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

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