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Trial record 1 of 1 for:    NCT01290549
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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01290549
First Posted: February 7, 2011
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  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.

Condition Intervention Phase
Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia Drug: Polatuzumab Vedotin Drug: Rituximab Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Days 1-21) ]
  • Maximum Tolerated Dose [ Time Frame: Cycle 1 (Days 1-21) ]
  • Proposed Phase II Dose of Polatuzumab Vedotin [ Time Frame: Cycle 1 (Days 1-21) ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 646 Days ]

Secondary Outcome Measures:
  • Percentage of Paticipants with Anti Therapeutic Antibodies (ATAs) Against Polatuzumab Vedotin [ Time Frame: Preinfusion (0 hour) on Day 1 of Cycles 1, 2, 4, and at the treatment completion/early termination visit (up to 646 days) ]
  • Progression Free Survival (PFS), as Assessed by Using Modified Response Criteria for Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) [ Time Frame: Baseline up to disease progression or death (Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug [up to 44.5 months]) ]
  • Percentage of Participants With Objective Response [Complete Response (CR) or Partial Response (PR)], as Assessed by Using Modified Response Criteria for NHL or CLL [ Time Frame: Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug (up to 44.5 months) ]
  • Duration of Response, as Assessed by Using Modified Response Criteria for NHL or CLL [ Time Frame: Baseline up to disease progression or death (Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug [up to 44.5 months]) ]
  • Percentage of Participants with Best Overall Response (BOR), as Assessed by Using Modified Response Criteria for NHL or CLL [ Time Frame: Baseline up to disease progression or death (Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug [up to 44.5 months]) ]
  • Area Under the Curve (AUC) from Time 0 to The Last Quantifiable Time Point (AUClast)-Polatuzumab Vedotin Monotherapy [ Time Frame: Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • AUC Extrapolating to Time of Infinity (AUCinf)-Polatuzumab Vedotin Monotherapy [ Time Frame: Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • Percentage of AUCinf (AUCextrap)-Polatuzumab Vedotin Monotherapy [ Time Frame: Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • Maximum Plasma Concentration (Cmax)-Polatuzumab Vedotin Monotherapy [ Time Frame: Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • Clearance-Polatuzumab Vedotin Monotherapy [ Time Frame: Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • Volume of Distribution at Steady State-Polatuzumab Vedotin Monotherapy [ Time Frame: Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • AUClast - Polatuzumab Vedotin Combined with Rituximab [ Time Frame: Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • AUCinf-Polatuzumab Vedotin Combined with Rituximab [ Time Frame: Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • AUCextrap-Polatuzumab Vedotin Combined with Rituximab [ Time Frame: Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • Cmax-Polatuzumab Vedotin Combined with Rituximab [ Time Frame: Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • Clearance-Polatuzumab Vedotin Combined with Rituximab [ Time Frame: Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • Volume of Distribution at Steady State-Polatuzumab Vedotin Combined with Rituximab [ Time Frame: Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) ]
  • AUClast of Rituximab When Given in Combination With Polatuzumab Vedotin [ Time Frame: Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) ]
  • AUCinf of Rituximab When Given in Combination With Polatuzumab Vedotin [ Time Frame: Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) ]
  • AUCextrap of Rituximab When Given in Combination With Polatuzumab Vedotin [ Time Frame: Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) ]
  • Cmax of Rituximab When Given in Combination With Polatuzumab Vedotin [ Time Frame: Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) ]
  • Clearance of Rituximab When Given in Combination With Polatuzumab Vedotin [ Time Frame: Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) ]
  • Volume of Distribution at Steady State-of Rituximab When Given in Combination With Polatuzumab Vedotin [ Time Frame: Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) ]

Enrollment: 95
Actual Study Start Date: March 22, 2011
Study Completion Date: November 18, 2014
Primary Completion Date: June 29, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Polatuzumab Vedotin
Participants will receive escalating intravenous dose of polatuzumab vedotin.
Other Name: DCDS4501A
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.
Drug: Polatuzumab Vedotin
Participants will receive escalating intravenous dose of polatuzumab vedotin.
Other Name: DCDS4501A
Drug: Rituximab
Rituximab will be administered by an IV infusion at 375 mg/m^2 body surface area dose q3w.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290549


Locations
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5820
Stanford Cancer Institute Pharmacy
Stanford, California, United States, 94305
United States, Florida
Florida Cancer Specialists; Sarasota
Sarasota, Florida, United States, 34232
United States, New York
Roswell Park Cancer Inst.
Buffalo, New York, United States, 14263
United States, Tennessee
Sarah Cannon Cancer Center
Germantown, Tennessee, United States, 38138
United States, Texas
M.D Anderson Cancer Center; Oncology
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Canada, Alberta
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 1H6
Canada, Quebec
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
France
CHU Dijon - SCE Hemato
Dijon, France, 21000
Centre Hospitalier Regional Universitaire de Lille
Lille, France
CHU Lapeyronie, Hematologie
Montpellier, France, 34295
Centre Hospitalier Lyon Sud; Hematolgie
Pierre Benite, France, 69495
Centre Henri Becquerel; Hematologie
Rouen, France, 76038
Netherlands
Academisch Medisch Centrum; Hematologie
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Yu-Waye Chu, M.D. Genentech, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01290549     History of Changes
Other Study ID Numbers: DCS4968g
GO01294 ( Other Identifier: Hoffmann-La Roche )
2011-002330-39 ( EudraCT Number )
First Submitted: February 3, 2011
First Posted: February 7, 2011
Last Update Posted: June 16, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Antibodies, Monoclonal
Immunoconjugates
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents