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

Part of paid clinical trials in Stanford, California.

Sponsor
Genentech, Inc.
Study ID
NCT01290549
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Participants will receive escalating intravenous dose of polatuzumab vedotin.
  • Rituximab — DRUG
    Rituximab will be administered by an IV infusion at 375 mg/m\^2 body surface area dose q3w.

Study Details

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 Dates

Start date
Mar 22, 2011
Status verified
Jun 2017
Primary completion
Jun 29, 2012
Completion
Nov 18, 2014

Study Design

Enrollment
95 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Polatuzumab Vedotin
    Polatuzumab vedotin will be administered by an IV infusion of escalating doses (starting dose of 0.1 mg/kg, potentially to be followed by 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, and 4.0 mg/kg doses) every 3 weeks (q3w) (Day 1 of each 21 day cycle).
  • Experimental: Polatuzumab Vedotin + Rituximab
    Polatuzumab vedotin will be administered by an IV infusion q3w (Day 1 of each 21 day cycle). Rituximab was administered by an IV infusion at 375 milligrams per square meter (mg/m\^2) body surface area dose q3w.

Primary Outcome Measure

Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Days 1-21) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterStanfordCalifornia94305-5820-
Stanford Cancer Institute PharmacyStanfordCalifornia94305-
Florida Cancer Specialists; SarasotaSarasotaFlorida34232-
Roswell Park Cancer Inst.BuffaloNew York14263-
Sarah Cannon Cancer CenterGermantownTennessee38138-
M.D Anderson Cancer Center; OncologyHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

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