Bone Marrow Transplant
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.
- 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)
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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