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A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (ROMULUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01691898
First received: September 16, 2012
Last updated: August 24, 2017
Last verified: August 2017
September 16, 2012
August 24, 2017
September 26, 2012
March 28, 2017   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohorts C to D] and 24 weeks for Cohorts E, G, and H) ]
  • Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab-Containing Regimens [Arms A and B, Cohorts C to D] [ Time Frame: Baseline up to 12 months after the last dose of study treatment (up to approximately 2 years) ]
  • Duration of Objective Response as Determined by Modified Response and Progression Criteria for NHL: Rituximab-Containing Regimens [Arms A and B, Cohorts C to D] [ Time Frame: First occurrence of response up to relapse or death due to any cause, whichever occurs first (up to approximately 2 years) ]
  • Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic (PET) Assessment as Determined by Independent Review Committee (IRC) per Lugano 2014 Response Criteria:Obinutuzumab-Containing Cohorts (Cohorts E,G and H) [ Time Frame: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks) ]
  • Safety: Incidence of adverse events [ Time Frame: Up to approximately 1 year ]
  • Objective response according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ]
Complete list of historical versions of study NCT01691898 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Pinatuzumab Vedotin [ Time Frame: Pre-infusion (Hour 0) on Day 2 of Cycles 1-4 and every 4th Cycle thereafter; 30 Days after last infusion; 2, 4, and 6 months after treatment completion visit (approximately up to 1.5 years, cycle length = 21 days) ]
  • Percentage of Participants With ATA to Polatuzumab Vedotin [ Time Frame: Day 2 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 on Day 2 of Cycle 1-4 & every 4th Cycle thereafter; 30 Days after last infusion; 2,4,& 6 months after treatment completion visit for rituximab regimen and Pre-infusion Hour 0 on Day 2 of Cycle 1; Pre-infusion Hour 0 on Day 1 of Cycle 2, 4; 30 Days, 8 weeks after last infusion; 3,6 months after treatment completion visit for Cohort E, G, H (approximately up to 1.5 years, Cycle length= 21 Days)
  • Percentage of Participants With ATA to Obinutuzumab [ Time Frame: Pre-infusion Hour 0 on Day 1 of Cycle 1, 2, 4; 30 Days, 8 weeks after last infusion; 3, 6, 12, 18 & 24 months follow-up visits (approximately up to 32 months, Cycle length= 21 Days) ]
  • Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Arms A and B, Cohorts C and D [ Time Frame: Baseline up to disease progression or death within 30 days of last infusion, whichever occurs first (up to approximately 1 year) ]
  • Overall Survival (OS): Arms A and B, Cohorts C and D [ Time Frame: Baseline up to 12 month post-treatment follow-up (up to approximately 2 years) ]
  • Percentage of Participants With CR at EOT Based on Computed Tomography (CT) Assessment as Determined by IRC per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H) [ Time Frame: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks) ]
  • Percentage of Participants With CR at EOT Based on CT Assessment as Determined by Investigator per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H) [ Time Frame: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks) ]
  • Percentage of Participants With OR Based on PET Assessment as Determined by IRC per Lugano 2014 Response Criteria at EOT: Cohort E, G, H [ Time Frame: 6-8 weeks after Day 1 of Cycle 8 (cycle length = 21 days) or last study treatment (maximum up to 27-29 weeks) ]
  • Percentage of Participants With OR Based on PET Assessment as Determined by Investigator per Lugano 2014 Response Criteria at EOT: Cohort E, G, H [ Time Frame: 6-8 weeks after Day 1 of Cycle 8 (cycle length = 21 days) or last study treatment (maximum up to 27-29 weeks) ]
  • Percentage of Participants With OR Based on CT Assessment as Determined by the IRC per Lugano 2014 Response Criteria at EOT: Cohort E, G, H [ Time Frame: 6-8 weeks after Day 1 of Cycle 8 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks) ]
  • Percentage of Participants With OR Based on CT Assessment as Determined by the Investigator per Lugano 2014 Response Criteria at EOT: Cohort E, G, H [ Time Frame: 6-8 weeks after Day 1 of Cycle 8 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks) ]
