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Kinase Inhibitor

Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia (Captivate Trial)

Phase 2

Waitlist Available

Research Sponsored by Pharmacyclics LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.

Adequate hematologic function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose of ibrutinib to the first confirmed pd or death (up to primary analysis data cutoff date of 15 december 2020). overall median follow-up time was 38.2 months at the time of the primary analysis (data cutoff date: 15 december 2020).

Awards & highlights

Captivate Trial Summary

This trial is testing a new combination cancer therapy and whether it can be stopped early if the patient reaches minimal residual disease.

Who is the study for?

This trial is for people who have never been treated for CLL/SLL and meet specific criteria, like having enough healthy blood cells, no allergies to certain drugs used to prevent tumor complications, and measurable disease by CT scan. They must also have functioning liver and kidneys.Check my eligibility

What is being tested?

The study is testing a combination of two drugs, Ibrutinib and Venetoclax, against a placebo in patients with untreated CLL/SLL. It's designed to see if treatment can be stopped early based on minimal disease presence or if there's a benefit from taking the drugs for a set period.See study design

What are the potential side effects?

Ibrutinib may cause bleeding problems, infections, fatigue, muscle pain while Venetoclax might lead to tumor lysis syndrome (a rapid breakdown of cancer cells), diarrhea or nausea. The severity of side effects varies among individuals.

Captivate Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CLL/SLL and need treatment based on specific criteria.

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My blood counts are within a healthy range.

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My liver and kidneys are working well.

Captivate Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose until 30 days following last dose of study drug (up to data cutoff date of 15 dec 2020). treatment duration for the mrd cohort was 28.7 months for ibrutinib and 15.4 for venetoclax.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose until 30 days following last dose of study drug (up to data cutoff date of 15 dec 2020). treatment duration for the mrd cohort was 28.7 months for ibrutinib and 15.4 for venetoclax.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until 30 days following last dose of study drug (up to data cutoff date of 15 dec 2020). treatment duration for the mrd cohort was 28.7 months for ibrutinib and 15.4 for venetoclax. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FD Cohort: Complete Response Rate (CRR; Complete Response/Complete Response With Incomplete Blood Count Recovery [CR/CRi]) Rate

MRD Cohort: 1-Year Disease-Free Survival (DFS) Rate in Confirmed uMRD Randomized Participants

Secondary outcome measures

FD Cohort: DOR

FD Cohort: Kaplan-Meier Estimate of OS Rate at 24 Months Landmark Time

FD Cohort: Kaplan-Meier Estimate of PFS Rate at 24 Months Landmark Time

+21 more

Captivate Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: MRD Cohort/uMRD Not Confirmed: Randomized to Ibrutinib (Open-Label)Experimental Treatment2 Interventions

Participants receive 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre randomization phase). Participants with uMRD not confirmed are randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. In case of confirmed PD after restaging per iwCLL criteria, participants can continue ibrutinib and reintroduce venetoclax treatment. If venetoclax is to be reintroduced, venetoclax treatment is to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity.

Group II: MRD Cohort/uMRD Not Confirmed: Randomized Ibrutinib + Venetoclax (Open-Label)Experimental Treatment2 Interventions

Group III: MRD Cohort/Confirmed Undetectable MRD (uMRD): Randomized to Ibrutinib (Blinded)Experimental Treatment2 Interventions

Participants receive 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD are randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, disease progression (PD), or unacceptable toxicity. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, participants can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax is to be reintroduced, venetoclax treatment is to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity.

Group IV: Fixed Duration (FD) Cohort: Open Label Ibrutinib + VenetoclaxExperimental Treatment2 Interventions

Participants receive 420 mg of single-agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity.

Group V: MRD Cohort/Confirmed uMRD: Randomized Placebo (Blinded)Placebo Group3 Interventions

Participants receive 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD are randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants can first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax is to be reintroduced, venetoclax treatment is to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ibrutinib

2012

Completed Phase 3

~1070

venetoclax

2021

Completed Phase 2

~420

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pharmacyclics LLC.Lead Sponsor

113 Previous Clinical Trials

13,497 Total Patients Enrolled

Janssen Research & Development, LLCIndustry Sponsor

974 Previous Clinical Trials

6,383,947 Total Patients Enrolled

Joi Ninomoto, PharmDStudy DirectorPharmacyclics LLC.

Media Library

Ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02910583 — Phase 2

Chronic Lymphocytic Leukemia Research Study Groups: MRD Cohort/uMRD Not Confirmed: Randomized to Ibrutinib (Open-Label), Fixed Duration (FD) Cohort: Open Label Ibrutinib + Venetoclax, MRD Cohort/Confirmed Undetectable MRD (uMRD): Randomized to Ibrutinib (Blinded), MRD Cohort/Confirmed uMRD: Randomized Placebo (Blinded), MRD Cohort/uMRD Not Confirmed: Randomized Ibrutinib + Venetoclax (Open-Label)

Chronic Lymphocytic Leukemia Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02910583 — Phase 2

Ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02910583 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of participants taking part in this research?

"Unfortunately, this study has ceased recruitment for the time being. It was initially published on September 28th 2016 and last revisedon January 27th 2022. Alternately, there are currently 2865 trials enrolling patients with leukemia and 343 recruiting participants to receive venetoclax therapy."

Answered by AI

To what conditions is venetoclax typically prescribed?

"Venetoclax is capable of mitigating the effects of waldenstrom macroglobulinemia, small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll)."

Answered by AI

What other investigations have been conducted regarding venetoclax's efficacy?

"Venetoclax was initially studied at the NIH Clinical Center in 2011 and since then, a total of 18462 studies have been completed. Currently, there are 343 active trials with many based out of Charlotte, North carolina."

Answered by AI

Are there any age restrictions on the participants of this trial?

"As laid out in the study's inclusion requirements, no patient younger than 18 or older than 70 years of age can be admitted."

Answered by AI

Are there any open enrollment slots for this research study?

"The most recent edit to this trial on clinicaltrials.gov indicates that it is not currently accepting participants. This medical study was first posted in September of 2016, and while there are no open positions at the moment, 3208 other trials are actively seeking enrolment.."

Answered by AI

Are there any qualifications required for participants of this trial?

"This clinical trial seeks to recruit 323 individuals suffering from leukemia between the age of 18 and 70. To be eligible, one must have a diagnosis that abides by 2008 IWCLL diagnostic criteria, visible nodal disease on CT scans, satisfactory hepatobiliary & renal function as well as appropriate hematologic parameters (ANC >750/µL; platelet count>30,000 /μL; hemoglobin >8.0 g/dL)."

Answered by AI

Has the regulatory body approved venetoclax for medical use?

"Venetoclax has been deemed safe based on Phase 2 clinical data, and thus received a score of 2. However, no evidence to date supports its efficacy."

Answered by AI

How many locations are participating in this research experiment?

"There are 28 different clinical trial sites for this medical research, located in cities such as Charlotte, Chattanooga and Seattle. Therefore, it is wise to join the closest site available to lower any travelling demands that would come with participating in this study."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

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

Wierda, William G., John N. Allan, Tanya Siddiqi, Thomas J. Kipps, Stephen Opat, Alessandra Tedeschi, Xavier C. Badoux, et al.. 2021. “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”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00807.

clinicaltrials.govStudy

Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)

2016. "Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02910583.

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