Hodgkin Lymphoma MedDRA version: 20.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ADCETRIS - 50 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO
Product Name: ADCETRIS
Product Code: [NA]
Pharmaceutical Form:
Sponsors
CENTRE ANTOINE LACASSAGNE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever IPS prognostic groups accepted 2.Stages IIB to IV B 3.Age 60-80 years included 4.Patient not previously treated 5.ECOG = 2 6.Patient with adequate organ function: •Absolute neutrophil count (ANC) = 1.5 x 109/L •Haemoglobin = 9 g/dL •Platelets (PTL) = 100 x 109/L •AST - ALAT = 2.5x ULN •Bilirubin = 1.5 x ULN •Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1.Patients aged less than 60 years. 2.Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 3.Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML. 4.Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication. 5.Symptomatic sensory or motor peripheral neuropathy. 6.Concurrent use of other investigational agents. In case of previous participation to a Clinical trial, a period of 30 days will be observed after the end of the previous Clinical Trial and before the inclusion in HALO study 7.Chemotherapy, biologics, and/or other treatment with immunotherapy not completed at least 4 weeks prior to first dose of study drug. 8.Patient who had major surgery less than 30 days before start of treatment 9.Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose. 10.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of BV. 11.Patient presenting an uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody or HIV or HCV serology positivity. In case of HBc positive serology, a PCR could be performed in order to determine viral load. Patients with viral load defined as negative could be included. oA prophylactic treatment will be strongly recommended (see HALO Study protocol, paragraph 6.2.3, page 36) 12.Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions, or laboratory abnormalities that would interfere, in the judgment of the investigator and/or sponsor, with the ability to comply with the study protocol. 13.Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl. 14.Known history of any of the following cardiovascular conditions •Myocardial infarction within 2 years of enrollment •New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 12) •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 15.Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% 16.People particularly vulnerable including: •Person deprived of liberty •Adult patient entitled to protection of law
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: To evaluate the tolerability and toxicity of Be-BV association. Phase 2: To evaluate the efficacy in terms of Response Rate after treatment completion of Be-BV association.;Secondary Objective: ¿ To evaluate the efficacy in terms of: Progression Free Survival at 3 years Event Free Survival at 3 years Overall Survival at 3 years ¿ To evaluate the efficacy in terms of Complete Response Rate after two Be-BV cycles of Be-BV association ¿ To evaluate the feasibility of the treatment;Primary end point(s): Phase 1: Evaluation of frequency and grades of toxicity using the NCI CTCAE v4.03 classification Phase 2: Response Rate after treatment completion using modified IHP criteria with the five-point scale Deauville criteria as interpretation Key for end of treatment PET scan.;Timepoint(s) of evaluation of this end point: 2 years and six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿Rate at 3 years and median of Progression Free Survival ¿Rate at 3 years and median of Event Free Survival ¿Rate at 3 years and median of Overall Survival ¿Control disease rate after two Be-BV cycles by using percentage of PET negative after two Be-BV cycles. ¿Prevalence of patient receiving the whole treatment courses (6 cycles) ;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
France, Italy
Contacts
Public ContactChristine LOVERA
CENTRE ANTOINE LACASSAGNE
Outcome results
None listed