New drug cocktail shows promise against rare blood cancer
NCT ID NCT06504199
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (obinutuzumab, zanubrutinib, and lenalidomide) followed by a short course of chemotherapy (cytarabine) in 39 adults newly diagnosed with mantle cell lymphoma, a rare blood cancer. The goal is to see if this approach can shrink or eliminate tumors effectively. Participants must not have had prior treatment for this cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 80 years, male or female; 2. Patients with pathologically (histologically or cytologically) confirmed MCL and at least one measurable lesion by Lugano criteria; 3. No prior systemic therapy for MCL; 4. Eastern Cooperative Oncology Group (ECOG) score of 0-2 points; 5. Normal function of vital organs, i.e. meeting the following criteria: a) Blood routine examination must be in accordance with (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days): i. Absolute neutrophil count (ANC) ≥ 1 × 10^9/L; ii. Platelet count (PLT) ≥ 75 × 10^9/L; b) Chemistry panel must meet the following criteria: i. Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN); ii. Glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST) ≤ 2.0 × ULN iii. Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula); c) Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; 6. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the start of study medication and are willing to use a medically recognized highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) during the study and within 6 months after the last dose of study drug; male subjects with partners of childbearing potential should be surgically sterile or agree to use an effective method of contraception during the study and within 6 months after the last dose of study drug; 7. The subjects voluntarily participate in the study and sign the informed consent form. They have good compliance and cooperate in the follow-up. Exclusion Criteria: 1. Known central nervous system disease such as brain or meninges, including central nervous system lymphoma. 2. Congestive heart failure, Class III or IV (New York Heart Association, NYHA); 3. Other primary malignancies within the last 3 years (except non-melanoma skin cancer, curatively treated localized prostate cancer, carcinoma in situ of the cervix, or squamous epithelial endothelial lesions on PAP smear) 4. Previous use of investigational drugs; 5. Any active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug; 6. Use of immunosuppressive agents, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 20 mg/day prednisone or its equivalent) within 7 days prior to the first dose of study drug 7. Allergic reactions, anaphylactic reactions and adverse drug reactions 1. Severe allergic reactions to other monoclonal antibodies; 2. Allergy or intolerance to infusion; 3. Patients with a history of serious allergy to the investigational drug or its preventive medication; 8. Physical examination and laboratory findings 1. Patients with congenital or acquired immunodeficiency, such as active hepatitis B virus (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of detection of the analytical method) or combined hepatitis B and C co-infection; 2. Pregnant or lactating women; patients with fertility are unwilling or unable to take effective contraceptive measures; 3. Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 9. Any condition that, in the opinion of the investigator, may jeopardize the subject or may render the subject unable to meet or perform the study requirements; 10. Other conditions that the investigator considers inappropriate for entry into this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
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Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
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Other studies related to the condition(s) this trial covers.
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