Back to search results

Phase II Study of Pirtobrutinib and Rituximab for Mantle Cell Lymphoma

This study is testing a chemotherapy-free combination of two drugs, pirtobrutinib and rituximab, for people with newly diagnosed low and intermediate risk Mantle Cell Lymphoma (MCL). Researchers want to see if this combination can lead to long-lasting remission. Both drugs are given by mouth (PO). The main goal is to understand how safe the treatment is and if it causes side effects. They also want to see how many people respond to the treatment. You may be able to join if you are 18 or older, have a confirmed diagnosis of MCL, and your cancer cells are CD20 positive. The study plans to enroll 50 patients, but the current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a single-arm study, meaning everyone receives the same treatment, and plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured throughout the study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06263491

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~50 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:RituximabPirtobrutinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Mantle Cell Lymphoma

Explore related trials

Mantle Cell LymphomaMKI67 GeneMS4A1 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ranjit Nair, MBBS, MD, DM, PhD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Ranjit Nair, MD
[email protected]
713-745-8041
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Medium risk - Ki-67% (\<=50%), largest tumor size \<=5 cm, no features of high-risk disease (see below in exclusion) 4. Participants with preexisting well-controlled cardio-vascular comorbidities - participants on anticoagulants (excluding warfarin and vitamin K antagonists), antiplatelet, anti-hypertensive, prior ablation, anti-arrhythmia, prior arrhythmias, baseline EKG abnormalities and cardiology clearance are allowed. Ejection fraction \>=50% and cardiology evaluation may be needed. (Echo and EKG and cardiology consultation within 2 months prior to C1D1 are allowed). 5. Understand and voluntarily sign an IRB-approved informed consent form. 6. Participants may have at least 1 site of radiographically assessable disease (i.e., lymph node longest diameter \[LDi\] \>= 1.5 cm, not necessary for disease assessable by positron emission tomography \[PET\]/computerized tomography \[CT\], extra nodal site \>= 1.0 cm in LDi. But participants with isolated gastrointestinal, bone marrow or spleen only disease patients are allowed. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (See Appendix III). 8. Prothrombin time (or international normalized ratio) and partial thromboplastin time not to exceed 1.2 times the institutional upper limit of normal range (participants with an elevated prothrombin time and known lupus anticoagulant may be eligible for participation after consulting the study PI).

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0