Pirtobrutinib for Chronic Lymphocytic Leukemia

Not yet recruiting at 1 trial location

Overseen By Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Eli Lilly and Company

Disqualifiers: Not in prior study

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

Compensation: Varies

Number of Visits: 4

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on assessing the long-term safety of a drug called pirtobrutinib for individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial will compare pirtobrutinib with idelalisib, a kinase inhibitor, to evaluate their effectiveness. It is open to participants from a related study who wish to continue their treatment. Those who have been managing CLL or SLL and participated in the previous study may find this trial suitable. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for these treatments?

A previous study found pirtobrutinib to be safe for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Most patients experienced only mild side effects, as it effectively targets certain resistant forms of the disease without causing severe harm.

Idelalisib, however, has demonstrated significant benefits but also presents some risks. About 40% of patients experienced serious side effects, including lung problems. These side effects can be managed but require careful monitoring.

Both treatments show promise, but participants must understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Pirtobrutinib is unique because it targets chronic lymphocytic leukemia (CLL) by inhibiting Bruton's tyrosine kinase (BTK), but it does so in a reversible manner. Unlike current treatments like ibrutinib and acalabrutinib, which bind irreversibly to BTK, pirtobrutinib can potentially reduce side effects and overcome resistance seen with these other drugs. Researchers are particularly excited about its potential to offer a more flexible and effective treatment option for patients who have developed resistance or intolerance to existing BTK inhibitors. Additionally, its oral administration is convenient, making it an appealing option for ongoing management of CLL.

What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?

This trial will compare Pirtobrutinib and Idelalisib for treating chronic lymphocytic leukemia (CLL). Research has shown that Pirtobrutinib is effective for CLL and small lymphocytic lymphoma (SLL), with 62% of patients responding and an average of 20 months without disease progression. It also improved survival rates compared to standard treatments. Idelalisib, another treatment option in this trial, has helped patients with relapsed CLL live longer and improve their condition, extending the time without disease worsening compared to other treatments. Overall, both treatments have shown promise in treating CLL and SLL. ^{4 5 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and have been treated before. Participants must have completed the J2N-MC-JZNN/LOXO-BTK-20020 study to join this one for continued treatment or follow-up.

Inclusion Criteria

Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020

Exclusion Criteria

This is not applicable to this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pirtobrutinib or idelalisib orally every 4 weeks

5 years

Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 93 months

What Are the Treatments Tested in This Trial?

Interventions

• Pirtobrutinib

Trial Overview The study tests the long-term safety of a drug called pirtobrutinib in treating CLL/SLL. Patients will receive treatment every four weeks over approximately five years, with some possibly receiving idelalisib as a comparison.

How Is the Trial Designed?

Group I: Pirtobrutinib (Arm A) Experimental Treatment 1 Intervention

Participants receive pirtobrutinib orally

Group II: Idelalisib (Arm B) Experimental Treatment 1 Intervention

Participants receive idelalisib orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead 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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10567876/

real world data from the registry of the German CLL Study ... Median overall survival was 46.6 months. In conclusion, treatment with idelalisib appears to have a valuable impact in patients being refractory ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.18.01460

Final Results of a Randomized, Phase III Study ... IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01569295

NCT01569295 | Study Evaluating the Efficacy and Safety of ... Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 ...

4. ashpublications.org ashpublications.org/ashclinicalnews/news/4997/Outcomes-With-Idelalisib-Differ-in-the-Clinical?searchresult=1

Outcomes With Idelalisib Differ in the Clinical Trial Versus ... The median treatment duration was shorter for real-world patients with CLL compared with clinical trial participants (173 days vs. 473 days; p< ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1315226

Idelalisib and Rituximab in Relapsed Chronic Lymphocytic ... Results. The median progression-free survival was 5.5 months in the placebo group and was not reached in the idelalisib group (hazard ratio for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4732460/

Management of adverse events associated with idelalisib ... Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0006497119837898

Safety and Efficacy of Idelalisib Treatment of Chronic ... Altogether, there were 11 deaths, all due to disease progression (CLL 7, lymphoma 4). Median OS from start of idelalisib for all 24 patients was 362 days, with ...

8. zydelig.com zydelig.com/hcp

ZYDELIG® (idelalisib) for Relapsed CLL | HCP Site Fatal and/or serious pneumonitis occurred in 4% of ZYDELIG-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or ...