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Clinical Trials/EUCTR2011-004377-84-DE
EUCTR2011-004377-84-DE
Active, not recruiting
Phase 1

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.

Genentech, Inc.0 sites230 target enrollmentOctober 2, 2012
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ConditionsFollicular Non-Hodgkin’s Lymphoma (FL)Diffuse Large B-Cell Lymphoma (DLBCL)MedDRA version: 20.1 Level: LLT Classification code 10012857 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10012855 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) System Organ Class: 100000004864MedDRA version: 20.1 Level: LLT Classification code 10012856 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsMabtheraGazyvaro

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Follicular Non-Hodgkin’s Lymphoma (FL)
Sponsor
Genentech, Inc.
Enrollment
230
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 2, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Life expectancy of at least 12 weeks;
  • •\- Age \> or \= 18 years;
  • •\- History of histologically documented relapsed or refractory Grades 1\-3a FL, or relapsed or refractory DLBCL;
  • •\- Must have at least one bi\-dimensionally measurable lesion;
  • •\- Adequate hepatic, renal and cardiopulmonary function;
  • •\- For all men and women of childbearing potential use of adequate methods of contraception.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 61

Exclusion Criteria

  • •\- Prior use of any monoclonal antibody, radioimmunoconjugate or antibody\-drug conjugate within 4 weeks before Cycle 1 Day1;
  • •\- Treatment with radiotherapy, chemotherapy, immunotherapy, or an investigational anti\-cancer agent within 2 weeks prior to Cycle 1 Day 1;
  • •\- Prior autologous stem cell transplant within 100 days prior to Cycle 1 Day 1;
  • •\- Prior allogeneic stem cell transplant;
  • •\- Eligibility for autologous stem cell transplant.

Outcomes

Primary Outcomes

Not specified

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