JHL-CLIN-1101-03
Research type
Research Study
Full title
A Multinational, Randomized, Double-blind, Positive-controlled, Parallel Group Clinical Study to Compare the Efficacy and Safety of the JHL1101 in Combination with CHOP (J-CHOP) versus Rituximab in Combination with CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
IRAS ID
252134
Contact name
Paul Kerr
Contact email
Sponsor organisation
JHL Biotech (Hong Kong) Limited
Eudract number
2018-002342-36
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The purpose of this study is to see if the study drug 'JHL1101' works in the same way as an existing treatment (MabThera) for patients with a type of blood cancer called Large B-cell Lymphoma, who have not been treated for it before. Both JHL1101 and MabThera will be used in combination with some other drugs (cyclophosphamide,
doxorubicin, vincristine, and prednisone). This is called the CHOP regimen.
Diffuse Large B-cell Lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL). DLBCL is an aggressive (fast-growing) NHL that affects B-cells, which are lymphocytes (cells of the immune system) that make antibodies to fight infections. All lymphomas, including DLBCL, affect the organs of the lymphatic system. The lymphatic system is what allows the body to fight infections.
JHL1101 is a biosimilar, which means that it is very similar, to an existing (approved) biological therapy MabThera® (rituximab). A “biological therapy” involves a medical product which contains one or more substances which are to some degree identical to those naturally occurring in humans.
Approximately 500 participants will be included in the study. Participants will be screened against the study Protocol inclusion and exclusion criteria to check they are eligible to join the study.
The study has three periods: Screening Period (an evaluation before the start of treatment to check eligibility for the study), Treatment Period (when participants will receive JHL1101 in combination with CHOP regimen or MabThera® in combination with CHOP), and a Follow-up Period. A total of 6 treatment cycles (each cycle consists of 3 weeks) are planned throughout the study.REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0267
Date of REC Opinion
23 Jan 2019
REC opinion
Further Information Favourable Opinion