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A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
Not Recruiting
Trial ID: NCT01290549
Purpose
This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin
administered as a single agent by intravenous (IV) infusion to participants with relapsed or
refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab
vedotin in combination with rituximab.
Official Title
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics Of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
Eligibility
Inclusion Criteria:
- Life expectancy of at least 12 weeks
- History of one of the following histologically-documented hematologic malignancy for
which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL),
Grade 3b follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell
lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
- All participants (NHL and B-cell chronic lymphocytic leukemia [B-CLL]) must have at
least one bi-dimensionally measurable lesion
- For all men or women of childbearing potential (unless surgically sterile): use of
adequate methods of contraception such as oral contraceptives, intrauterine device, or
barrier method of contraception in conjunction with spermicidal jelly
Exclusion Criteria:
- Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before
Cycle 1, Day 1
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other
investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse
events from any previous treatments must be resolved or stabilized prior to Cycle 1,
Day 1, except for neuropathy
- Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
- Prior allogeneic stem cell transplant
Intervention(s):
drug: rituximab
drug: Polatuzumab Vedotin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061