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Kinase Inhibitor

Pirtobrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Kerry A Rogers, MD

Research Sponsored by Kerry Rogers

Eligibility Criteria Checklist

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

Must have

No known inherited qualitative platelet defect (e.g. delta granule storage pool deficiency)

Diagnosis of CLL or SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines

Must not have

Need for treatment with warfarin or other vitamin K antagonist during study treatment

Inability to take pills or oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after last dose of study drugs

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a combination of two drugs, pirtobrutinib and venetoclax, to see how well they work in treating patients with chronic lymphocytic leukemia (CLL

Who is the study for?

This trial is for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who haven't responded to previous treatments with covalent BTK inhibitors. Participants should meet specific health criteria and not have conditions that would exclude them from the study.

What is being tested?

The trial is testing a combination of two drugs, pirtobrutinib (LOXO-305) and venetoclax, on patients with CLL or SLL resistant to other treatments. It includes procedures like bone marrow aspiration/biopsy, CT scans, and biospecimen collection to monitor effects.

What are the potential side effects?

Possible side effects include those common to cancer treatments such as fatigue, nausea, risk of infection due to low blood cell counts, bleeding complications, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any inherited blood platelet disorders.

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I have been diagnosed with CLL or SLL following the 2018 iwCLL guidelines.

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My blood or bone marrow tests show signs of chronic lymphocytic leukemia.

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My CLL has worsened according to iwCLL 2018 criteria.

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My kidney function, measured by creatinine clearance, is adequate.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My blood cancer is getting worse despite treatment.

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My liver tests are within the required limits.

Exclusion Criteria

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

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I need warfarin or similar medication during the study.

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I cannot take pills or oral medications.

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I have a history of abnormal bleeding.

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I haven't had major radiation therapy in the last 14 days or small area radiation in the last 7 days.

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I had severe bleeding or a serious irregular heartbeat from previous BTK inhibitor treatment.

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I do not have a condition that affects how my stomach and intestines absorb medicine.

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I have serious heart issues, including recent heart attacks or severe heart failure.

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I cannot handle drinking or receiving 2 liters of fluids through IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after last dose of study drugs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after last dose of study drugs

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after last dose of study drugs for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of undetectable minimal residual disease (uMRD)

Secondary study objectives

Best overall response rate (ORR)

Incidence of adverse events (AEs)

OS for patients who achieve uMRD and those who do not achieve uMRD with pirtobrutinib and venetoclax

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pirtobrutinib, venetoclax)Experimental Treatment6 Interventions

Patients receive pirtobrutinib PO QD on days 1-28 of each cycle and receive venetoclax PO QD on days 1-28 of cycles 2-20. Cycles repeat every 28 days for up to 20 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression within 12 months of stopping combination treatment may receive pirtobrutinib PO QD in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy and CT throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pirtobrutinib

2020

Completed Phase 1

~240

Biospecimen Collection

2004

Completed Phase 3

~2030