A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma (NCT05171647)
π©Ί Plain-English Summary (8th-Grade Level)
This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (34 items).
Location: City of Hope Cancer Center β Duarte, California
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnant or breast feeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months after the final dose of tocilizumab, as applicable
- Inability to comply with protocol-mandated activity restrictions
- Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, or R-GemOx or Gem-Ox
- Prior treatment with polatuzumab vedotin, with the following exceptions: participants who have a documented response (partial response or complete response) to polatuzumab vedotin and an absence of PD within 12 months from the last dose of polatuzumab vedotin; participants who received up to 2 doses of a polatuzumab vedotin-containing regimen as bridging to CAR-T therapy, and either has a documented disease control (stable disease, partial response, or complete response), or were not assessed for response following treatment with polatuzumab vedotin
- Contraindication to any component of the study treatment
- Grade \> 1 peripheral neuropathy
- Participants with Grade \> 1 persistent toxicity related to prior anti-lymphoma treatment (except for alopecia and anorexia, or other toxicities not considered a safety risk for the participant per investigator's judgment)
- Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugates or antibody-drug conjugates (ADCs) within 4 weeks before the first dose of study treatment
- Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of study treatment
- Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
- ASCT within 100 days prior to the first study treatment administration
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (51 Sites)
- City of Hope Cancer Center β Duarte, California
- St. Luke's Hospital β Chesterfield, Missouri
- Ascension Seton Infusion Center β Austin, Texas
- MD Anderson Cancer Center β Houston, Texas
- Hospital Aleman β Buenos Aires,
- Instituto Alexander Fleming β Buenos Aires,
- FUNDALEU β Buenos Aires,
- Hospital Italiano de Buenos Aires β Ciudad Autonoma Buenos Aires,
- Hospital Erasto Gaertner β Curitiba, ParanΓ‘
- Hospital das Clinicas - UFRGS β Porto Alegre, Rio Grande do Sul
- Hospital das ClΓnicas FMRP-USP β RibeirΓ£o Preto, SΓ£o Paulo
- Hospital Sao Jose β SΓ£o Paulo, SΓ£o Paulo
- D'or Instituto de Pesquisa e EducaΓ§Γ£o β SΓ£o Paulo,
- Hamilton Health Sciences - Juravinski Cancer Centre β Hamilton, Ontario
- Princess Margaret Hospital β Toronto, Ontario
- Chum Hopital Notre Dame β Montreal, Quebec
- Sichuan Cancer Hospital β Chengdu,
- Fujian Medical University Union Hospital β Fuzhou,
- Cancer Center, Sun Yat-sen University of Medical Sciences β Guangzhou,
- Tianjin Cancer Hospital β Tianjin,
- Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech β Wuhan,
- Henan Cancer Hospital β Zhengzhou,
- Soroka Medical Center β Beersheba,
- Ichilov Sourasky Medical Center β Tel Aviv,
- Kyushu University Hospital β Fukuoka,
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.