first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype MedDRA version: 20.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: LEVACT
Product Name: Bendamustine
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
CAS Number: 3543-75-7
Concentration unit: mg milligr
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy all following criteria to be enrolled in the study: • Patient with a first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype • Age of 61 years or older • No previous treatment for Hodgkin lymphoma • Ann Arbor stages: - II with mediastinum/thorax =0.33 or extranodal localization and with B symptoms - Or III - Or IV • Baseline 18-FDG PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion • ECOG performance status 0-2 • Adequate cardio-pulmonary function with LVEF = 50% • Adequate renal function with creatinine clearance = 40 mL/mn (MDRD formula) • For patients aged 70 years old and more, a Mini Nutritional Assessment (MNA) = 17 • A minimum life expectancy of 3 months • Negative HIV, HBV (anti-HBc negativity) and HCV serologies tests = 30 days before inclusion (except after vaccination) • Having previously signed a written informed consent • The patient must be covered by a social security system, if applicable • Men patient must agree to use an adequate method of contraception during the study treatment and until 6 months after the end of the study treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: Presence of any of the following will exclude a patient from enrollment: • Any other type of lymphoma including nodular lymphocyte predominant subtype • Any history of treated Hodgkin lymphoma • Contra-indication to any drug contained in the chemotherapy regimens • Any serious active disease (according to the investigator’s decision) • Poor hepatic function (total bilirubin level > 30 µmol/L or transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma • Poor bone marrow reserve as defined by leukocytes < 2 G/L or platelets < 100 G/L, unless related to bone marrow infiltration • Any history of cancer during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if they fulfil all the followings: (1) their disease was T1-T2a, N0, M0, with a Gleason score = 7, and a prostate specific antigen (PSA) = 10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e. prostatectomy or radiotherapy) = 2 years before Day 1 of Cycle 1, (3) at a minimum 2 years following therapy, they had no clinical evidence of prostate cancer and their PSA was undetectable if they underwent prostatectomy or < 1 ng/mL if they did not undergo prostatectomy • Severe metabolic disease interfering with normal application of protocol treatment as uncontrolled diabetes mellitus leading to impossibility to perform PET scan • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study • Adult under tutelage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of the study is to assess the Complete Metabolic Response (CMR) rate at the final evaluation after completion of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification (PET-CT-Based response).;Secondary Objective: The secondary endpoints are to evaluate: - The feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay). - The safety profile including immediate toxicities and non-tumor events. - Progression-free survival (PFS), disease-free survival (DFS) and overall survival (OS). - The geriatric assessment program (G8, reduced IADL, ADL, CIRS-G, MNA, QLQ-C30 and QLQ-ELD14). ;Primary end point(s): Complete Metabolic Response (CMR) Rate according to Lugano Classification (PET-CT-Based response).;Timepoint(s) of evaluation of this end point: at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival (PFS) - Disease Free Survival (DFS) - Overall survival (OS). - Patient reported outcome and questionnaires (PRO) (G8, reduced IADL, ADL, CIRS-G, MNA, QLQ-C30 and QLQ-ELD14). - safety ;Timepoint(s) of evaluation of this end point: At the end of the follow up = 2 years | — |
Countries
Belgium
Contacts
Public ContactFabienne Morand (Project Manager)
LYSARC
Outcome results
None listed