NL-OMON39673
Completed
Phase 2
A randomized, open-label, multicenter, phase II trial evaluating the safety and activity of DCDT2980S in combination with rituximab or DCDS4501A in combination with rituximab in patients with relapsed or refractory B-cell non Hodgkin's lymphoma. - Genentech GO27834 study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non Hodgkin's Lymphoma
- Sponsor
- Genentech Inc
- Enrollment
- 3
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent Form(s)
- •Age \>\= 18 years
- •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 FL,
- •or relapsed or refractory 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
Exclusion Criteria
- •Prior use of any monoclonal antibody, radioimmunoconjugate or antibodydrug
- •conjugate within 4 weeks before Cycle 1, Day 1
- •Treatment with radiotherapy, chemotherapy, immunotherapy,
- •immunosuppressive therapy, or any investigational anti\-cancer agent within
- •2 weeks prior to Cycle 1, Day 1
- •Adverse events except for sensory neuropathy from any previous
- •treatments must be resolved or stabilized to Grade \<\= 2 prior to Cycle 1,
- •Completion of autologous stem cell transplant within 100 days prior to
- •Cycle 1, Day 1
- •Prior allogeneic stem cell transplant
Outcomes
Primary Outcomes
Not specified
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