relapsed or refractory Hodgkin lymphoma MedDRA version: 16.0 Level: PT Classification code 10020206 Term: Hodgkin's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Novartis Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pediatric patients between the ages of 6 and 17 years old with classical Hodgkin lymphoma 2.Patients must meet one of the following:a.Patients eligible for ASCT must have documented progression after high-dose chemotherapy followed by autologous stem cells transplantation (ASCT), b. Patients ineligible for ASCT must be refractory to or progressed after at least two prior chemotherapy regimens; note: prior treatment with brentuximab vedotin is permitted 3.Prior therapy with at least one gemcitabine-, vinorelbine-, or vinblastine-containing regimen 4.Progressive HL on or within 12 months following the last treatment administration 5.ECOG performance status ?2 Other protocol defined inclusion criteria may apply Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Concomitant anticancer therapy (monoclonal antibody, chemotherapy, or any investigational drug); 2. Concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry with the following exceptions: Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are allowed; 3.Radiotherapy within four weeks prior to study entry. Patients must have recovered from radiotherapy toxicities prior to study entry; 4. Prior therapy with mTOR inhbitors (e.g. sirolimus, temsirolimus, deforolimus); 5. Previous treatment with an PI3K or AKT inhibitors; Other protocol defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the overall response rate (ORR), defined as the percentage of patients who achieve a CR or PR according to the revised response criteria for malignant lymphoma;Secondary Objective: 1. Estimate time to response, duration of response 2. Estimate progression-free survival (PFS) 3. Estimate the disease control rate (DCR), defined as the percentage of patients who achieve a best overall response of CR, PR, or stable disease (SD), 4. Estimate overall survival (OS), 5. To evaluate pharmacokinetics 6. Safety;Primary end point(s): overall response rate (ORR);Timepoint(s) of evaluation of this end point: 6 months after Last patient first visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to response, duration of response 2. progression-free survival (PFS) 3. disease control rate (DCR) 4. overall survival (OS) 5. Everolimus exposure in terms of pre-dose concentration (Cmin), Dose-proportionality of Cmin Relationship between everolimus Cmin and the responses (CR or PR vs SD, PD etc., as defined for the primary analysis) 6. Incidence of adverse events, incidence of SAEs, change in vital signs, change in laboratory results (hematology, blood chemistry, urinalysis, coagulation, lipid profile, pregnancy tests);Timepoint(s) of evaluation of this end point: 1. 6 months after Last patient first visit 2. 6 months after Last patient first visit 3. 6 months after Last patient first visit 4. 18 months after Last patient last visit 5. 6 months after Last patient first visit 6. At the time of the primary analysis and upon LPLV | — |
Countries
France, Italy, Russian Federation, Spain, Turkey, United States
Contacts
Public ContactDepartamento Médico Oncología (GMO)
Novartis Farmcéutica S.A.
Outcome results
None listed