Trial record 1 of 1 for:    NCT01691898
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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 March 2015 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01691898
First received: September 16, 2012
Last updated: March 19, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Lymphoma, B-Cell, Lymphoma, Follicular
Drug: DCDS4501A
Drug: DCDT2980S
Drug: obinutuzumab
Drug: rituximab [MabThera/Rituxan]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 226
Study Start Date: September 2012
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCDS4501A in combination with MabThera/Rituxan Drug: DCDS4501A
Repeating intravenous dose
Other Name: polatuzumab vedotin
Drug: rituximab [MabThera/Rituxan]
Repeating intravenous dose
Experimental: DCDS4501A in combination with obinutuzumab Drug: DCDS4501A
Repeating intravenous dose
Other Name: polatuzumab vedotin
Drug: obinutuzumab
Repeating intravenous dose
Other Name: GA101, Gazyva, Gazyvaro
Experimental: DCDT2980S in combination with MabThera/Rituxan Drug: DCDT2980S
Repeating intravenous dose
Other Name: pinatuzumab vedotin
Drug: rituximab [MabThera/Rituxan]
Repeating intravenous dose

  Eligibility

Ages Eligible for Study:   18 Years and older
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 1-3a 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
  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. Only) global.rochegenentechtrials@roche.com

  Show 39 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

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: March 19, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Follicular
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Obinutuzumab
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 25, 2015