RecruitingPhase 2NCT06504199

Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma

A Prospective, Open-Label, Single-Arm Study of Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle Cytarabine in First-Line Treatment of Mantle Cell Lymphoma

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

39 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Mantle Cell Lymphoma

Summary

This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma (MCL) . The investigators propose ZGR followed by a short cycle of Obinutuzumab and cytarabine could be an effective first-line treatment for MCL.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — obinutuzumab, zanubrutinib, and lenalidomide — followed by a short course of obinutuzumab with cytarabine, for patients newly diagnosed with mantle cell lymphoma, a type of blood cancer. Researchers want to find out if this combination is effective and safe without requiring an immediate bone marrow transplant. **You may be eligible if...** - You are 18–80 years old with newly confirmed mantle cell lymphoma - You have not yet received any treatment for this cancer - You are in reasonably good health (ECOG score 0–2) - Your heart, blood, kidney, and liver function are adequate - You are not pregnant and willing to use contraception **You may NOT be eligible if...** - You have already started any systemic treatment for mantle cell lymphoma - You have severe heart problems - You are pregnant or breastfeeding - Your blood counts or organ function do not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObinutuzumab

No dose adjustment of Obinutuzumab is allowed.

DRUGZanubrutinib

Zanubrutinib was allowed to be titrated to 80 mg bid or 80 mg qd

DRUGLenalidomide

Lenalidomide was allowed to be titrated to 15 mg/day (induction phase) or 5 mg/day (maintenance phase).

DRUGCytarabine

The specific dose is determined by the investigator according to the actual situation of the patient.

BIOLOGICALCAR-T

zanubrutinib in combination with lenalidomide was allowed for maintenance treatment in high-risk patients for 1 year and zanubrutinib for 2 years after recovery of hemogram 2 months after CAR-T. High-risk Patients with any of the following conditions: Mantle cell lymphoma International Prognostic Index (MIPI-c) high-risk, blastic/pleomorphic type, TP53 mutation/deletion, CDKN2A deletion, MYC amplification/translocation, or incomplete response at induction stage; Non-high-risk group: no high-risk features.

Locations(2)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT06504199

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