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RECRUITING
NCT06504199
PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2024-07-18

Completion Date

2028-12-31

Last Updated

2024-08-09

Healthy Volunteers

No

Interventions

DRUG

Obinutuzumab

No dose adjustment of Obinutuzumab is allowed.

DRUG

Zanubrutinib

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

DRUG

Lenalidomide

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

DRUG

Cytarabine

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

BIOLOGICAL

CAR-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