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Mantle Cell LymphomaAugust 2023Summary reviewed May 2026

A BTK Inhibitor Pill Shrank Blood Cancer in 58% of Treatment-Resistant Patients

BRUIN tested pirtobrutinib, a different kind of BTK inhibitor pill, in mantle cell lymphoma patients whose cancer had already come back after the standard BTK drugs (ibrutinib, acalabrutinib, or zanubrutinib). Across 166 patients, more than half saw their tumors shrink, and responses lasted nearly two years on average.

What the trial was testing

The BRUIN enrolled 166 patients with mantle cell lymphoma. The study was sponsored by Loxo Oncology and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was an early-stage trial — researchers are still confirming safety and getting an early look at how well the treatment works. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

58% of patients responded after their previous BTK inhibitor stopped working.

Journal of Clinical Oncology · 2023 · NCT03740529

These findings — that saw their mantle cell lymphoma respond to pirtobrutinib after other BTK inhibitors stopped working — were published in the Journal of Clinical Oncology and represent the headline result of the study.

Researchers tracked outcomes across 166 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with mantle cell lymphoma, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Pirtobrutinib (Jaypirca) received FDA accelerated approval in January 2023 for relapsed or refractory mantle cell lymphoma after at least two prior therapies, including a BTK inhibitor. It's a daily pill taken at home — a meaningful option when standard BTK drugs stop working, and when CAR-T therapy isn't right for you. Ask your oncologist whether you qualify.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.

Open mantle cell lymphoma trials

RecruitingTesting effectiveness

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CD19, a protein on the surface of the cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19 positive cancer cells. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CD19 CAR T cells together with acalabrutinib may kill more cancer cells.

Duarte, California, United States
RecruitingTesting effectiveness

A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.

Shanghai, Shanghai Municipality, China