A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/23/2019 |
Start Date: | November 16, 2017 |
End Date: | April 15, 2023 |
Contact: | Reference Study ID Number: GO39942 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy,
safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants
with previously untreated diffuse large B-cell lymphoma (DLBCL).
safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants
with previously untreated diffuse large B-cell lymphoma (DLBCL).
Inclusion Criteria:
- Previously untreated participants with cluster of differentiation 20 (CD20)-positive
DLBCL, including one of the following diagnoses by 2016 World Health Organization
(WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS)
including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich
large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma
kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive
DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or
B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma);
High-grade B-cell lymphoma, NOS
- Availability of archival or freshly collected tumor tissue before study enrolment
- International Prognostic Index (IPI) score of 2-5
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy greater than or equal to (>/=)12 months
- Left ventricular ejection fraction (LVEF) >/= 50 percent (%) on cardiac multiple-gated
acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Adequate hematologic function
Exclusion Criteria:
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products
- Contraindication to any of the individual components of CHOP, including prior receipt
of anthracyclines
- Prior organ transplantation
- Current Grade greater than (>) 1 peripheral neuropathy by clinical examination
- Demyelinating form of Charcot-Marie-Tooth disease
- History of indolent lymphoma
- History of follicular lymphoma grade 3B
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and
classical Hodgkin lymphoma (grey-zone lymphoma)
- Primary mediastinal (thymic) large B-cell lymphoma
- Burkitt lymphoma
- Prior treatment with cytotoxic drugs within 5 years of screening for any condition
(example [e.g.], cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody
- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
- Prior therapy for DLBCL, with the exception of nodal biopsy
- Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than
lymphoma symptom control
- Participants with central nervous system (CNS) lymphoma (primary or secondary
involvement), primary effusion DLBCL, and primary cutaneous DLBCL
- Vaccination with live vaccines within 28 days prior to the start of Cycle 1
- Any investigational therapy within 28 days prior to the start of Cycle 1
- History of other malignancy that could affect compliance with the protocol or
interpretation of results
- Evidence of significant, uncontrolled, concomitant diseases that could affect
compliance with the protocol or interpretation of results, including significant
cardiovascular disease or pulmonary disease
- Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for
diagnosis
- History or presence of an abnormal electrocardiogram (ECG) that is clinically
significant in the investigator's opinion, including complete left bundle branch
block, second- or third-degree heart block, or evidence of prior myocardial infarction
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment or significant
infections within 2 weeks before the start of Cycle 1
- Clinically significant liver disease, including active viral or other hepatitis,
current alcohol abuse, or cirrhosis
- Prior radiotherapy to the mediastinal/pericardial region
- Participants with suspected active or latent tuberculosis
- Positive test results for chronic hepatitis B and hepatitis C infection
- Known history of human immunodeficiency virus (HIV) seropositive status
- Positive results for the human T-lymphotrophic 1 virus (HTLV-1)
- Participants with a history of progressive multifocal leukoencephalopathy
We found this trial at
55
sites
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Ann Arbor, Michigan 48109
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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2200 East 3rd Street
Chattanooga, Tennessee 37404
Chattanooga, Tennessee 37404
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650 Commack Rd
Commack, New York 11725
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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15681 New Hampshire Court
Fort Myers, Florida 33901
Fort Myers, Florida 33901
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601 South Floyd Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
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1 Medical Center Dr # 1000
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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825 Eastlake Avenue East
Seattle, Washington 98101
Seattle, Washington 98101
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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