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New treatment option for Mantle Cell Lymphoma
Official title Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT06572618
What this study is testing
What is Nemtabrutinib?
Nemtabrutinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as ARQ 531, ARQ-531.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- Chronic systemic corticosteroid use \> 20 mg/day of prednisone or equivalent. Patients who received corticosteroid treatment with ≤ 20 mg/day of...
- 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)
See the full eligibility criteria
Who can 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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)...
- 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...
- 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 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.