756 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT02966756 trial being conducted?
This trial is being conducted at Concord, Australia, Kogarah, Australia, Clayton, Australia, Hefei, China and 11 additional locations.
Who is sponsoring the NCT02966756 clinical trial?
NCT02966756 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 110 participants.
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