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

PHASE2RecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

July 18, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Mantle Cell Lymphoma
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.

Trial Locations (2)

300020

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Tianjin

RECRUITING

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

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER