NCT01290549

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Typical duration for phase_1

Geographic Reach
4 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2012

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2014

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

February 3, 2011

Last Update Submit

June 14, 2017

Conditions

Non-Hodgkins LymphomaChronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (4)

  • Percentage of Participants With Dose-Limiting Toxicities (DLTs)

    Cycle 1 (Days 1-21)

  • Maximum Tolerated Dose

    Cycle 1 (Days 1-21)

  • Proposed Phase II Dose of Polatuzumab Vedotin

    Cycle 1 (Days 1-21)

  • Percentage of Participants With Adverse Events (AEs)

    Baseline up to 646 Days

Secondary Outcomes (23)

  • Percentage of Paticipants with Anti Therapeutic Antibodies (ATAs) Against Polatuzumab Vedotin

    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)

    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

    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

    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

    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])

  • +18 more secondary outcomes

Study Arms (2)

Polatuzumab Vedotin

EXPERIMENTAL

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

Polatuzumab Vedotin + Rituximab

EXPERIMENTAL

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 VedotinDrug: Rituximab

Interventions

Polatuzumab VedotinDRUG

Participants will receive escalating intravenous dose of polatuzumab vedotin.

Also known as: DCDS4501A
Polatuzumab VedotinPolatuzumab Vedotin + Rituximab
RituximabDRUG

Rituximab will be administered by an IV infusion at 375 mg/m\^2 body surface area dose q3w.

Polatuzumab Vedotin + Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Stanford Cancer Center

Stanford, California, 94305-5820, United States

Location

Stanford Cancer Institute Pharmacy

Stanford, California, 94305, United States

Location

Florida Cancer Specialists; Sarasota

Sarasota, Florida, 34232, United States

Location

Roswell Park Cancer Inst.

Buffalo, New York, 14263, United States

Location

Sarah Cannon Cancer Center

Germantown, Tennessee, 38138, United States

Location

M.D Anderson Cancer Center; Oncology

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 1H6, Canada

Location

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec, H3T 1E2, Canada

Location

CHU Dijon - SCE Hemato

Dijon, 21000, France

Location

Centre Hospitalier Regional Universitaire de Lille

Lille, France

Location

CHU Lapeyronie, Hematologie

Montpellier, 34295, France

Location

Centre Hospitalier Lyon Sud; Hematolgie

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel; Hematologie

Rouen, 76038, France

Location

Academisch Medisch Centrum; Hematologie

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (3)

  • Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

    PMID: 32770353DERIVED

  • Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

    PMID: 32705923DERIVED

  • Palanca-Wessels MC, Czuczman M, Salles G, Assouline S, Sehn LH, Flinn I, Patel MR, Sangha R, Hagenbeek A, Advani R, Tilly H, Casasnovas O, Press OW, Yalamanchili S, Kahn R, Dere RC, Lu D, Jones S, Jones C, Chu YW, Morschhauser F. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol. 2015 Jun;16(6):704-15. doi: 10.1016/S1470-2045(15)70128-2. Epub 2015 Apr 27.

    PMID: 25925619DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

polatuzumab vedotinRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Yu-Waye Chu, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 7, 2011

Study Start

March 22, 2011

Primary Completion

June 29, 2012

Study Completion

November 18, 2014

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

US(7)CA(3)NL(1)FR(5)