A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Lymphoma, Non Hodgkin

In brief

This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.

Key facts

Study ID: NCT01992653
Run by: Genentech, Inc.
People needed: 85
Starts: 2013-11-29
Expected to finish: 2018-12-19
Last updated by the study team: 2023-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All Participants:
At least one bi-dimensionally measurable lesion, defined as greater than (>) 1.5 centimeters (cm) in its longest dimension
Life expectancy of at least 24 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Adequate hematologic function (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator)
Agreement to use highly effective contraception measures. Women of childbearing potential must agree to remain abstinent or use contraceptive measures that result in a failure rate of <1 percent (%) per year during the treatment period and for at least 12 months for R-CHP arm or for at least 18 months for G-CHP arm after the last dose of study drug. Men must agree to remain abstinent or to use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of study drug
Dose-Escalation Portion of the Study:
Histologically confirmed B-cell NHL: Participants with newly diagnosed B-cell NHL or relapsed/refractory B-cell NHL are eligible
No more than one prior systemic treatment regimen for B-cell NHL (single agent anti-cluster of differentiation [CD] 20 monoclonal antibody therapy will not be counted as a prior treatment regimen)
No prior treatment with anthracyclines
Expansion Portion of the Study:
Previously untreated participants with diffuse large B-cell lymphoma (DLBCL)
International Prognostic Index (IPI) score of 2-5

You may not qualify if…

Dose-Escalation Portion of the Study:
Diagnosis of primary mediastinal DLBCL
Expansion Portion of the Study:
Participants with transformed lymphoma
Prior therapy for NHL
All Participants:
Prior stem cell transplant
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to receive any of the individual components of R-CHP or G-CHP
Current Grade greater than (>) 1 peripheral neuropathy
Ongoing corticosteroid use of >30 milligrams per day (mg/day) of prednisone/prednisolone or equivalent. Participants receiving corticosteroid treatment with less than or equal to (</=) 30 mg/day of prednisone/prednisolone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration before Cycle 1 Day 1
Primary central nervous system (CNS) lymphoma
Vaccination with live vaccines within 6 months before Cycle 1 Day 1
History of other malignancy that could affect compliance with the protocol or interpretation of results. Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Participants with a malignancy that has been treated with surgery alone with curative intent will also be excluded unless the malignancy has been in documented remission without treatment for greater than or equal to (</=) 5 years before enrollment
Evidence of significant, uncontrolled concomitant diseases, including renal disease that would preclude chemotherapy administration, or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before Cycle 1 Day 1
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Positive for hepatitis B or hepatitis C infection
Prior radiotherapy to the mediastinal/pericardial region
Pregnant or lactating women
Recent major surgery within 6 weeks before the start of Cycle 1 Day 1

Where it is running

The University of Alabama at Birmingham — Birmingham, Alabama, United States
Banner MD Anderson Cancer Center — Greeley, Colorado, United States
Washington University; Pediatrics — St Louis, Missouri, United States
Northwest Cancer Specialists — Portland, Oregon, United States
Oregon Health and Science University — Portland, Oregon, United States
Willamette Valley Clinical Studies; Cancer Institute — Springfield, Oregon, United States
Blue Ridge Cancer Care — Roanoke, Virginia, United States
Hopital Henri Mondor, Unite Hemopathies lymphoides — Créteil, France
Hopital Claude Huriez - CHU Lille; Service des maladies du sang — Lille, France
Centre Hospitalier Lyon Sud; Hematolgie — Pierre-Bénite, France
Centre Henri Becquerel; Hematologie — Rouen, France

Full record on ClinicalTrials.gov

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