A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Titre officiel

A Phase III, Open-Label, Multicentre, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sommaire:

Il s’agit d’une étude multicentrique et ouverte, portant sur le polatuzumab védotine administré par perfusion intraveineuse (i. v.) en association avec le rituximab, la gemcitabine et l’oxaliplatine (R-GemOx) à des participants atteints d’un lymphome diffus à grandes cellules B (LDGCB) récidivant ou réfractaire. L’étude comprend deux étapes : un volet de prétraitement portant sur l’innocuité et une étude contrôlée menée à répartition aléatoire.

Description de l'essai

Primary Outcome:

  • Stage 1: Percentage of Participants with Adverse Events (AEs)
  • Stage 2: Overall Survival (OS)
Secondary Outcome:
  • Stage 1: Percentage of Participants with Peripheral Neuropathy
  • Stage 1: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions
  • Stage 1: Polatuzumab Vedotin Dose Intensity
  • Stage 1: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline
  • Stage 1: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin Post-Baseline
  • Stage 1: Percentage of Participants with Complete Response (CR)
  • Stage 1: Percentage of Participants with Objective Response (OR)
  • Stage 1: Best Overall Response (BOR)
  • Stage 1: Progression Free Survival (PFS)
  • Stage 1: Overall Survival (OS)
  • Stage 1: Event Free Survival (EFS)
  • Stage 2: Percentage of Participants with Objective Response (OR)
  • Stage 2: Percentage of Participants with Complete Response (CR)
  • Stage 2: Best Overall Response (BOR)
  • Stage 2: Progression Free Survival (PFS)
  • Stage 2: Duration of Response (DOR)
  • Stage 2: Event Free Survival (EFS)
  • Stage 2: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score
  • Stage 2: Time to Deterioration in Physical Functioning and Fatigue
  • Stage 2: Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score
  • Stage 2: Time to Progression in Lymphoma Symptoms According to FACT-Lym Subscale
  • Stage 2: Change from Baseline in Peripheral Neuropathy According to FACT/GOG-NTX-12 Subscale Score
  • Stage 2: Percentage of Participants with Adverse Events (AEs)
  • Stage 2: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions
  • Stage 2: Polatuzumab Vedotin Dose Intensity
  • Stage 2: Percentage of Participants with Peripheral Neuropathy
  • Stage 2: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline
  • Stage 2: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin Post-Baseline
The safety run-in stage (Stage 1) will assess the safety of polatuzumab vedotin plus rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) in 10 participants. The randomized controlled trial (RCT) (Stage 2) will compare Pola-R-GemOx versus R-GemOx in 206 participants.

Voir cet essai sur ClinicalTrials.gov

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