Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748171
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-01-20
Brief Title:
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin InO in Children 1 to 18 Years With First Relapse ALL
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PROSPECTIVE RANDOMIZED OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA
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:
None
Brief Summary:
This prospective randomized multicenter open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants between 1 and 18 years with High Risk HR first bone marrow relapse CD22-positive BCP ALL and to evaluate the safety and tolerability PK and long-term efficacy Treatment with study intervention will end after induction therapy follow-up will continue for up to 5 years from randomization
Detailed Description:
This prospective randomized multicenter open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants between 1 and 18 years with HR first bone marrow relapse CD22-positive BCP ALL and to evaluate the safety and tolerability PK and long-term efficacy Treatment with study intervention will end after induction therapy follow-up for efficacy and safety will continue for up to 5 years from randomization
End of Treatment is defined as occurring upon recovery from 1 cycle of study therapy Day 28 2 days or one day before initiation of new anticancer therapy whichever occurs first
Approximately 100 participants will be randomized 21 to receive 1 cycle of either InO monotherapy or ALLR3 block 1 therapy during induction
After completion of induction therapy ie study therapy it is anticipated that the majority of responding participants will proceed immediately to consolidation therapy Non-responders are expected to proceed with salvage therapy at the investigators discretion Participants responding to induction therapy are expected to proceed to SOC consolidation therapy upon recovery of blood counts but no sooner than 7 days after last dose of study intervention
All participants responders and non-responders will proceed to long-term follow-up for this study All subsequent anticancer therapy will be determined by the treating physician
End of Treatment is defined as occurring upon recovery from 1 cycle of study therapy Day 28 2 days or one day before initiation of new anticancer therapy whichever occurs first
Approximately 100 participants will be randomized 21 to receive 1 cycle of either InO monotherapy or ALLR3 block 1 therapy during induction
After completion of induction therapy ie study therapy it is anticipated that the majority of responding participants will proceed immediately to consolidation therapy Non-responders are expected to proceed with salvage therapy at the investigators discretion Participants responding to induction therapy are expected to proceed to SOC consolidation therapy upon recovery of blood counts but no sooner than 7 days after last dose of study intervention
All participants responders and non-responders will proceed to long-term follow-up for this study All subsequent anticancer therapy will be determined by the treating physician
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 |
|---|---|---|---|
| 2022-000186-40 | EUDRACT_NUMBER | Alias Study Number | None |
| EU PIP Study 2 | OTHER | None | None |