RecruitingPhase 2NCT05734495

Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia

A Phase II Study Evaluating Venetoclax and Pirtobrutinib in Previously Treated Waldenström Macroglobulinemia


Sponsor

Dana-Farber Cancer Institute

Enrollment

42 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to examine the safety and effectiveness of pirtobrutinib combined with venetoclax as a possible treatment for participants with Waldenström Macroglobulinemia (WM). The names of the study drugs involved in this study are: * Pirtobrutinib (a Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor) * Venetoclax (a BCL2 inhibitor)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests the combination of two targeted drugs — pirtobrutinib (a BTK inhibitor) and venetoclax (a BCL-2 inhibitor) — in people with Waldenström macroglobulinaemia (WM), a rare slow-growing blood cancer. Both drugs target key survival pathways in cancer cells. The study is for patients who have already received at least one prior treatment and whose disease is active and causing symptoms. **You may be eligible if...** - You are 18 or older and have been diagnosed with Waldenström macroglobulinaemia - You have had at least one previous treatment - Your disease is causing symptoms (such as fatigue, anaemia, low platelets, or neuropathy) - Your IgM protein level is measurably elevated (above twice the upper limit of normal) - Your organ function (kidneys, liver, blood counts) meets minimum criteria **You may NOT be eligible if...** - You have previously taken a non-covalent BTK inhibitor (a newer class of BTK-blocking drugs) - You had a major bleeding event or severe heart rhythm problem while on a BTK inhibitor - You have active hepatitis B or C, or HIV with active cytomegalovirus - You have cancer spread to the brain or spinal fluid - You are pregnant or breastfeeding - You are taking warfarin or strong CYP3A4-affecting medications that cannot be stopped Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPirtobrutinib

Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor, tablet taken orally.

DRUGVenetoclax

Small-molecule B-cell lymphoma-2 (Bcl-2) family inhibitor, tablet taken orally.


Locations(2)

Beth Israel Deaconness Medical

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05734495


Related Trials