Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03703050
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2018-10-09
Brief Title:
Nivolumab for Pediatric and Adult RelapsingRefractory ALK for Evaluation of Response in Patients With Progressive Disease Cohort 1 or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse Cohort 2
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase II Trial of Nivolumab for Pediatric and Adult RelapsingRefractory Anaplastic Large Cell Lymphoma for Evaluation of Response in Patients With Progressive Disease Cohort 1 or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse Cohort 2
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIVO-ALCL
Brief Summary:
Prospective non-randomized single arm phase II trial with 2 cohorts of ALK ALCL treated with nivolumab
Detailed Description:
Prospective non-randomized single arm phase II trial with 2 cohorts of ALK ALCL treated with nivolumab
Cohort 1
Population relapsedrefractory ALK ALCL with progressive disease after treatment including chemotherapy and ALK inhibitor andor brentuximab vedotin
Primary endpoint ORR best objective response rate CRPR within the first 24 weeks assessed according to adapted Lugano 2014 response criteria for Lymphoma
Design A one-stage phase II trial with unacceptable ORR 40 and promising ORR 70 12 eligible and evaluable patients are required
Cohort 2 Population patients with a relapsedrefractory ALCL having achieved CR with a treatment including ALK-inhibitor or Brentuximab vedotin of at least 2 months and for whom HSCT is considered for their consolidation therapy In this case nivolumab for 24 months would be considered as consolidative immunotherapy instead as HSCT
Primary endpoint progression-free survival PFS A PFS rate 50 will be considered as unacceptable Design A four-stage phase II trial with unacceptable PFS rate 50 and promising PFS rate 75 A maximum of twenty-six patients will be included 4 at the 1st and 2nd stages 8 at the 3rd stage and 10 at the 4th stage
No more than one third of the included patients must have received more than 12 months of ALK inhibitor or brentuximab Thus the inclusion of these patients will be closed after 8 patients
Cohort 1
Population relapsedrefractory ALK ALCL with progressive disease after treatment including chemotherapy and ALK inhibitor andor brentuximab vedotin
Primary endpoint ORR best objective response rate CRPR within the first 24 weeks assessed according to adapted Lugano 2014 response criteria for Lymphoma
Design A one-stage phase II trial with unacceptable ORR 40 and promising ORR 70 12 eligible and evaluable patients are required
Cohort 2 Population patients with a relapsedrefractory ALCL having achieved CR with a treatment including ALK-inhibitor or Brentuximab vedotin of at least 2 months and for whom HSCT is considered for their consolidation therapy In this case nivolumab for 24 months would be considered as consolidative immunotherapy instead as HSCT
Primary endpoint progression-free survival PFS A PFS rate 50 will be considered as unacceptable Design A four-stage phase II trial with unacceptable PFS rate 50 and promising PFS rate 75 A maximum of twenty-six patients will be included 4 at the 1st and 2nd stages 8 at the 3rd stage and 10 at the 4th stage
No more than one third of the included patients must have received more than 12 months of ALK inhibitor or brentuximab Thus the inclusion of these patients will be closed after 8 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20182706 | OTHER | CSET number | None |