Mantle Cell LymphomaPhase 2NCT06572618
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
A Phase 2 study testing Biospecimen Collection, Bone Marrow Biopsy and Nemtabrutinib in people with Mantle Cell Lymphoma, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
This phase II trial tests how well nemtabrutinib works with rituximab for the treatment of patients with mantle cell lymphoma. Nemtabrutinib is in a class of medications called kinase inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Biospecimen Collection, Bone Marrow Biopsy and Nemtabrutinib
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jan 2025to 8 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- If capable of producing sperm, the participant agrees to the following 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: 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:
- A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Alexey V. Danilov, 626-218-2405, adanilov@coh.org
Alexey V. Danilov
- Not yet recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Alexey V. Danilov, 626-218-2405, adanilov@coh.org
Alexey V. Danilov
About this study
Official title: A Phase 2 Study of BTK Inhibitor Nemtabrutinib in Combination With Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
This phase II trial tests how well nemtabrutinib works with rituximab for the treatment of patients with mantle cell lymphoma. Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nemtabrutinib with rituximab may kill more cancer cells in patients with mantle cell lymphoma.
Read the detailed description
PRIMARY OBJECITVE:
- To evaluate the efficacy (complete response rate) of nemtabrutinib and rituximab (Nem-R) in patients with treatment-naïve mantle cell lymphoma (MCL).
SECONDARY OBJECITVES:
- To evaluate objective response rate (ORR), median progression-free survival (PFS), overall survival (OS) and duration of response (DOR).
II. To evaluate safety and tolerability of Nem-R in patients with treatment-naïve MCL.
EXPLORATORY OBJECITVES:
- To conduct preliminary assessment of the predictive value of minimal residual disease (MRD) in MCL treated with a novel regimen.
II. To explore immune cell populations in patients treated with Nem-R. III. To explore mechanisms of resistance to Nem-R therapy in MCL. IV. To estimate the second PFS after salvage therapy for patients who progress after Nem-R therapy.
OUTLINE:
INDUCTION: Patients receive nemtabrutinib orally (PO) once per day (QD) on days 1-28 of each cycle and rituximab intravenously (IV) on days 1, 8, 15 and 22 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on day 1 of event numbered cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally continue to receive nemtabrutinib PO QD in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow biopsy during screening and may undergo throughout the trial and positron emission tomography-computed tomography (PET-CT) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, then every 3 months for the first 2 years and every 6 months for the third year for patients in remission at the end of treatment or every 6 months for patients who end response follow up.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Biospecimen Collection, Bone Marrow Biopsy, Nemtabrutinib, Positron Emission Tomography and Computed Tomography Scan, Rituximab
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
NemtabrutinibDrug
Also called ARQ 531, ARQ-531, ARQ531, Bruton's Tyrosine Kinase Inhibitor ARQ 531
Given PO
Positron Emission Tomography and Computed Tomography ScanProcedure or surgery
Also called PET-CT Scan, PET/CT SCAN, Positron Emission Tomography/Computed Tomography
Undergo PET-CT scan
RituximabBiological
Also called ABP 798, BI 695500, BI-695500, BI695500
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nemtabrutinib and rituximab) | Experimental | INDUCTION: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on days 1, 8, 15 and 22 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on day 1 of event numbered cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally continue to receive nemtabrutinib PO QD in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow biopsy during screening and may undergo throughout the trial and PET-CT scan and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Drug: Nemtabrutinib; Procedure: Positron Emission Tomography and Computed Tomography Scan; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
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.
Measured: Up to 5.5 years
Secondary outcomes (5)
Overall response rate
Defined as the proportion of response-evaluable participants that achieve a best response of either CR or partial response (PR) 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.
Measured: Up to 5.5 years
Progression free survival
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Measured: From start of protocol treatment to disease relapse/progression, start of other anti-lymphoma therapy, or death due to any cause, whichever occurs earlier, up to 5.5 years
Overall survival
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Measured: From start of protocol treatment to death due to any cause, up to 5.5 years
Duration of response
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Measured: From the first achievement of PR or CR to time of progressive disease, start of non-protocol anti-lymphoma therapy, or death, whichever earlier, up to 5.5 years
Incidence of adverse events
Toxicities/adverse events will be recorded and severity assessment will be the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Toxicities will be summarized by time of onset, type, severity, and attribution.
