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B-cell Lymphoma-2 (BCL-2) Inhibitor

Pirtobrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Philip Thompson, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absolute neutrophil count (ANC) >= 1000/ul in the absence of growth factor support
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Must not have
History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor (CAR)-T therapy within the past 60 days or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing: Active graft versus host disease (GVHD), Need for anti-cytokine therapy for toxicity from CAR-T therapy, Residual symptoms of neurotoxicity > grade 1 from CAR-T therapy, Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
Patients who experienced a major bleeding event on a prior BTK inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to completion of cycle 24 (each cycle is 28 days)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing if a combination of two drugs can help control CLL/SLL that has been previously treated.

Who is the study for?
Adults with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have completed at least 12 cycles of venetoclax and still have detectable minimal residual disease. Participants must be in generally good health, with adequate organ function and blood counts, not pregnant or breastfeeding, willing to use effective contraception, and without certain heart conditions or other serious medical issues.
What is being tested?
The trial is testing the effectiveness of combining a new drug called pirtobrutinib (LOXO-305) with an existing treatment, venetoclax, to see if this combination can better control CLL/SLL after previous treatments. The goal is to eliminate any remaining cancer cells that were not cleared by prior therapy.
What are the potential side effects?
Potential side effects may include diarrhea, fatigue, muscle and bone pain from pirtobrutinib; nausea, low white blood cell count leading to increased infection risk from venetoclax. There could also be risks associated with taking both medications together which are currently unknown.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My white blood cell count is healthy without needing medication.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My kidneys are functioning well enough (creatinine clearance >= 30 ml/min).
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I've been treated with venetoclax for 12 cycles and still have minimal cancer cells detected.
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I have been diagnosed with CLL 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 haven't had a stem cell transplant or CAR-T therapy in the last 60 days and don't have active GVHD, need for anti-cytokine therapy, symptoms of neurotoxicity > grade 1, or uncontrolled auto-immune cytopenia.
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I had a major bleeding event while on a BTK inhibitor.
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I have been treated with a BTK inhibitor like nemtabrutinib before.
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My CLL is affecting or might affect my brain or spinal cord.
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My condition has transformed into a more aggressive form of cancer.
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I need blood thinners like warfarin for my condition.
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I have not had major surgery in the last 4 weeks.
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I am not taking more than 20 mg of prednisone or any similar steroid daily for cancer treatment.
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I have a condition that affects how my body absorbs medication taken by mouth.
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I don't have any lasting side effects from previous treatments, except for hair loss.
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I have had a severe irregular heartbeat from previous BTK inhibitor treatment.
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I am not allergic to any part of LOXO-305 or venetoclax.
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I do not have active hepatitis B or C.
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I do not have serious heart problems.
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I am not taking any strong medications that affect liver enzymes or consuming grapefruit, Seville oranges, or star fruit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to completion of cycle 24 (each cycle is 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to completion of cycle 24 (each cycle is 28 days) 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 (U) minimal residual disease (MRD) in the peripheral blood

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05176314
9%
Petechiae
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
200 mg Pirtobrutinib QD (Days 7-12)
20 mg Rosuvastatin (Day 1)
200 mg Pirtobrutinib QD (Days 14-17)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: Pirtobrutinib+venetoclaxExperimental Treatment2 Interventions
Pirtobrutinib by mouth at the same time each day Venetoclax by mouth at the same time each day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Venetoclax
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,201 Total Patients Enrolled
Philip Thompson, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Alessandra Ferrajoli, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
403 Total Patients Enrolled

Media Library

Venetoclax (B-cell Lymphoma-2 (BCL-2) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05317936 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Pirtobrutinib+venetoclax
Chronic Lymphocytic Leukemia Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT05317936 — Phase 2
Venetoclax (B-cell Lymphoma-2 (BCL-2) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317936 — Phase 2
~26 spots leftby Oct 2027
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