Clinical Trials Logo

Clinical Trial Summary

This phase II trial tests how well mosunetuzumab and polatuzumab vedotin works in treating patients with grade 1-3a follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Giving mosunetuzumab and polatuzumab vedotin may kill more cancer cells in patients with relapsed or refractory grade 1-3a follicular lymphoma.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of mosunetuzumab plus polatuzumab vedotin in patients with relapsed/refractory (R/R) follicular lymphoma (FL). (Safety lead-in) II. Estimate the complete response (CR) rate to mosunetuzumab plus polatuzumab vedotin in R/R FL patients. (Phase II) SECONDARY OBJECTIVES: I. Estimate the overall response rate (ORR), time to first CR, time to best response, duration of response (DOR), duration of response among CR (DORC), progression-free survival (PFS), overall survival (OS), and quality of life (QOL) in R/R FL patients treated with mosunetuzumab plus polatuzumab vedotin. II. Evaluate the toxicity of mosunetuzumab plus polatuzumab vedotin for R/R FL. III. Examine the use of tocilizumab for cytokine release syndrome (CRS) in R/R FL patients treated with mosunetuzumab plus polatuzumab vedotin. EXPLORATORY OBJECTIVES: I. Assess baseline and on-treatment biomarkers, and evaluate association with anti-tumor activity and safety. II. Examine the type and incidence of CD20 gene mutations/ downregulation at relapse in R/R FL patients treated with mosunetuzumab plus polatuzumab vedotin. OUTLINE: Patients receive polatuzumab vedotin intravenously (IV) over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive mosunetuzumab subcutaneously (SC) on days 1, 8 and 15 of cycle 1 and day 1 of remaining cycles. Cycles repeat every 21 days for up to 8-17 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up at 30 days and then for 3 years. ;


Study Design


Related Conditions & MeSH terms

  • Lymphoma
  • Lymphoma, Follicular
  • Recurrence
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3a Follicular Lymphoma
  • Refractory Grade 1 Follicular Lymphoma
  • Refractory Grade 2 Follicular Lymphoma
  • Refractory Grade 3a Follicular Lymphoma

NCT number NCT06453044
Study type Interventional
Source City of Hope Medical Center
Contact
Status Not yet recruiting
Phase Phase 2
Start date August 24, 2024
Completion date March 18, 2027

See also
  Status Clinical Trial Phase
Withdrawn NCT04635683 - Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma Phase 1
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT02254772 - A Phase I/II Study of Intratumoral Injection of SD-101 Phase 1/Phase 2
Completed NCT01427881 - Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies Phase 2
Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
Completed NCT01093586 - Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Phase 2
Completed NCT00253630 - Vorinostat in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Completed NCT00006473 - Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
Active, not recruiting NCT01318317 - Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma Phase 1/Phase 2
Active, not recruiting NCT02520791 - Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma Phase 1
Active, not recruiting NCT03583424 - Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Terminated NCT01678443 - Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies Phase 1
Active, not recruiting NCT01815749 - Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma Phase 1
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Withdrawn NCT02281279 - Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT02240719 - Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer Phase 1
Terminated NCT01408043 - Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma N/A
Terminated NCT01397591 - Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma Phase 2