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Kinase Inhibitor

Ibrutinib + Venetoclax for 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

Must not have

Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone > 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease

Known or suspected Richter's transformation or central nervous system (CNS) involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have worsening anemia or low platelets due to autoimmunity, nor need high-dose steroids.

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My condition has not progressed to Richter's transformation or spread to my brain.

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I have a known bleeding disorder like von Willebrand's or hemophilia.

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I have not had a stroke or brain bleed in the last 6 months.

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I do not have serious heart problems like uncontrolled irregular heartbeat or severe heart failure.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Overall Response Rate (ORR)

Secondary study objectives

Adherence Rates

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

Complete Response (CR) Rate

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Venetoclax

2019

Completed Phase 3

~2240

Ibrutinib

2014

Completed Phase 4

~2060