Idelalisib (I) in combination with Obinutuzumab (G) for the treatment of patients with relapsed / refractory follicular lymphoma: multicentric phase II single arm study.
- Conditions
- recurrent / refractory follicular lymphomaMedDRA version: 24.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2018-001229-18-IT
- Lead Sponsor
- FONDAZIONE ITALIANA LINFOMI ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 43
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 <10 g / dL, and / or platelets <100,000 / mm3 and / or neutrophils <1,500 / mm3);
- serous effusion of the pleura or peritoneum;
- High LDH.
• Eastern Cooperative Oncology Group (ECOG) performance status
(PS) = 2;
• Adequate haematological function (unless the anomaly is due to the underlying disease) independent of transfusions in the 28 days preceding the signing of the informed consent, defined as follows: neutrophils> 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
• 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 <6 months;
• Prevalent neoplasms other than FL in the last 10 years, except for localized carcinoma of non-melanomatous or squamous skin or in situ carcinoma of the uterine cervix;
• Presence of any of the following alterations in laboratory values: liver enzymes (AST / SGOT and / or ALT / SGTP)> 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>- Evaluate the safety profile of the GAUDEALIS combination and patient compliance with treatment.;Primary end point(s): Primary endpoint<br>- 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 Outcome Measures
Name Time Method