A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Not Recruiting

Trial ID: NCT01691898

Purpose

This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).

Official Title

A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Eligibility


Inclusion Criteria:

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

   - Life expectancy of at least 12 weeks

   - History of histologically documented r/r Grades 1 to 3a FL, or r/r 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

   - Must have at least one bi-dimensionally measurable lesion (greater than [>] 1.5
   centimeters [cm] in its largest dimension by CT scan or Magnetic Resonance Imaging
   [MRI])

Exclusion Criteria:

   - Prior use of any monoclonal antibody, radio-immuno-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 less than equal to (
   - Completion of autologous stem cell transplant (SCT) within 100 days prior study start

   - Prior allogeneic SCT

   - Eligibility for autologous SCT (participants with r/r 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 central nervous system lymphoma

   - Current Grade >1 peripheral neuropathy

   - Vaccination with a live vaccine within 28 days prior to treatment

Intervention(s):

drug: Pinatuzumab Vedotin

drug: Polatuzumab Vedotin

drug: Rituximab

drug: obinutuzumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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