recurrent / refractory follicular lymphoma MedDRA version: 24.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Zydelig
Product Name: Zydelig
Product Code: [IMP1]
Pharmaceutical Form: Capsule, hard
Current Sponsor code: IMP1
Other descriptive name: ZYDELIG® (IDELALISIB)
Concentration unit: mg millig
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with grade 1, 2 or 3a positive CD20 FL confirmed histologically according to the WHO 2017 classification, relapsed or refractory; • Patients aged = 18 years; • Patients already treated for the FL with at least 2 previous lines of chemotherapy in combination with any anti-CD20 antibody; • Patients in need of treatment for the presence of at least one of the following criteria: - bulky nodal or extra-nodal disease (with the exception of the spleen) defined as a mass with a diameter greater than 7 cm or involving at least 3 nodal or extra-nodal sites, each of them having a diameter greater than or equal to 3 cm ; - at least one systemic symptom (fever> 38 ° C of uncertain etiology or nocturnal sweating or weight loss of more than 10% of body weight in the previous 6 months); - symptomatic splenomegaly; - organ compression syndrome (in particular, of the orbits, of the urethra, of the gastrointestinal tract, of the biliary tract); - cytopenias related to lymphoma (hemoglobin 1,500 / mm3, platelets> 75,000 / mm3, hemoglobin> 8 , 0 g / dL; • Ability and willingness to adhere to the schedule of the study with regard to the planned visits and to everything else provided for by the protocol; • Ability to understand how much the study provides and voluntary signing of a written informed consent form; • Patients with the ability to swallow capsules and tablets; • Life expectancy = 2 months; • Female and male patients: readiness to follow a contraceptive plan, without interruption, from 28 days before the start of treatment (screening phase) up to 18 months after the end of treatment; • Male patients: refrain from giving the semen or sperm for the duration of the treatment and up to 18 months after the interruption of the same; • Female patients: regularly undergo pregnancy tests for the duration of the study. Invia commenti Cronologia Salvate Community 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 43 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: • Patients diagnosed with grade 3b FL or FL with evidence of transformation into high-grade non-Hodgkin's lymphoma; • Patients with involvement of the central or leptomeningeal nervous system by the lymphoma; • Major surgery within 28 days prior to signing informed consent; • Positive serology for HBV or evidence of active infection (HBsAg + or HBsAg patients with anti-HBs / anti-HBc positive antibodies and measurable viral DNA); if the viral DNA is negative or unmeasurable, the patient is eligible to study if HBsAg-; • Positive HVC viral RNA; • HIV seropositivity, regardless of viral load; • History of liver damage induced by pharmacological treatment, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic hepatopathy, non-alcoholic steatohepatitis, primary biliary cirrhosis, concomitant extrahepatic obstruction by cholelithiasis, liver cirrhosis or portal hypertension; • History of pneumonia induced by pharmacological treatment; • Concomitated inflammatory bowel pathology; • Concomitant addiction to drugs or alcohol; • Life expectancy 2.5 times the upper limit of normal (except for changes due to the involvement of the liver by the lymphoma ); total bilirubin> 1.5 mg / dL (except for patients with Gilbert's syndrome or compression of the biliary tree by the neoplastic masses); creatinine clearance <30 mL / min; • Uncontrolled intercurrent diseases; • Known hypersensitivity or allergy to murine products or to any of the study drugs; • Pregnancy or breastfeeding, or reluctance to adopt adequate contraception; • Presence of any other serious medical condition, abnormal laboratory values ¿¿or psychiatric condition that would prevent the patient from giving informed consent by signing the consent form or that at the clinician's judgment would expose the patient to unacceptable risk if he participated in the study; • Any evidence of bacterial, viral or fungal infection in progress.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluate the antitumor efficacy of the GAUDEALIS (idelalisib / obinutuzumab) regimen in terms of clinical response.;Secondary Objective: - Evaluate the efficacy of the GAUDEALIS combination in terms of progression-free survival (PFS) and overall survival (OS) - Evaluate the safety profile of the GAUDEALIS combination and patient compliance with treatment.;Primary end point(s): Primary endpoint - Overall clinical response rate (ORR), assessed by the center investigator at the end of induction treatment (EOI) of patients with the combination chemo-free idelalisib and obinutuzumab. The ORR is defined by the proportion of patients with at least one partial response (PR) to the EOI, assessed according to the criteria of Lugano 2014.;Timepoint(s) of evaluation of this end point: They are detected at the end of the induction treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Global survival (OS), calculated from the beginning of the experimental therapy to death for any reason; the patients alive and those lost to follow-up will be censored on the date of the last available control;; Disease-free survival (PFS), calculated from the beginning of the experimental therapy to the progression or relapse of illness or death for any cause; patients responsive to treatment and those lost to follow-up will be censured on the date of the last available control; Abandonment rate of study participants; Hospitalization rate during the study; Patients' compliance with oral treatment; Frequency of any adverse event (AE) that registers during and immediately after the end of treatment; Frequency and type of any serious adverse event (SAE);Timepoint(s) of evaluation of this end point: calculated from the beginning of the experimental therapy to death due to any cause; calculated from the beginning of the experimental therapy to the progression or relapse of illness or death from any cause; during the study; during the study; during the study; during and immediately after the end of treatment; during the study | — |
Countries
Italy
Contacts
Public ContactArea start up
Fondazione Italiana Linfomi Onlus
Outcome results
None listed