  • Percentage of Participants With Best OR Based on PET Alone Assessment as Determined by the Investigator per Lugano 2014 Response Criteria During the Study: Cohort E, G, H [ Time Frame: Baseline, between Cycle 4 Day 15 (cycle length = 21 Days) and Cycle 5 Day 1, EOT (6-8 weeks after Day 1 of Cycle 8 or last study treatment), post-treatment follow-up every 6 months until study completion (maximum up to 2 years) ]
  • Percentage of Participants With Best OR Based on CT Alone Assessment as Determined by the Investigator per Lugano 2014 Response Criteria During the Study: Cohort E, G, H [ Time Frame: Baseline, between Cycle 4 Day 15 (cycle length = 21 Days) and Cycle 5 Day 1, EOT (6-8 weeks after Day 1 of Cycle 8 or last study treatment), post-treatment follow-up every 6 months until study completion (maximum up to 2 years) ]
  • Area Under the Concentration-Time Curve (AUC) of Rituximab [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
  • AUC of Polatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0, 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 Cycle 1-4 & every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 Cycle 1 & 3; 30 Days after last infusion; 2, 4 & 6 months after treatment completion visit (Arms A-B, Cohorts C-D) / Pre-infusion Hour 0, 30 minutes post-infusion on Day 2 Cycle 1; Pre-infusion Hour 0, 30 minutes Post-infusion on Day 1 Cycle 2, 4; Day 8, Day 15 Cycle 1; 30, 8 weeks after last infusion; 3, 6 months after treatment completion visit (Cohort E,G,H) (approximately up to 1.5 years, cycle length= 21 Days)
  • AUC of Pinatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months follow-up after last infusion (approximately up to 1.5 years, cycle length= 21 Days)
  • AUC of Obinutuzumab [ Time Frame: Day 1 up to 32 months (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes at end of obinutuzumab infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Pre-infusion on Day 1 of Cycle 2; Pre-infusion & 30 minutes at end of obinutuzumab infusion on Day 1 of Cycle 4; 30 Days, 8 weeks after last infusion; 3, 6, 12, 18 & 24 months follow-up (approximately up to 32 months, Cycle length= 21 Days)
  • Maximum Observed Serum Concentration of Rituximab [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
  • Maximum Observed Plasma Concentration (Cmax) of Polatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0, 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 Cycle 1-4 & every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 Cycle 1 & 3; 30 Days after last infusion; 2, 4 & 6 months after treatment completion visit (Arms A-B, Cohorts C-D) / Pre-infusion Hour 0, 30 minutes post-infusion on Day 2 Cycle 1; Pre-infusion Hour 0, 30 minutes Post-infusion on Day 1 Cycle 2, 4; Day 8, Day 15 Cycle 1; 30, 8 weeks after last infusion; 3, 6 months after treatment completion visit (Cohort E,G,H) (approximately up to 1.5 years, cycle length= 21 Days)
  • Cmax of Pinatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months follow-up after last infusion (approximately up to 1.5 years, cycle length= 21 Days)
  • Maximum Observed Serum Concentration of Obinutuzumab [ Time Frame: Day 1 up to 32 months (detailed timeframe is provided in the OM description) ]
    Pre-infusion (infusion length= 2-6 hours) Hour 0 & 30 minutes at end of obinutuzumab infusion on Day 1 of Cycle 1; Pre-infusion on Day 1 of Cycle 2; Pre-infusion & 30 minutes at end of obinutuzumab infusion on Day 1 of Cycle 4; 30 Days, 8 weeks after last infusion; 3, 6, 12, 18 & 24 months follow-up (approximately up to 32 months, Cycle length= 21 Days)
  • Systemic Clearance (CL) of Rituximab [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion (infusion length= 2-6 hours) Hour 0 & 30 minutes post-infusion on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
  • CL of Polatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0, 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 Cycle 1-4 & every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 Cycle 1 & 3; 30 Days after last infusion; 2, 4 & 6 months after treatment completion visit (Arms A-B, Cohorts C-D) / Pre-infusion Hour 0, 30 minutes post-infusion on Day 2 Cycle 1; Pre-infusion Hour 0, 30 minutes Post-infusion on Day 1 Cycle 2, 4; Day 8, Day 15 Cycle 1; 30, 8 weeks after last infusion; 3, 6 months after treatment completion visit (Cohort E,G,H) (approximately up to 1.5 years, cycle length= 21 Days)
  • CL of Pinatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months follow-up after last infusion (approximately up to 1.5 years, cycle length= 21 Days)