Measured: Up to 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start22 Jan 2025
- Primary completion8 Jan 2027 (estimated)
- Study completion8 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexey V Danilov, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572618
- Sponsor's protocol ID
- 23421
- Other IDs
- NCI-2024-06740, 23421, P30CA033572
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of BTK Inhibitor Nemtabrutinib in Combination With Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06572618
- Acronym / sponsor ID
- 23421
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 8 Jan 2027 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial tests how well nemtabrutinib works with rituximab for the treatment of patients with mantle cell lymphoma. Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nemtabrutinib with rituximab may kill more cancer cells in patients with mantle cell lymphoma.
Detailed description
PRIMARY OBJECITVE:
- To evaluate the efficacy (complete response rate) of nemtabrutinib and rituximab (Nem-R) in patients with treatment-naïve mantle cell lymphoma (MCL).
SECONDARY OBJECITVES:
- To evaluate objective response rate (ORR), median progression-free survival (PFS), overall survival (OS) and duration of response (DOR).
II. To evaluate safety and tolerability of Nem-R in patients with treatment-naïve MCL.
EXPLORATORY OBJECITVES:
- To conduct preliminary assessment of the predictive value of minimal residual disease (MRD) in MCL treated with a novel regimen.
II. To explore immune cell populations in patients treated with Nem-R. III. To explore mechanisms of resistance to Nem-R therapy in MCL. IV. To estimate the second PFS after salvage therapy for patients who progress after Nem-R therapy.
OUTLINE:
INDUCTION: Patients receive nemtabrutinib orally (PO) once per day (QD) on days 1-28 of each cycle and rituximab intravenously (IV) on days 1, 8, 15 and 22 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on day 1 of event numbered cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally continue to receive nemtabrutinib PO QD in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow biopsy during screening and may undergo throughout the trial and positron emission tomography-computed tomography (PET-CT) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, then every 3 months for the first 2 years and every 6 months for the third year for patients in remission at the end of treatment or every 6 months for patients who end response follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (nemtabrutinib and rituximab) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Marrow Biopsy, Drug: Nemtabrutinib, Procedure: Positron Emission Tomography and Computed Tomography Scan, Biological: RituximabINDUCTION: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on days 1, 8, 15 and 22 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on day 1 of event numbered cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally continue to receive nemtabrutinib PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy during screening and may undergo throughout the trial and PET-CT scan and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (54 listed)
- Documented informed consent of the participant and/or legally authorized representative.
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Diagnosis of MCL established by histologic assessment including one of the following:
- Requiring treatment for MCL, and for which no prior systemic anticancer therapies have been received
Key exclusion criteria (18 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (nemtabrutinib and rituximab) |
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, Biopsy, Bone MarrowUndergo bone marrow biopsy | Procedure or surgery | Treatment (nemtabrutinib and rituximab) |
| NemtabrutinibAlso: ARQ 531, ARQ-531, ARQ531, Bruton's Tyrosine Kinase Inhibitor ARQ 531Given PO | Drug | Treatment (nemtabrutinib and rituximab) |
| Positron Emission Tomography and Computed Tomography ScanAlso: PET-CT Scan, PET/CT SCAN, Positron Emission Tomography/Computed TomographyUndergo PET-CT scan | Procedure or surgery | Treatment (nemtabrutinib and rituximab) |
| RituximabAlso: ABP 798, BI 695500, BI-695500, BI695500Given IV | Biological | Treatment (nemtabrutinib and rituximab) |
Primary outcome
Complete response rate
Time frame: Up 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.
5 secondary outcomes
Overall response rate
Time frame: Up to 5.5 years
Progression free survival
Time frame: From start of protocol treatment to disease relapse/progression, start of other anti-lymphoma therapy, or death due to any cause, whichever occurs earlier, up to 5.5 years
Overall survival
Time frame: From start of protocol treatment to death due to any cause, up to 5.5 years
Duration of response
Time frame: From the first achievement of PR or CR to time of progressive disease, start of non-protocol anti-lymphoma therapy, or death, whichever earlier, up to 5.5 years
Incidence of adverse events
Time frame: Up to 5.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexey V Danilov principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Bone Marrow Biopsy and Nemtabrutinib in people with Mantle Cell Lymphoma, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 54 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: Up to 5.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.