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
Ann Arbor, Michigan 48109
Click here to add this to my saved trials
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Click here to add this to my saved trials
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2200 East 3rd Street
Chattanooga, Tennessee 37404
Chattanooga, Tennessee 37404
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
15681 New Hampshire Court
Fort Myers, Florida 33901
Fort Myers, Florida 33901
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
601 South Floyd Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Click here to add this to my saved trials
Click here to add this to my saved trials
1 Medical Center Dr # 1000
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
Click here to add this to my saved trials
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
825 Eastlake Avenue East
Seattle, Washington 98101
Seattle, Washington 98101
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials