A Study of DCDT2980S and DCDS4501A Combined with Rituximab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma.
- Conditions
- Follicular Non-Hodgkin's Lymphoma (FL)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864Diffuse Large B-CellLymphoma (DLBCL)
- Registration Number
- EUCTR2011-004377-84-NL
- Lead Sponsor
- Genentech Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
- Life expectancy of at least 12 weeks;
- Age = 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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 80
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Safety and tolerability and anti-tumor activity of DCDT2908S combined<br>with Rituximab and DCDS4501A combined with Rituximab.;Secondary Objective: Incidence of anti-therapeutic antibodies (ATA) against DCDT2980S and<br>DCDS4501A; assessment of quality of life as measured by patient<br>reported outcomes.;Primary end point(s): - Incidence of adverse events;<br>- Nature of adverse events;<br>- Severity of adverse events;<br>- Objective response rate;<br>- Duration of response.;Timepoint(s) of evaluation of this end point: Up to 12 months.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Incidence of anti-therapeutic antibodies (ATAs) against DCDT2980S and DCDS4501A.;Timepoint(s) of evaluation of this end point: Up to 12 months.