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Kinase Inhibitor

Cohort 2b: Continuous Ibrutinib Monotherapy for Chronic B-Cell Leukemia (TAILOR Trial)

Phase 2

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (>=) 1.5 centimeters (cm) in longest diameter

Diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

TAILOR Trial Summary

This trial aims to compare the effectiveness and safety of using a combination of ibrutinib and venetoclax versus using ibrutinib alone. They will also look at how adjusting

Who is the study for?

This trial is for adults with untreated chronic lymphocytic leukemia who are not pregnant or breastfeeding, agree to use contraception, and have a certain level of physical function (ECOG status). They must have measurable disease by CT scan. People planning pregnancy soon after the study or those with other health conditions that could interfere are excluded.Check my eligibility

What is being tested?

The study tests two treatment methods: Ibrutinib alone, and in combination with Venetoclax. It aims to see how effective they are and if adjusting Ibrutinib doses can reduce side effects while maintaining benefits.See study design

What are the potential side effects?

Ibrutinib may cause diarrhea, bleeding problems, high blood pressure, infections, fatigue. Venetoclax might lead to low white blood cell count increasing infection risk, nausea, diarrhea again, anemia causing tiredness.

TAILOR Trial Eligibility Criteria

Inclusion Criteria

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

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I have a lymph node that is at least 1.5 cm big, confirmed by a CT scan.

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I have been diagnosed with CLL/SLL according to the 2018 iwCLL criteria.

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I have a lymph node that is at least 1.5 cm big, confirmed by a CT scan.

Select...

I have been diagnosed with CLL/SLL according to the 2018 iwCLL criteria.

TAILOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Best Overall Response Rate (ORR)

Secondary outcome measures

Adherence Rates

Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate

Complete Response (CR) Rate

+12 more

TAILOR Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 2b: Continuous Ibrutinib MonotherapyExperimental Treatment1 Intervention

Participants will receive ibrutinib 420 mg QD for 1 cycle (1 cycle = 28 days) followed by Ibrutinib 280 mg QD (or last tolerated dose) and continue until disease progression or unacceptable toxicity.

Group II: Cohort 2a: Continuous Ibrutinib MonotherapyExperimental Treatment1 Intervention

Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.

Group III: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+VenetoclaxExperimental Treatment2 Interventions

Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15.

Group IV: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+VenetoclaxExperimental Treatment2 Interventions

Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~1890

Venetoclax

2019

Completed Phase 3

~1990

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,372 Total Patients Enrolled

Pharmacyclics LLC.Industry Sponsor

113 Previous Clinical Trials

13,495 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,959,958 Total Patients Enrolled

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 patient population enrolled in this clinical trial?

"For this research study, a total of 320 eligible participants are required for enrollment. Patients meeting the defined inclusion criteria have the opportunity to join from diverse locations like Oncology Hematology Care in Cincinnati, Ohio and Willamette Valley Cancer Institute and Research Center in Eugene, Oregon."

Answered by AI

Are patients currently able to enroll in this ongoing medical study?

"Affirmed. Details on clinicaltrials.gov affirm that this medical investigation is actively seeking participants. The trial was initially published on February 27th, 2024, with the most recent update made on January 30th, 2024. Enrollment aims to reach a total of 320 patients spread across six designated sites."

Answered by AI

Are there multiple locations in North America conducting this clinical trial?

"At present, patient recruitment is ongoing at 6 distinct sites. These include locations in Cincinnati, Eugene, Cerritos, and another half-dozen cities. Opting for the nearest site to your location can help reduce travel burdens upon enrollment."

Answered by AI

Has the FDA granted approval for Cohort 2b, which involves continuous use of Ibrutinib as a standalone treatment?

"The safety rating for Cohort 2b, focusing on continuous Ibrutinib monotherapy, is assessed as a 2 by our team at Power. This score reflects the ongoing Phase 2 trial status where some safety data exists without evidence of efficacy yet demonstrated."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

2024. "A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05963074.

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