Nemtabrutinib with Rituximab for Mantle Cell Lymphoma
This study is testing a combination of two drugs, nemtabrutinib and rituximab, for people with mantle cell lymphoma. Nemtabrutinib is a kinase inhibitor, meaning it blocks a protein called BTK that is often found at high levels in mantle cell lymphoma cells, which may help stop cancer growth. Rituximab is a monoclonal antibody that targets a protein called CD20 on cancer cells, helping your immune system fight them. Researchers hope that giving these two drugs together will be more effective. This study is for adults aged 18 or older with a confirmed diagnosis of mantle cell lymphoma and a good general health status (ECOG score of 2 or less). The main goal is to see how many patients have a complete response to the treatment. This study plans to enroll 27 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 27 participants.
- What's involved
- You would undergo blood sample collection, bone marrow biopsies, and PET-CT scans. You would also take nemtabrutinib by mouth daily and receive rituximab intravenously (through a vein) for up to 6 cycles, followed by maintenance treatment for up to 24 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The complete response rate will be measured for up to 5.5 years.
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NCT06572618
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~27 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow BiopsyNemtabrutinibPositron Emission Tomography and Computed Tomography ScanRituximab
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response rate
Measured over Up to 5.5 years
Conditions
Where it's being run
2 sites across 1 statesCalifornia2
Study leadership
- Alexey V Danilov · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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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.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative.
Assent, when appropriate, will be obtained per institutional guidelines
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Diagnosis of MCL established by histologic assessment including one of the following:
Immunohistochemistry of the biopsy
Flow cytometry of the biopsy
Requiring treatment for MCL, and for which no prior systemic anticancer therapies have been received
Local radiotherapy not exceeding a total dose of 20 gray (Gy) at least 2 weeks prior the first dose of study therapy is allowed
Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL.
Asymptomatic patients with blastoid or pleomorphic variant can be enrolled
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (as defined by Lugano Classification for non hodgkin's lymphoma \[NHL\])
Without bone marrow involvement: absolute neutrophil count (ANC) ≥ 1,000/mm\^3, with bone marrow involvement: ANC ≥ 500/mm\^3
NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
Without bone marrow involvement: platelets ≥ 75,000/mm\^3 with bone marrow involvement: platelets ≥ 30,000/mm\^3
NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN
Aspartate aminotransferase (AST) ≤ 2.5 x ULN
Alanine aminotransferase (ALT) ≤ 2.5 x ULN
Serum creatinine ≤ 1.5 × ULN OR creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin time (PT) ≤ 1.5 × ULN, if on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
If not receiving anticoagulants: activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, if on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) OR
If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable. Patients with occult or prior HBV infection (defined as negative hepatitis B surface antigen \[HBsAg\] and positive hepatitis B core antibody \[HBcAb\]) may be included if HBV deoxyribonucleic acid (DNA) is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment
Participants with HIV are eligible if they meet ALL the following:
CD4 count \> 350 cells/uL at screening
The HIV viral load is below the detectable level as per locally available testing
Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry
NOTE: ART includes drugs, which are NOT strong CYP3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study).
HIV screening tests are not required unless:
Known history of HIV infection
As mandated by local health authority
Are compliant with their ART NOTE: If the participant has had an AIDS defining opportunistic infection in the past 12 months prior to screening, they are not eligible to be included in the study
Person of childbearing potential (POCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Participants assigned male sex at birth:
Nemtabrutinib: 12 days
Rituximab: 3 months
Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR
Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:
Uses a penile/external condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak.
Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use penile/external condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.
Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed
Participants assigned female sex at birth:
Is not a person of childbearing potential (POCBP) OR
Is a POCBP and:
Uses a contraceptive method that is highly effective (with a failure rate of \< 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:
Nemtabrutinib: 1 month
Rituximab: 12 months
The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.
Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib.
Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy
Exclusion
Chronic systemic corticosteroid use \> 20 mg/day of prednisone or equivalent. Patients who received corticosteroid treatment with ≤ 20 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to day 1 of cycle 1. Patients may have received a brief (≤ 14 days) course of systemic steroids (≤ 100 mg prednisone equivalent per day) prior to initiation of study therapy for control of lymphoma-related symptoms
History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding
Unstable cardiac disease as defined by one of the following:
Acute myocardial infarction (MI) within the past 6 months
NYHA (New York Heart Association) heart failure class III-IV
Unstable angina (angina symptoms at rest) or new-onset angina (begun within the last 3 months)
Corrected QT (QTc) prolongation (defined as a Fridericia's corrected QT interval \[QTcF\] \> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
Positive for hepatitis C virus (HCV) virus by polymerase chain raction (PCR) at screening. Testing only required if the hepatitis (hep) C antibody is positive
AIDS-defining opportunistic infection in the past 12 months prior to screening
Known allergy/sensitivity (≥ grade 3) to nemtabrutinib or any of the excipients; history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents
Clinically significant uncontrolled illness
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment
Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
Other active malignancy. Exceptions include malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of protocol therapy; adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease; adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease; asymptomatic prostate cancer managed with "watch and wait" strategy
POCBP: Pregnant or breastfeeding
Patients with gastrointestinal dysfunction and/or clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with drug absorption (e.g., gastric bypass surgery, gastrectomy)
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Complete response rateUp to 5.5 years
Defined as the proportion of response-evaluable participants that achieve a best response of complete response (CR) at any time on the study prior to any disease progression or start of other anti-lymphoma therapy. Will be estimated among response-evaluable participants along with the 95% exact binomial confidence interval.