Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Summary
This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.
Timeline
- Start
- 2016-09-28
- Primary completion
- 2020-11-12
- Completion
- 2024-03-27
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) vs MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded); p = 0.1475 reads as mixed primary results NCT02910583 ↗
registry Difference in Rates 4.7 (95% CI -1.6 to 10.9) reads as mixed primary results NCT02910583 ↗
registry analysis (superiority test); FD Cohort, Non-Del 17p Population; p < 0.0001; asymptotic test for binomial proportion reads as mixed primary results NCT02910583 ↗
registry One-sided P-value from asymptotic test for the binomial proportion (CRR \<= 37% vs CRR \> 37%). reads as mixed primary results NCT02910583 ↗
release “Results from the randomized phase of the MRD Guided Cohort of the CAPTIVATE study confirm that treatment-free remissions are possible with IMBRUVICA-based fixed duration therapy” reads as met primary endpoint jnj.com ↗
Publications
- Moreno C, Solman IG, Tam CS, Grigg A, Scarfo L, Kipps TJ, Srinivasan S, Mali RS, Zhou C, Dean JP, Szafer-Glusman E, Choi M. Immune restoration with ibrutinib plus venetoclax in first-line chronic lymphocytic leukemia: the phase 2 CAPTIVATE study. Blood Adv. 2023 Sep 26;7(18):5294-5303. doi: 10.1182/bloodadvances.2023010236.
- Wierda WG, Allan JN, Siddiqi T, Kipps TJ, Opat S, Tedeschi A, Badoux XC, Kuss BJ, Jackson S, Moreno C, Jacobs R, Pagel JM, Flinn I, Pak Y, Zhou C, Szafer-Glusman E, Ninomoto J, Dean JP, James DF, Ghia P, Tam CS. Ibrutinib Plus Venetoclax for First-Line Treatment of Chronic Lymphocytic Leukemia: Primary Analysis Results From the Minimal Residual Disease Cohort of the Randomized Phase II CAPTIVATE Study. J Clin Oncol. 2021 Dec 1;39(34):3853-3865. doi: 10.1200/JCO.21.00807. Epub 2021 Oct 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |