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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01691898
First received: September 16, 2012
Last updated: September 1, 2016
Last verified: September 2016

September 16, 2012
September 1, 2016
September 2012
January 2019   (final data collection date for primary outcome measure)
  • Duration of Objective Response [ Time Frame: Screening up to 8 weeks after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Number of Participants With Complete Response (CR) Based on Positron Emission Tomographic (PET) Assessment [ Time Frame: Polatuzumab Vedotin + Obinutuzumab: Screening up to 8 weeks after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: maximum up to 3 years ] [ Designated as safety issue: No ]
  • Number of Participants With Objective Response [ Time Frame: Screening up to 8 weeks after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Objective response according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01691898 on ClinicalTrials.gov Archive Site
  • Systemic Clearance (CL) [ Time Frame: 0 minute (before study drug infusion), 30 minutes (after study drug infusion), at 3 and 9 week infusions (before and 30 minutes after study drug infusion), and 1, 2, 4, 6, 12, 18 and 24 months after treatment completion (maximum up to 3 years) ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0 minute (before study drug infusion), 30 minutes (after study drug infusion), at 3 and 9 week infusions (before and 30 minutes after study drug infusion), and 1, 2, 4, 6, 12, 18 and 24 months after treatment completion (maximum up to 3 years) ] [ Designated as safety issue: No ]
  • Volume of Distribution at Steady State (Vss) [ Time Frame: 0 minute (before study drug infusion), 30 minutes (after study drug infusion), at 3 and 9 week infusions (before and 30 minutes after study drug infusion), and 1, 2, 4, 6, 12, 18 and 24 months after treatment completion (maximum up to 3 years) ] [ Designated as safety issue: No ]
  • Number of Participants With Anti-Drug Antibody [ Time Frame: 0 minute (before first study drug infusion), 0 minute on day of infusion at 3 and 9 weeks; 15 to 30 days after last treatment, and at 6 to 8 weeks and 3, 6, 12, 18 and 24 months after last treatment (maximum up to 3 years) ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) [ Time Frame: Baseline, at 14 to 16 weeks after first dose, and 6 to 8 weeks after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Baseline up to last dose of study drug and every 3 months after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Number of Participants With Complete Response (CR) Based on Computed Tomography (CT) Assessment [ Time Frame: Polatuzumab Vedotin + Obinutuzumab: Baseline, at 14 to 16 weeks after first dose, and 6 to 8 weeks after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Number of Participants With Objective Response (CR+PR) Based on PET and CT Assessments [ Time Frame: Polatuzumab Vedotin + Obinutuzumab: Baseline, at 14 to 16 weeks after first dose, and 6 to 8 weeks after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Number of Participants With Best Overall Response Based on PET and CT Assessments [ Time Frame: Polatuzumab Vedotin + Obinutuzumab: Baseline, at 14 to 16 weeks after first dose, and 6 to 8 weeks after last dose of study drug (maximum up to 2 years) ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 0 minute (before study drug infusion), 30 minutes (after study drug infusion), at 3 and 9 week infusions (before and 30 minutes after study drug infusion), and 1, 2, 4, 6, 12, 18 and 24 months after treatment completion (maximum up to 3 years) ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 minute (before study drug infusion), 30 minutes (after study drug infusion), at 3 and 9 week infusions (before and 30 minutes after study drug infusion), and 1, 2, 4, 6, 12, 18 and 24 months after treatment completion (maximum up to 3 years) ] [ Designated as safety issue: No ]
  • Incidence of antibody formation to study drug [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Duration of objective response according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum plasma and serum concentration (Cmax) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Clearance (CL) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Terminal half-life (t1/2) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Steady state volume of distribution (Vss) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety and Efficacy Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab (MabThera/Rituxan) or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab and Polatuzumab Vedotin Combined With Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (ROMULUS)
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 the efficacy of Pinatuzumab Vedotin (DCDT2980S) in combination with rituximab (MabThera/Rituxan) or Polatuzumab Vedotin (DCDS4501A) in combination with rituximab, as well as a combination of Polatuzumab Vedotin with obinutuzumab in participants with relapsed or refractory follicular non-Hodgkin's lymphoma and relapsed/refractory diffuse large B-cell lymphoma.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-Cell Lymphoma, Lymphoma, Follicular
  • Drug: Obinutuzumab
    Obinutuzumab 1000 mg intravenous infusion administered 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 milligram per kilogram body weight (mg/kg) intravenous infusion administered on Day 1 of 21-day cycles for 6 months or 1 year.
    Other Name: DCDT2980S
  • Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 milligram per kilogram body weight (mg/kg) intravenous infusion administered on Day 1 of 21-day cycles for up to 6-8 cycles or 1 year.
    Other Name: DCDS4501A
  • Drug: Rituximab
    Rituximab 375 milligram per square meter (mg/m^2) intravenous infusion administered on Day 1 of 21-day cycles for 1 year.
    Other Name: MabThera/Rituxan
  • Experimental: Pinatuzumab Vedotin + Rituximab
    Interventions:
    • Drug: Obinutuzumab
    • Drug: Pinatuzumab Vedotin
    • Drug: Rituximab
  • Experimental: Polatuzumab Vedotin + Obinutuzumab
    Interventions:
    • Drug: Obinutuzumab
    • Drug: Polatuzumab Vedotin
  • Experimental: Polatuzumab Vedotin + Rituximab
    Interventions:
    • Drug: Pinatuzumab Vedotin
    • Drug: Polatuzumab Vedotin
    • Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
246
January 2019
January 2019   (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, or relapsed or refractory diffuse large B-cell lymphoma (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 computed tomography [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
Both
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: GO27834 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com
United States,   Canada,   France,   Germany,   Italy,   Netherlands
 
NCT01691898
GO27834, 2011-004377-84
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
September 2016

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