Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
- Conditions
- Mantle Cell Lymphoma
- Registration Number
- NCT06572618
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria:<br><br> - Documented informed consent of the participant and/or legally authorized<br> representative.<br><br> - Assent, when appropriate, will be obtained per institutional guidelines<br><br> - Age: = 18 years<br><br> - Eastern Cooperative Oncology Group (ECOG) = 2<br><br> - Diagnosis of MCL established by histologic assessment including one of the<br> following:<br><br> - Immunohistochemistry of the biopsy<br><br> - Flow cytometry of the biopsy<br><br> - Requiring treatment for MCL, and for which no prior systemic anticancer therapies<br> have been received<br><br> - Local radiotherapy not exceeding a total dose of 20 gray (Gy) at least 2 weeks<br> prior the first dose of study therapy is allowed<br><br> - Laboratory, radiographic, physical exam findings and/or symptoms attributable to<br> MCL.<br><br> - Asymptomatic patients with blastoid or pleomorphic variant can be enrolled<br><br> - Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (as<br> defined by Lugano Classification for non hodgkin's lymphoma [NHL])<br><br> - Without bone marrow involvement: absolute neutrophil count (ANC) = 1,000/mm^3, with<br> bone marrow involvement: ANC = 500/mm^3<br><br> - NOTE: Growth factor is not permitted within 7 days of ANC assessment unless<br> cytopenia is secondary to disease involvement<br><br> - Without bone marrow involvement: platelets = 75,000/mm^3 with bone marrow<br> involvement: platelets = 30,000/mm^3<br><br> - NOTE: Platelet transfusions are not permitted within 7 days of platelet<br> assessment unless cytopenia is secondary to disease involvement<br><br> - Total bilirubin = 1.5 × upper limit of normal (ULN) OR direct bilirubin = ULN for<br> participants with total bilirubin levels > 1.5 × ULN<br><br> - Aspartate aminotransferase (AST) = 2.5 x ULN<br><br> - Alanine aminotransferase (ALT) = 2.5 x ULN<br><br> - Serum creatinine = 1.5 × ULN OR creatinine clearance of = 30 mL/min per 24 hour<br> urine test or the Cockcroft-Gault formula<br><br> - If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin<br> time (PT) = 1.5 × ULN, if on anticoagulant therapy: PT must be within therapeutic<br> range of intended use of anticoagulants<br><br> - If not receiving anticoagulants: activated partial thromboplastin time (aPTT) = 1.5<br> × ULN, if on anticoagulant therapy: aPTT must be within therapeutic range of<br> intended use of anticoagulants<br><br> - Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen<br> negative) OR<br><br> - If seropositive for HBV or HCV, nucleic acid quantitation must be performed.<br> Viral load must be undetectable. Patients with occult or prior HBV infection<br> (defined as negative hepatitis B surface antigen [HBsAg] and positive hepatitis<br> B core antibody [HBcAb]) may be included if HBV deoxyribonucleic acid (DNA) is<br> undetectable, if they are willing to undergo DNA testing on day 1 of every<br> cycle and every three months for at least 12 months after the last cycle of<br> study treatment<br><br> - Participants with HIV are eligible if they meet ALL the following:<br><br> - CD4 count > 350 cells/uL at screening<br><br> - The HIV viral load is below the detectable level as per locally available<br> testing<br><br> - Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior<br> to study entry<br><br> - NOTE: ART includes drugs, which are NOT strong CYP3A4 inducers<br> (participants receiving ART that are strong CYP3A4 inducers are not<br> eligible to be included in the study).<br><br> - HIV screening tests are not required unless:<br><br> - Known history of HIV infection<br><br> - As mandated by local health authority<br><br> - Are compliant with their ART NOTE: If the participant has had an AIDS defining<br> opportunistic infection in the past 12 months prior to screening, they are not<br> eligible to be included in the study<br><br> - Person of childbearing potential (POCBP): negative urine or serum pregnancy test. If<br> the urine test is positive or cannot be confirmed as negative, a serum pregnancy<br> test will be required<br><br> - Participants assigned male sex at birth:<br><br>If capable of producing sperm, the participant agrees to the following during the<br>intervention period and for at least the time needed to eliminate each study intervention<br>after the last dose of study intervention. The length of time required to continue<br>contraception for each study intervention is:<br><br> - Nemtabrutinib: 12 days<br><br> - Rituximab: 3 months<br><br> - Abstains from penile-vaginal intercourse as their preferred and usual lifestyle<br> (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR<br><br> - Uses contraception as detailed below unless confirmed to be azoospermic<br> (vasectomized or secondary to medical cause, documented from the site personnel's<br> review of the participant's medical records, medical examination, or medical history<br> interview) as detailed below:<br><br> - Uses a penile/external condom plus nonparticipant of childbearing potential who is<br> not currently pregnant and should also be advised of the benefit for that partner to<br> use an additional method of contraception, as a condom may break or leak.<br><br> - Note: Participants capable of producing ejaculate whose partner is pregnant or<br> breastfeeding must agree to use penile/external condom during each episode of<br> sexual activity in which the partner is at risk of drug exposure via ejaculate.<br><br> - Contraceptive use by participants capable of producing sperm should be consistent<br> with local regulations regarding the methods of contraception for those<br> participating in clinical studies. If the contraception requirements in the local<br> label for any of the study interventions are more stringent than the requirements<br> above, the local label requirements are to be followed<br><br> - Participants assigned female sex at birth:<br><br>A participant assigned female sex at birth is eligible to participate if not pregnant or<br>breastfeeding, and at least one of the following conditions applies:<br><br> - Is not a person of childbearing potential (POCBP) OR<br><br> - Is a POCBP and:<br><br> - Uses a contraceptive method that is highly effective (with a failure rate of <<br> 1% per year), with low user dependency, or is abstinent from penile-vaginal<br> intercourse as their preferred and usual lifestyle (abstinent on a long-term<br> and persistent basis), during the intervention period and for at least the time<br> needed to eliminate each study intervention after the last dose of study<br> intervention. The length of time required to continue contraception for each<br> study intervention is:<br><br> - Nemtabrutinib: 1 month<br><br> - Rituximab: 12 months<br><br> - The investigator should evaluate the potential for contraceptive method failure<br> (ie, noncompliance, recently initiated) in relationship to the first dose of<br> study intervention. Contraceptive use by POCBPs should be consistent with local<br> regulations regarding the methods of contraception for those participating in<br> clinical studies. If the contraception requirements in th
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate
- Secondary Outcome Measures
Name Time Method Overall response rate;Progression free survival;Overall survival;Duration of response;Incidence of adverse events