Mantle cell lymphoma (MCL) is an aggressive B-cell blood cancer that is considered incurable with standard therapy but has been transformed by BTK inhibitors. It is most common in older men and often presents at an advanced stage.
What's actually going on in research
Ibrutinib and acalabrutinib have dramatically improved outcomes for relapsed MCL, and BTK inhibitors are now being incorporated into front-line treatment. Pirtobrutinib, a non-covalent BTK inhibitor, offers options for patients who have progressed on covalent BTK inhibitors. CAR-T cell therapy for relapsed MCL is showing durable responses in patients who have exhausted other options.
BTK inhibitors upfront
Adding ibrutinib or acalabrutinib to front-line chemoimmunotherapy is being tested in large trials to see if incorporating BTK inhibition from the start improves long-term outcomes.
Non-covalent BTK inhibitors
Pirtobrutinib achieves responses in MCL that has progressed on covalent BTK inhibitors like ibrutinib, addressing a major unmet need in relapsed and refractory disease.
CAR-T for MCL
Brexucabtagene autoleucel (a CAR-T therapy) produces durable remissions in relapsed MCL, and trials are testing it in earlier lines and comparing it with transplant approaches.
What to know before you search
Eligibility depends on MCL stage, Ki-67 proliferation index, TP53 mutation status, prior BTK inhibitor exposure, and age and fitness for intensive therapy.
What types of trials are currently open
- Front-line treatment trials — Testing BTK inhibitor-containing front-line regimens versus standard chemoimmunotherapy.
- Relapsed MCL trials — Evaluating non-covalent BTK inhibitors, venetoclax combinations, and bispecific antibodies.
- CAR-T trials — Testing CAR-T cell therapy positioning in the treatment sequence for MCL.
- Transplant trials — Comparing autologous stem cell transplant consolidation to continuous BTK inhibitor therapy.
- MRD-guided trials — Testing minimal residual disease-directed treatment intensification or de-escalation.
Recently added Mantle Cell Lymphoma trials
Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma
A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor. Patients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi. Patients will be enrolled according to a Simon two-stage design, with early stop criteria for lack of efficacy. Glofitamab will be administered intravenously and lenalidomide will be self-administered orally. Obinutuzumab pretreatment will be administered intravenously as 2 doses of 1000 mg prior to glofitamab initiation. The primary endpoint is BOR at the end of induction, evaluated by PET/CT according to Lugano criteria during study enrolment. The primary objective is to evaluate the best objective response rate (BOR) at the end of induction of the combination of glofitamab and lenalidomide.
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).
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