NCT05992597

ZR2 Sequential Immunochemotherapy for Newly Treated MCL

Prospective, Single-arm, Single-center, Phase II Clinical Study of Rituximab, Lenalidomide, Zebutinib Combined Regimen Followed by Sequential Immunochemotherapy in the Treatment of Initially Treated Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with newly diagnosed MCL were treated with ZR2 regimen for 3 cycles, followed by 3 cycles of immunochemotherapy, and zebrutinib maintenance therapy for 2 years after the end of induction therapy, in order to improve the remission rate and prognosis of patients with induction therapy.

Detailed description

This is a prospective, single-arm, multicenter, Phase II clinical study evaluating sequential immunochemotherapy followed by rituximab, lenalidomide, and zebutinib combined with or without autologous hematopoietic stem cell transplantation followed by zebutinib maintenance therapy for initial treatment of capsular cell lymphoma. There are three stages: screening, treatment and follow-up. The screening period was 28 days before the first administration. Treatment period: Enrolled subjects first received 3 cycles of rituximab, lenalidomide, zebutinib without chemotherapy (21 days for one cycle), followed by 3 cycles of RDHAP immunochemotherapy (21 days for one cycle); All patients were assessed with interim Positron Emission Tomography (iPET) after 3 cycles of rituximab, lenalidomide, and zebutinib without chemotherapy. All patients will continue to receive 3 cycles Of RDHAP, followed by Treatment End Of Positron Emission Tomography. For patients who have achieved complete metabolic response (CMR) or partial metabolic response (PMR), autologous hematopoietic stem cell transplantation (ASCT) can be performed as consolidation therapy after the researchers evaluate their physical status and their personal wishes. 3 months after ASCT, PET will be reviewed for efficacy evaluation after transplantation. Zebutinib maintenance therapy was started 2 months after transplantation for 2 years. For patients without ASCT, zebutinib maintenance therapy was started directly for 2 years. The follow-up period was entered after the end of maintenance therapy. Efficacy was evaluated using Lugano2014 criteria. Patients with disease progression during non-chemotherapy treatment were directly entered into RDHAP immunochemotherapy, and patients with disease progression during immunochemotherapy were directly removed from the group and entered second-line treatment. Objective effective rate, safety index and survival data of patients were observed during the experiment. Subjects will enter the follow-up period after the study treatment is discontinued or the treatment period has been completed.

Conditions

• Rituximab, Lenalidomide, Zebutinib ，Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	ZR2 RDHAP	ZR2:Rituximab 375mg/m2, D1, Lenalidomide 24mg qd D1-14, zebutinib 160mg bid RDHAP:Rituximab 375mg/m2 D0, dexamethasone 40mg D1-4, cytarabine 2g/m2 q12h D2, cisplatin 25mg/m2 D1-3.

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-08-01
• Completion: 2026-12-01
• First posted: 2023-08-15
• Last updated: 2023-09-21

Locations

1 site across 1 country: China