Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485947
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-15
Brief Title:
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Sponsor:
Princess Maxima Center for Pediatric Oncology
Organization:
Princess Maxima Center for Pediatric Oncology
Study Overview
Official Title:
Phase Ib Study Combining Dinutuximab Beta With Induction Chemotherapy Regimens in Patients With Newly Diagnosed High-risk Neuroblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
DBPilot
Brief Summary:
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta DB when combined with 2 different induction chemotherapy regimens named GPOH or rapid COJEC in newly diagnosed high-risk neuroblastoma patients The main question is
to assess the safety and tolerability and identifying the recommended phase II dose andor the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens
Participants will receive
GPOH dinutuximab beta infusion duration 10 mgm2 5 days 50 mgm2course in 21-day treatment intervals
Rapid COJEC dinutuximab beta infusion duration 10 mgm2 3 days 30 mgm2course in 10-day treatment intervals
to assess the safety and tolerability and identifying the recommended phase II dose andor the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens
Participants will receive
GPOH dinutuximab beta infusion duration 10 mgm2 5 days 50 mgm2course in 21-day treatment intervals
Rapid COJEC dinutuximab beta infusion duration 10 mgm2 3 days 30 mgm2course in 10-day treatment intervals
Detailed Description:
This study is a multicenter open-label dual-cohort Phase 1 study of DB combined with each of 2 different induction chemotherapy regimens in 2 cohorts When the recommended cumulative DB dose level has been defined for each of the chemotherapy regimens a confirmation cohort of 10 evaluable patients per cohort will be enrolled The maximum number of patients to be enrolled in the dose escalation and dose confirmation parts of the study combined will be 38 evaluable patients for both induction chemotherapy regimens
For each patient there will be a screening period of up to 21 days a treatment period consisting of approximately 126 days GPOH cohort or 80 days rapid COJEC cohort an end of treatment visit at the end of induction treatment and a post-discontinuation safety visit 30 days after the last administration of DB Patients will enter the follow up phase after completing the induction treatment We recommend to follow countrysite protocolguidelines for the management of the patients after the induction treatment eg High Risk-NeuroBLastoma HR-NBL-2 study EudraCT 2019-001068-31
There are two study periods
The first period lasts until the last patient has completed the end of treatment visit The analysis of these results will answer the primary endpoint of the study The planned duration for each patient enrolled is approximately 5 months and the total study duration is approximately 2 years
The second period lasts until the last patient has completed the follow up In this period data for exploratory endpoints are collected The plan is to report late toxicity mainly related to the high-dose chemotherapy when the last patient completed the end of study visit and in a further report the results of 3 and 5 years follow up
For each patient there will be a screening period of up to 21 days a treatment period consisting of approximately 126 days GPOH cohort or 80 days rapid COJEC cohort an end of treatment visit at the end of induction treatment and a post-discontinuation safety visit 30 days after the last administration of DB Patients will enter the follow up phase after completing the induction treatment We recommend to follow countrysite protocolguidelines for the management of the patients after the induction treatment eg High Risk-NeuroBLastoma HR-NBL-2 study EudraCT 2019-001068-31
There are two study periods
The first period lasts until the last patient has completed the end of treatment visit The analysis of these results will answer the primary endpoint of the study The planned duration for each patient enrolled is approximately 5 months and the total study duration is approximately 2 years
The second period lasts until the last patient has completed the follow up In this period data for exploratory endpoints are collected The plan is to report late toxicity mainly related to the high-dose chemotherapy when the last patient completed the end of study visit and in a further report the results of 3 and 5 years follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509673-22-00 | CTIS | None | None |