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New treatment option for Mantle Cell Lymphoma
Official title Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT07261163
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mantle cell lymphoma.
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 is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL.
- 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 to 80
You may be able to join if
- Age between 18 and 80 years inclusive, both genders are eligible.
- Histologically or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL), with at least one measurable lesion according to Lugano criteria.
- No prior systemic therapy for MCL.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ function, defined as:
You likely can't join if
- Known central nervous system (CNS) involvement, including brain or meningeal lymphoma.
- Congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac dysfunction.
- History of other primary malignancies within the past 3 years, except for non-melanoma skin cancer, localized prostate cancer considered cured...
- Prior treatment with investigational drugs.
- Active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to first administration of study drug.
- Use of immunosuppressive agents within 7 days prior to first administration of study drug, except for intranasal or inhaled corticosteroids, or...
See the full eligibility criteria
- Age between 18 and 80 years inclusive, both genders are eligible.
- Histologically or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL), with at least one measurable lesion according to Lugano criteria.
- No prior systemic therapy for MCL.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ function, defined as:
- Hematologic function (without red blood cell or platelet transfusion, growth factor support, or medication correction within 14 days prior to enrollment):Absolute neutrophil count (ANC) ≥ 1 × 10⁹/L;Platelet count (PLT)...
- Biochemical tests must meet the following criteria:: Total bilirubin ≤ 2.0 × upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN;Creatinine clearance ≥ 30 mL/min...
- Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram.
- Female people of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and must agree to use a highly effective method of contraception (e.g...
- Willing and able to provide written informed consent and comply with the study follow-up requirements.
- Known central nervous system (CNS) involvement, including brain or meningeal lymphoma.
- Congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac dysfunction.
- History of other primary malignancies within the past 3 years, except for non-melanoma skin cancer, localized prostate cancer considered cured, cervical in situ carcinoma, or squamous intraepithelial lesion detected by...
- Prior treatment with investigational drugs.
- Active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to first administration of study drug.
- Use of immunosuppressive agents within 7 days prior to first administration of study drug, except for intranasal or inhaled corticosteroids, or systemic corticosteroids at physiologic doses (i.e., ≤ 20 mg/day prednisone...
- History of hypersensitivity, allergic reactions, or adverse drug reactions:Severe hypersensitivity reaction to monoclonal antibodies;Allergy or intolerance to infusions;History of severe allergy to study drugs or...
- Physical or laboratory findings:Congenital or acquired immunodeficiency, such as active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive HCV antibody and HCV-RNA above lower limit of detection), or co-infection...
- Any condition that, in the investigator's judgment, may impair subject safety or ability to comply with the study protocol.
- Other conditions deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. 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.