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Trial record 1 of 1 for:    NCT01691898
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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:
ClinicalTrials.gov Identifier:
NCT01691898
First Posted: September 25, 2012
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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).

Condition Intervention Phase
Follicular Lymphoma, Diffuse Large B-Cell Lymphoma Drug: Obinutuzumab Drug: Pinatuzumab Vedotin Drug: Polatuzumab Vedotin Drug: Rituximab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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)


Enrollment: 246
Actual Study Start Date: September 26, 2012
Estimated Study Completion Date: February 14, 2019
Primary Completion Date: March 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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+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).
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 + 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.
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 (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.
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: Rituximab
RTX 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycles.
Other Name: MabThera/Rituxan
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.
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: 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
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.
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: 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
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.
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: 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691898


  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford Cancer Center
Stanford, California, United States, 94305-5820
United States, Colorado
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University Medical Center Lombardi Cancer Center
Washington, D.C., District of Columbia, United States, 20057
United States, Florida
Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
Fort Myers, Florida, United States, 33905
Florida Cancer Specialists; Sarasota
Sarasota, Florida, United States, 34232
United States, Michigan
Univ of Michigan Med School; Hematology Oncology
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Hematology Oncology Associates; Carol G. Simon Ctr
Morristown, New Jersey, United States, 07960
Regional Cancer Care Associates LLC - Morristown
Morristown, New Jersey, United States, 07962
United States, New York
Roswell Park Cancer Inst.
Buffalo, New York, United States, 14263
New York University Cancer Cen
New York, New York, United States, 10016
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
United States, Oregon
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, United States, 97401-8122
Oregon Health Sciences Uni
Portland, Oregon, United States, 97239
United States, Tennessee
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Transplant Inst.
San Antonio, Texas, United States, 78229
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Fairfax N Virginia Hem/Onc PC
Fairfax, Virginia, United States, 22031
Oncology & Hematolgy Associates of SW Va Inc. - Roanoke
Roanoke, Virginia, United States, 24014
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States, 98684
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
United States, Wisconsin
Univ of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 1H6
Canada, Quebec
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
France
Hopital Claude Huriez - CHU Lille
Lille, France, 59037
CHU Montpellier - Saint ELOI
Montpellier, France, 34295
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
Paris, France, 75475
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Henri Becquerel; Hematologie
Rouen, France, 76038
Germany
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, Germany, 69120
Universitätsmedizin Johannes Gutenberg Universität; Klinik u. Poliklinik f. Neurologie
Mainz, Germany, 55131
Klinikum d.Universität München Campus Großhadern
München, Germany, 81377
Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy, 40138
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
Azienda Ospedale San Giovanni
Torino, Piemonte, Italy, 10126
Netherlands
Academisch Medisch Centrum; Hematologie
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01691898     History of Changes
Other Study ID Numbers: GO27834
2011-004377-84 ( EudraCT Number )
First Submitted: September 16, 2012
First Posted: September 25, 2012
Last Update Posted: August 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Obinutuzumab
Rituximab
Antibodies, Monoclonal
Immunoconjugates
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents