Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06504199 | Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma | PHASE2 | ACTIVE NOT_RECRUITING | 39 | — | — | Jul 18, 2024 | Dec 31, 2028 | May 13, 2026 | 2 | China |
defined as the proportion of patients with complete response as assessed by response to induction therapy using the 2014 Lugano criteria.
| Arm | Type | Description |
|---|---|---|
| ZGR followed short cycle of Obinutuzumab and Cytarabine | EXPERIMENTAL | All patients were treated with ZGR regimen for 6 cycles after enrollment, followed by 3 cycles of Obinutuzumab and Cytarabine in 28-day cycles. Obinutuzumab: 1000 mg, intravenous drip, administered on d1, d8 and d15 of the first cycle, and administered on the first day of each cycle starting from the second cycle. Zanubrutinib: 160 mg, bid, continuous oral. Lenalidomide: 20 mg/d, qd, oral, d1-d21.Cytarabine: for young tolerable patients, the dose is 2 g/m2, q12h, intravenous drip, d1-2ND for elderly/intolerant patients, the dose is 500 mg/m2, q12h, intravenous drip, completed 2-3 hours, d1-3. The specific dose is determined by the investigator according to the actual situation of the patient. Zanubrutinib for 2 years combination with Lenalidomide for 1 year was used for maintenance treatment in non-high-risk patients and in high-risk patients after recovery of hemogram 2 months after CAR-T. |
| Name | Type | Description |
|---|---|---|
| Obinutuzumab | DRUG | No dose adjustment of Obinutuzumab is allowed. |
| Zanubrutinib | DRUG | Zanubrutinib was allowed to be titrated to 80 mg bid or 80 mg qd |
| Lenalidomide | DRUG | Lenalidomide was allowed to be titrated to 15 mg/day (induction phase) or 5 mg/day (maintenance phase). |
| Cytarabine | DRUG | The specific dose is determined by the investigator according to the actual situation of the patient. |
| CAR-T | BIOLOGICAL | 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. |
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; ...