A Study of DCDT2980S in Combination With MabThera/Rituxan or DCDS4501A in Combination With MabThera/Rituxan and Evaluation of Combination DCDS4501A and Obinutuzumab in Patients With Non-Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01691898
First received: September 16, 2012
Last updated: April 1, 2015
Last verified: April 2015

September 16, 2012
April 1, 2015
September 2012
November 2019   (final data collection date for primary outcome measure)
  • Safety: Incidence of adverse events [ Time Frame: Up to approximately 6 months ] [ Designated as safety issue: No ]
  • Objective response according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year; up to 2 years for obinutuzumab-containing cohorts ] [ 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
  • Incidence of antibody formation to study drug [ Time Frame: Up to approximately 1 year; up to 18 months for obinutuzumab-containing cohorts ] [ 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; up to 2 years for obinutuzumab-containing cohorts ] [ 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; up to 2 years for obinutuzumab-containing cohorts ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 1 year; up to 18 months for obinutuzumab-containing cohorts ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum plasma and serum concentration (Cmax) [ Time Frame: Up to approximately 1 year; up to 18 months for obinutuzumab-containing cohorts ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Clearance (CL) [ Time Frame: Up to approximately 1 year; up to 18 months for obinutuzumab-containing cohorts ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Terminal half-life (t1/2) [ Time Frame: Up to approximately 1 year; up to 18 months for obinutuzumab-containing cohorts ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Steady state volume of distribution (Vss) [ Time Frame: Up to approximately 1 year; up to 18 months for obinutuzumab-containing cohorts ] [ 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 Study of DCDT2980S in Combination With MabThera/Rituxan or DCDS4501A in Combination With MabThera/Rituxan and Evaluation of Combination DCDS4501A and Obinutuzumab in Patients With 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 randomized, multicenter, open-label study will evaluate the safety and the efficacy of DCDT2980S in combination with MabThera/Rituxan (rituximab) or DCDS4501A in combination with MabThera/Rituxan, as well as a combination of DCDS4501A with obinutuzumab in patients with relapsed or refractory follicular non-Hodgkin's lymphoma and relapsed/refractory diffuse large B-cell lymphoma.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, B-Cell, Lymphoma, Follicular
  • Drug: DCDS4501A
    Repeating intravenous dose
    Other Name: polatuzumab vedotin
  • Drug: DCDT2980S
    Repeating intravenous dose
    Other Name: pinatuzumab vedotin
  • Drug: obinutuzumab
    Repeating intravenous dose
    Other Name: GA101, Gazyva, Gazyvaro
  • Drug: rituximab [MabThera/Rituxan]
    Repeating intravenous dose
  • Experimental: DCDS4501A in combination with MabThera/Rituxan
    Interventions:
    • Drug: DCDS4501A
    • Drug: rituximab [MabThera/Rituxan]
  • Experimental: DCDS4501A in combination with obinutuzumab
    Interventions:
    • Drug: DCDS4501A
    • Drug: obinutuzumab
  • Experimental: DCDT2980S in combination with MabThera/Rituxan
    Interventions:
    • Drug: DCDT2980S
    • Drug: rituximab [MabThera/Rituxan]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
226
November 2019
November 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 1-3a follicular lymphoma, or relapsed or refractory diffuse large B-cell lymphoma
  • 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 (>1.5 cm in its largest dimension by CT scan or 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 </=2 prior study start
  • Completion of autologous stem cell transplant within 100 days prior study start
  • Prior allogeneic stem cell transplant
  • Eligibility for autologous SCT (patients 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 CNS lymphoma
  • Current Grade > 1 peripheral neuropathy
Both
18 Years and older
No
Contact: Reference Study ID Number: GO27834 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Canada,   France,   Germany,   Italy,   Netherlands
 
NCT01691898
GO27834, 2011-004377-84
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
April 2015

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