Relapsing/Refractory ALK+ Anaplastic Large cell Lymphoma
Conditions
Brief summary
Cohort 1: Best objective response rate (CR+PR) within the first 24 weeks according to adapted Lugano 2014 Criteria for Malignant Lymphoma. In case of PET-positive residual masses after 24 weeks of induction treatment, a resection/biopsy must be performed by week 24. A residual mass proven to be pathologically negative for disease after resection or limited biopsy is considered as CR after discussion with the Coordinating investigator., Cohort 2: PFS. PFS is defined as the time since the inclusion in the trial to the first event among relapse and death (whatever the cause of death).
Detailed description
Efficacy: Cohort 1 -Time between the first dose of treatment and the confirmed CR/PR according to adapted Lugano 2014 Criteria for Malignant Lymphoma -Duration of response (CR/PR), defined as the time between the CR or PR according to adapted Lugano 2014 Criteria for Malignant Lymphoma (first met of these criteria) until confirmed progression or death Best objective response rate (CR+PR) according to adapted Lugano 2014 Criteria for Malignant Lymphoma - Progression-free survival (PFS), Efficacy : Cohort 2 : Overall survival PFS and OS in the subgroup of patients having received less than 12 months of ALK inhibitor or brentuximab Minimal Residual Disease blood level at various time-points, Safety in cohorts 1 and 2: Acute toxicity (NCI-CTCAE v5) during induction treatment, during maintenance treatment, and one month after the end of treatment Long-term toxicity (toxicity during the off-therapy period up to 5 years after study inclusion), Biology in cohorts 1 and 2: Anti-ALK antibody blood level at various time-points Biomarkers on tumor and its microenvironment, blood and bone marrow, including PDL1 and PDL2 expression, and tumor infiltrating lymphocytes and leucocytes populations/cytokines, at different time points.
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Best objective response rate (CR+PR) within the first 24 weeks according to adapted Lugano 2014 Criteria for Malignant Lymphoma. In case of PET-positive residual masses after 24 weeks of induction treatment, a resection/biopsy must be performed by week 24. A residual mass proven to be pathologically negative for disease after resection or limited biopsy is considered as CR after discussion with the Coordinating investigator., Cohort 2: PFS. PFS is defined as the time since the inclusion in the trial to the first event among relapse and death (whatever the cause of death). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Cohort 1 -Time between the first dose of treatment and the confirmed CR/PR according to adapted Lugano 2014 Criteria for Malignant Lymphoma -Duration of response (CR/PR), defined as the time between the CR or PR according to adapted Lugano 2014 Criteria for Malignant Lymphoma (first met of these criteria) until confirmed progression or death Best objective response rate (CR+PR) according to adapted Lugano 2014 Criteria for Malignant Lymphoma - Progression-free survival (PFS), Efficacy : Cohort 2 : Overall survival PFS and OS in the subgroup of patients having received less than 12 months of ALK inhibitor or brentuximab Minimal Residual Disease blood level at various time-points, Safety in cohorts 1 and 2: Acute toxicity (NCI-CTCAE v5) during induction treatment, during maintenance treatment, and one month after the end of treatment Long-term toxicity (toxicity during the off-therapy period up to 5 years after study inclusion), Biology in cohorts 1 and 2: Anti-ALK | — |
Countries
Denmark, France
Outcome results
None listed