Trial record 1 of 1 for:    NCT01691898
Previous Study | Return to List | Next Study

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 August 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01691898
First received: September 16, 2012
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 246
Study Start Date: September 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pinatuzumab Vedotin + Rituximab 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: 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: Polatuzumab Vedotin + Obinutuzumab 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: 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
Experimental: Polatuzumab Vedotin + Rituximab 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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, 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691898

Contacts
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

  Show 41 Study Locations
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 
Study First Received: September 16, 2012
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
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

ClinicalTrials.gov processed this record on August 25, 2016