Clinical Trials Logo

Clinical Trial Summary

This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib. The patients will be Randomized as follows: Arm A - Experimental arm: • Mosunetuzumab-Lenalidomide Arm B - Comparator arms ( Investigator Choices): - Rituximab-Lenalidomide - Rituximab-Bendamustine - Rituximab-CHOP


Clinical Trial Description

This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib. Patients are stratified according to MZL subtypes and time to progression of disease after first-line within 2 years (POD24) < 2 years or > 2 years. Mosunetuzumab will be administered sub-cutaneously (SC) (21 days first cycle, then 28 days next cycles) and Lenalidomide will be given PO 20 mg/day from Day 1 to Day 21 from cycles C2 to C6. For each patient, investigator choice had to be decided before randomization between Rituximab-Lenalidomide and Rituximab-chemotherapy (R-Bendamustine or R-CHOP). The primary efficacy endpoint for comparison is the Progression-free survival (PFS) as determined by investigator (Lugano criteria 2014). Secondary objectives include CR24 as determined by investigator (at 24 months) according to Lugano criteria 2014 and by central review based on PET result, Overall response rate (ORR) and CR other than CR24 as determined by investigator, or by central review based on PET result according to Lugano Criteria 2014. 260 patients are planned to be enrolled in France, Belgium, Germany, Italy and Portugal ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06006117
Study type Interventional
Source The Lymphoma Academic Research Organisation
Contact Karima BRAHAMI
Phone 0634533784
Email karima.brahami-aissou@lysarc.org
Status Recruiting
Phase Phase 3
Start date September 5, 2023
Completion date September 2032

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03078855 - A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma Phase 3
Active, not recruiting NCT04082936 - A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Recruiting NCT04883437 - Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas Phase 2
Active, not recruiting NCT03697512 - MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas Phase 2
Terminated NCT00772668 - Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL N/A
Terminated NCT04189952 - Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Recruiting NCT05006716 - A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Phase 1/Phase 2
Terminated NCT03919175 - Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma Phase 2
Recruiting NCT06026319 - CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma Phase 1
Active, not recruiting NCT03133221 - 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Phase 2
Terminated NCT01500538 - A Pilot Study of Oral Vorinostat Plus Oral Eltrombopag Support in Patients With Lymphoma (VEIL) Phase 2
Not yet recruiting NCT05923502 - (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
Active, not recruiting NCT04646395 - Study of Acalabrutinib and Tafasitamab in MZL Patients Phase 2
Recruiting NCT04116437 - Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment Phase 2
Completed NCT02242045 - Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL) Phase 1
Completed NCT02927964 - TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma Phase 1/Phase 2
Recruiting NCT04072458 - A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies Phase 1
Completed NCT03364231 - Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma Phase 2
Active, not recruiting NCT02996773 - Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine Phase 1