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Complete title: 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
|Research Study Number||2649.00|
|Principal Investigator||Oliver Press, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
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.
Exclusions (conditions that would prevent participation in this study)
- 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.
Lymphoma; Lymphoproliferative Disease; Non-Hodgkin's Lymphoma (NHL)
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