  • CL of Obinutuzumab [ Time Frame: Day 1 up to 32 months (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes at end of obinutuzumab infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Pre-infusion on Day 1 of Cycle 2; Pre-infusion & 30 minutes at end of obinutuzumab infusion on Day 1 of Cycle 4; 30 Days, 8 weeks after last infusion; 3, 6, 12, 18 & 24 months follow-up (approximately up to 32 months, Cycle length= 21 Days)
  • Plasma Decay Half-Life (t1/2) of Rituximab [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
  • t1/2 of Polatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0, 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 Cycle 1-4 & every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 Cycle 1 & 3; 30 Days after last infusion; 2, 4 & 6 months after treatment completion visit (Arms A-B, Cohorts C-D) / Pre-infusion Hour 0, 30 minutes post-infusion on Day 2 Cycle 1; Pre-infusion Hour 0, 30 minutes Post-infusion on Day 1 Cycle 2, 4; Day 8, Day 15 Cycle 1; 30, 8 weeks after last infusion; 3, 6 months after treatment completion visit (Cohort E,G,H) (approximately up to 1.5 years, cycle length= 21 Days)
  • t1/2 of Pinatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months follow-up after last infusion (approximately up to 1.5 years, cycle length= 21 Days)
  • t1/2 of Obinutuzumab [ Time Frame: Day 1 up to 32 months (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes at end of obinutuzumab infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Pre-infusion on Day 1 of Cycle 2; Pre-infusion & 30 minutes at end of obinutuzumab infusion on Day 1 of Cycle 4; 30 Days, 8 weeks after last infusion; 3, 6, 12, 18 & 24 months follow-up (approximately up to 32 months, Cycle length= 21 Days)
  • Volume of Distribution at Steady State (Vss) of Rituximab [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
  • Vss of Polatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0, 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 Cycle 1-4 & every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 Cycle 1 & 3; 30 Days after last infusion; 2, 4 & 6 months after treatment completion visit (Arms A-B, Cohorts C-D) / Pre-infusion Hour 0, 30 minutes post-infusion on Day 2 Cycle 1; Pre-infusion Hour 0, 30 minutes Post-infusion on Day 1 Cycle 2, 4; Day 8, Day 15 Cycle 1; 30, 8 weeks after last infusion; 3, 6 months after treatment completion visit (Cohort E,G,H) (approximately up to 1.5 years, cycle length= 21 Days)
  • Vss of Pinatuzumab Vedotin [ Time Frame: Day 1 up to 1.5 years (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes Post-infusion (infusion length = 30 to 90 minutes) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months follow-up after last infusion (approximately up to 1.5 years, cycle length= 21 Days)
  • Vss of Obinutuzumab [ Time Frame: Day 1 up to 32 months (detailed timeframe is provided in the OM description) ]
    Pre-infusion Hour 0 & 30 minutes at end of obinutuzumab infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Pre-infusion on Day 1 of Cycle 2; Pre-infusion & 30 minutes at end of obinutuzumab infusion on Day 1 of Cycle 4; 30 Days, 8 weeks after last infusion; 3, 6, 12, 18 & 24 months follow-up (approximately up to 32 months, Cycle length= 21 Days)
  • Incidence of antibody formation to study drug [ Time Frame: Up to approximately 1 year ]
  • Duration of objective response according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ]
  • Progression-free survival (PFS) according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 1 year ]
  • Pharmacokinetics: Maximum plasma and serum concentration (Cmax) [ Time Frame: Up to approximately 1 year ]
  • Pharmacokinetics: Clearance (CL) [ Time Frame: Up to approximately 1 year ]
  • Pharmacokinetics: Terminal half-life (t1/2) [ Time Frame: Up to approximately 1 year ]
  • Pharmacokinetics: Steady state volume of distribution (Vss) [ Time Frame: Up to approximately 1 year ]
Not Provided
Not Provided
 
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as a combination of polatuzumab vedotin with obinutuzumab in participants with relapsed or refractory follicular non-Hodgkin's lymphoma (NHL) and relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
  • Drug: Obinutuzumab
    Obinutuzumab 1000 mg will be administered by IV infusion on Day 1, 8, 15 of first 21-Day cycle and Day 1 of subsequent 21-day cycles for up to 8 cycles.
