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
Completed · Phase 1
Conditions studied: Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT01290549
- Run by
- Genentech, Inc.
- People needed
- 95
- Starts
- 2011-03-22
- Expected to finish
- 2014-11-18
- Last updated by the study team
- 2017-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford Cancer Center — Stanford, California, United States
- Stanford Cancer Institute Pharmacy — Stanford, California, United States
- Florida Cancer Specialists; Sarasota — Sarasota, Florida, United States
- Roswell Park Cancer Inst. — Buffalo, New York, United States
- Sarah Cannon Cancer Center — Germantown, Tennessee, United States
- M.D Anderson Cancer Center; Oncology — Houston, Texas, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- Cross Cancer Institute ; Dept of Medical Oncology — Edmonton, Alberta, Canada
- British Columbia Cancer Agency — Vancouver, British Columbia, Canada
- McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology — Montreal, Quebec, Canada
- CHU Dijon - SCE Hemato — Dijon, France
- Centre Hospitalier Regional Universitaire de Lille — Lille, France
- CHU Lapeyronie, Hematologie — Montpellier, France
- Centre Hospitalier Lyon Sud; Hematolgie — Pierre-Bénite, France
- Centre Henri Becquerel; Hematologie — Rouen, France
- Academisch Medisch Centrum; Hematologie — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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