Pirtobrutinib + Venetoclax + Obinutuzumab for Chronic Lymphocytic Leukemia

Overseen By Alessandra Ferrajoli, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 13 cycles (approximately 13 months)

40 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

Research Team

Alessandra Ferrajoli, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with recurrent CLL/SLL who have previously undergone treatment. Specific eligibility criteria are not provided, but typically include factors like age, health status, and disease characteristics.

Inclusion Criteria

I have been diagnosed with CLL/SLL according to 2018 standards.

I have CLL needing treatment as per 2018 guidelines.

My side effects from previous treatments are mild, except for hair loss and some nerve pain.

Exclusion Criteria

I had a major bleeding event on a previous BTK inhibitor treatment.

I need blood thinners like warfarin for my condition.

I don't have major kidney, brain, mental health, hormone, metabolism, or immune issues that could affect my study participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pirtobrutinib, Venetoclax, and Obinutuzumab in cycles, with primary objectives measured at the end of Cycle 13

13 cycles (approximately 13 months)

Follow-up

Participants are monitored for safety, progression-free survival, and overall survival

12 months

Treatment Details

Interventions

• Obinutuzumab
• Pirtobrutinib
• Venetoclax

Trial Overview The study tests a combination of three drugs: Pirtobrutinib, Venetoclax, and Obinutuzumab (PVO), to see if they can effectively control relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).

Participant Groups

Group I: V-Naive Experimental Treatment 3 Interventions

Venetoclax Naive: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W

Group II: V-Exposed Experimental Treatment 3 Interventions

Venetoclax Exposed: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University