Hodgkin Lymphoma not previously treated MedDRA version: 12.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma
Conditions
Interventions
Product Name: Bleomycin
Pharmaceutical Form: Powder for solution for injection
Product Name: Prednisone
Pharmaceutical Form: Tablet
Product Name: Vincristine
Pharmaceutical Form: Solution for inject
Sponsors
CHU de Dijon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with a first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype - Age of 16 to 60 years - No previous treatment for Hodgkin lymphoma - Ann Arbor stages: IIB with mediastinum/thorax =0.33 or extra nodal localization III IV - Baseline 18-FDG PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion - ECOG performance status =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women • Men and women of childbearing potential not practicing an adequate method of contraception during the study treatment and at least 3 months after the last study drug administration • Any history of cancer or cancer treatment during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma • Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBs antibody without detectable anti HBc antibody. • HIV, HCV or HTLV serology positivity • Abnormal liver (bilirubin > 2,5 N) function unless abnormalities are due to Hodgkin lymphoma • Abnormal renal (Creatinin > 150 µmol/L) function unless abnormalities are due to Hodgkin lymphoma • Leukopenia < 2 G/L or thrombopenia <100 G/L unless abnormalities are due to Hodgkin lymphoma • Severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment: o LEVF<50% o Respiratory insufficiency prohibiting bleomycin use o Uncontrolled diabetes mellitus leading to impossibility to perform PET scan • Impossibility to perform a baseline PET (PET0) before randomization and treatment beginning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the non inferiority in term of progression free survival (PFS) of a therapeutic strategy driven by PET with a ABVD conventional dose chemotherapy for patients reaching a negative PET after 2 cycles of BEACOPPesc, compared to a treatment not monitored by early PET delivering 6 cycles of BEACOPPesc.;Secondary Objective: - Comparison of the response rate (after 4 cycles of chemotherapy and at end of treatment), the event free survival (EFS), the disease free survival (DFS) and the overall survival (OS) - Comparison of safety data in both arms including immediate toxicities, and secondary tumor and non tumor events. -Comparison of fertility parameters of patients under 45 year-old before and after treatment in both arms - Identification of biological parameters related to the Hodgkin Lymphoma cells and tumor microenvironnement, influencing the early response to treatment assessed by PET - Assessment of the influence of the genetic polymorphisms of cytokine and cytokin receptor involved in the lymphoma process, and enzyme genes involved in the drug metabolism, on the early response to treatment assessed by PET.;Primary end point(s): The primary endpoint is progression-free survival (PFS). PFS will be measured from the date of randomization to the date of first documented progression of the lymphoma in non-responding patients, relapse for CR patients or death from any cause without progression, whichever occurs first. Patients alive and free of progression or who are lost to follow-up will be censored at their last follow-up date. | — |
Countries
Belgium, France
Outcome results
None listed