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Brief Title: Biomarker Driven Intensified ChemoImmunotherapy With Early CNS Prophylaxis
Official Title: Biomarker Driven and Dose Intensified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk Diffuse Large B-Cell Lymphoma
Study ID: NCT03293173
Brief Summary: This study is testing whether stratification of the patients according to biological risk factors for different treatment groups will improve the outcome of patients with clinically high diffuse large B-cell lymphoma (DLBCL).
Detailed Description: For young clinically high-risk diffuse large B-cell lymphoma (DLBCL) patients the optimal therapy has not been established. Previous Nordic phase II studies, where dose-dense chemoimmunotherapy (R-CHOEP-14) with systemic CNS prophylaxis (HD-Mtx and HD-AraC) was given, demonstrated favorable outcome in comparison to historical controls. However, the patients with biological risk factors, such as translocation of bcl2 and myc oncogenes or and/or high BCL2 and MYC expression or deletion 17p and/or high P53 expression had significantly higher risk of death, as compared to patients without aberrations. The figures provide evidence for an unmet clinical need for the patients with biological risk factors, and underscore the importance of a clinical trial, where both biological and clinical risk factors play a role in the treatment planning. In this trial treatment intensity varies according to presence or absence of biological risk factors. All patients receive a prephase medication consisting of prednisone and vincristine and two cycles of R-CHOP and high dose (HD) methotrexate. Subsequently, depending on the biological risk factors either four additional cycles of R-CHOEP (standard arm with no risk factors) or four dose adjusted R-EPOCH courses (experimental arm with risk factors) are given, followed by one course of high dose cytarabine (Ara-C) and R. R-CHOEP courses should be given with a two-week and R-EPOCH with a three-week interval.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Aarhus University Hospital, Aarhus, , Denmark
Dept of Haematology, Rigshospitalet, Copenhagen, , Denmark
Dept of Haematology, Herlev Hospital, Copenhagen, Herlev, , Denmark
Dept haematology, Odense University hospital, Odense, , Denmark
Dept of Haematology, Sjaellands University hospital, Roskilde, Roskilde, , Denmark
Helsinki University Hospital Cancer Centre, Helsinki, , Finland
Keski-Suomen keskussairaala, Jyväskylä, , Finland
Kuopio University Hospital, Kuopio, , Finland
TAYS, Tampere, , Finland
Turku University Hospital, Syöpäklinikka, Turku, , Finland
Dept. of Oncology, Helse Bergen HF Haukeland sykehus, Bergen, , Norway
Oslo University Hospital, Oslo, , Norway
Dept. of Haematology and Oncology, Helse Stavander HF sykehuset, Stavanger, , Norway
Dept. of Oncology, Universitetssykehuset i Nord-Norge HF, Tromsø, , Norway
Dept of Oncology, St. Olavs hospital HF, Trondheim, , Norway
Skåne University Hospital, Lund, , Sweden
Name: Sirpa Leppa, prof
Affiliation: Helsinki University Hospital Cancer Centre
Role: PRINCIPAL_INVESTIGATOR