Clinical Trial Detail

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 in patients with relapsed or refractory follicular non-Hodgkin's lymphoma and relapsed/refractory diffuse large B-cell lymphoma.

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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)

Other eligibility criteria may apply.

- 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

Other exclusion criteria may apply.