    Other Name: GA101, Gazyva, Gazyvaro
  • Drug: Pinatuzumab Vedotin
    Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycles.
    Other Name: DCDT2980S
  • Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycles.
    Other Name: DCDS4501A
  • Drug: Rituximab
    RTX 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycles.
    Other Name: MabThera/Rituxan
  • Experimental: RTX+Pinatuzumab Vedotin,Then RTX +Polatuzumab Vedotin (Arm A)
    For the first 2 cycles, RTX 375 milligrams per square meter (mg/m^2) will be given by intravenous (IV) infusion on Day 1 and pinatuzumab vedotin 2.4 milligrams per kilogram (mg/kg) will be administered by IV infusion on Day 2 to Arm A participants (with relapsed or refractory FL [r/r FL] and DLBCL). In the absence of any infusion-related adverse events, RTX and pinatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop disease progression would be further treated with RTX 375 mg/m^2 followed by polatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second disease progression event relative to the tumor assessment, documenting progressive disease on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).
    Interventions:
    • Drug: Pinatuzumab Vedotin
    • Drug: Polatuzumab Vedotin
    • Drug: Rituximab
  • Experimental: RTX+Polatuzumab Vedotin,Then RTX+Pinatuzumab Vedotin(Arm B)
    For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 2.4 mg/kg will be administered by IV infusion on Day 2 to Arm B participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop disease progression would be further treated with RTX 375 mg/m^2 followed by pinatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second disease progression event relative to the tumor assessment, documenting progressive disease on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).
    Interventions:
    • Drug: Pinatuzumab Vedotin
    • Drug: Polatuzumab Vedotin
    • Drug: Rituximab
  • Experimental: RTX + Polatuzumab Vedotin (Cohort C)
    For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 1.8 mg/kg will be administered by IV infusion on Day 2 to Cohort C participants (with r/r FL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Interventions:
    • Drug: Polatuzumab Vedotin
    • Drug: Rituximab
  • Experimental: RTX + Pinatuzumab Vedotin (Cohort D)
    For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and pinatuzumab vedotin 1.8 mg/kg will be administered by IV infusion on Day 2 to Cohort D participants (with r/r FL). In the absence of any infusion-related adverse events, RTX and pinatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Interventions:
    • Drug: Pinatuzumab Vedotin
    • Drug: Rituximab
  • Experimental: Obinutuzumab + Polatuzumab Vedotin (Cohort E)
    For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 1.8 mg/kg will be administered by IV infusion on Day 2 to Cohort C participants (with DLBCL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Interventions:
    • Drug: Obinutuzumab
    • Drug: Polatuzumab Vedotin
  • Experimental: Obinutuzumab + Polatuzumab Vedotin (Cohort G)
    For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort G participants (r/r follicular NHL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort G participants up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Interventions:
    • Drug: Obinutuzumab
    • Drug: Polatuzumab Vedotin
  • Experimental: Obinutuzumab + Polatuzumab Vedotin (Cohort H)
    For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort H participants (r/r DLBCL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort H participants up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Interventions:
    • Drug: Obinutuzumab
    • Drug: Polatuzumab Vedotin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
246
February 14, 2019
March 28, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • History of histologically documented relapsed or refractory Grades 1 to 3a follicular lymphoma (FL), or relapsed or refractory DLBCL
  • Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
  • Have a clinical indication for treatment as determined by the investigator
  • Must have at least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension by CT scan or magnetic resonance imaging [MRI])

Exclusion Criteria:

  • Prior use of any monoclonal antibody, radioimmuno-conjugate or antibody drug conjugate within 4 weeks before study start
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
  • Adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to grade less than equal to (<=) 2 prior study start
  • Completion of autologous stem cell transplant (SCT) within 100 days prior study start
  • Prior allogeneic SCT
  • Eligibility for autologous SCT (participants with relapsed or refractory DLBCL)
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Current or past history of central nervous system lymphoma
  • Current Grade >1 peripheral neuropathy
  • Vaccination with a live vaccine within 28 days prior to treatment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Italy,   Netherlands,   United States
 
 
NCT01691898
GO27834
2011-004377-84 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP