Phase 3
N=258
A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02756611 ↗Enrolled (actual)
258
Serious AEs
52.7%
Results posted
May 2020
Primary outcome: Primary: Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis — 35.1 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Venetoclax (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis |
35.1 | <0.001 sig |
| SECONDARY Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary Analysis |
25.4 | — |
| SECONDARY Overall Response Rate (ORR) - Primary Analysis |
79.8 | — |
| SECONDARY Duration of Overall Response (DOR) - Primary Analysis |
25.2 | — |
| SECONDARY Time to Progression (TTP) - Primary Analysis |
30.5 | — |
| SECONDARY Progression-Free Survival (PFS) - Primary Analysis |
30.5 | — |
| SECONDARY Overall Survival (OS) - Primary Analysis |
NA | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) |
1.2; 0.9; 0.2; -0.4; 2.1; 1.7 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) |
4.9; 3.3 | — |
| SECONDARY Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score |
8.5; 7.1 | — |
Summary
The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.
Eligibility Criteria
Inclusion Criteria
- Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
- Participant has relapsed/refractory disease (received at least 1 prior therapy)
- Participant has diagnosis of CLL that meets published 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines and:
- has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria
- has clinically measurable disease (lymphocytosis greater than 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
- In addition, participants:
- with or without 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood are eligible
- may have been previously treated with a prior B-cell receptor inhibitor
- Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory at Screening
Exclusion Criteria
- Participant has developed Richter's transformation or Prolymphocytic leukemia
- Participant has previously received venetoclax
- History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:
- adequately treated in situ carcinoma of the cervix uteri
- adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
- previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
- Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids
- Participant has undergone an allogeneic stem cell transplant
- Treatment with any of the following within five half-lives or 14 days (if half-life unknown) as applicable prior to the first dose of venetoclax, or clinically significant adverse effect(s)/toxicity(s) of the previous therapy have not resolved to < National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade 2:
- Any anti-cancer therapy including chemotherapy, or radiotherapy;
- Investigational therapy, including targeted small molecule agents
- Participant is human immunodeficiency virus (HIV) positive
- Participant has known allergy to both xanthine oxidase inhibitors and rasburicase
Data sourced from ClinicalTrials.gov (NCT02756611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.