Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma
- Registration Number
- NCT03890289
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Brief Summary
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease \[no response or response lasting less than 6 months at any previous line of treatment\] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.
- Detailed Description
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease \[no response or response lasting less than 6 months at any previous line of treatment\] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.
Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on day 1, 8, 15 of the first cycle, then repeated on day 1 of each subsequent cycle, for 6 cycles (each cycle is completed in 28 days). Idelalisib will be given concomitantly with obinutuzumab and on a daily 150 mg bid schedule. For patients achieving at least a partial response at the end of induction, a maintenance phase with obinutuzumab is scheduled (on day 1 every two months for two years or until progression or unacceptable toxicity, whichever comes first) If one of the two drugs has to be permanently discontinued due to any cause, patient may continue treatment with the other agent if it is judged to be a clinical benefit. Patients with at least a stable disease will enter the follow-up phase and will be followed with repeated CT scans every six months for two years or until death/progression occurs (whichever comes firsts).
Patients with progressive disease, whenever progression is documented, will enter a survival follow up period of two years after PD was documented. These patients are however considered evaluable for OS.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Idelalisib Plus Obinutuzumab Obinutuzumab Single arm: Regimen: GAUDEALIS q28 days * Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle) * Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward) * Idelalisib Dose: 150 mg BID oral Daily (24 weeks) Idelalisib Plus Obinutuzumab Idelalisib Single arm: Regimen: GAUDEALIS q28 days * Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle) * Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward) * Idelalisib Dose: 150 mg BID oral Daily (24 weeks)
- Primary Outcome Measures
Name Time Method Primary Endpoint - Overall Response Rate (ORR) Six months after the start of treatment Investigator's assessed Overall response rate at the end of induction phase of patients treated with a chemo-free combination with obinutuzumab and idelalisib. Overall response rate is defined as the proportion of patients with at least a partial response according with 2014 Lugano criteria.
- Secondary Outcome Measures
Name Time Method Secondary Endpoints 1 - Overall Survival (OS) Rate Up to 24 months from the start of treatment Overall survival (OS) rate, measured from the date of starting therapy to the date of death from any cause. Patients alive and patients who are lost to follow up at the time of the final analysis will be censored at the date of the last contact.
Secondary Endpoints 2 - Progression-free Survival (PFS) Rate Up to 24 months from the start of treatment Progression-free survival (PFS) rate: measured from the date of starting therapy to the date of disease progression, relapse or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last assessment date. Patients who will have no tumor assessment after the start of therapy due to interruption of both drugs will be considered failures at the date of treatment interruption in the PFS analysis
Secondary Endpoints 3 - Patients' Withdrawal Rate Up to 24 months from the start of treatment patients' withdrawal rate, incidence and nature of any severe adverse events hospitalization rate throughout the study, and patients' compliance to oral treatment, incidence of any adverse events occurring during and right after treatment
Trial Locations
- Locations (4)
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
🇮🇹Firenze, Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
🇮🇹Novara, Italy
Azienda sanitaria-universitaria integrata Trieste (ASUITS) - SC Ematologia
🇮🇹Trieste, Italy
Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
🇮🇹Bologna, Italy