Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03793478
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2019-01-02
Brief Title:
Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia AML a Cancer of the Blood
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 12 Multicenter Dose-Escalating Study To Evaluate the Safety Pharmacokinetics Pharmacodynamics and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy and as a Single-Agent Continuation Therapy in Pediatric RelapsedRefractory AML Subjects Aged 1 Month to 18 Years and Young Adults Aged up to 21 Years With FLT3-ITD Mutations
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Quizartinib is an experimental drug It is not approved for regular use It can only be used in medical research
Children or young adults with a certain kind of blood cancer FLT3-ITD AML might be able to join this study if it has come back after remission or is not responding to treatment
Children or young adults with a certain kind of blood cancer FLT3-ITD AML might be able to join this study if it has come back after remission or is not responding to treatment
Detailed Description:
The medical condition being investigated is relapsed or refractory AML in participants aged 1 month to 21 years with Feline McDonough Sarcoma FMS-like tyrosine kinase 3 FLT3-internal tandem duplication ITD mutations FLT3-ITD AML following failure of front-line intensive chemotherapy
The trial will be conducted in multiple phases An independent data monitoring committee DMC will protect the rights safety and well-being of participants by monitoring the progress and results The DMC will comprise qualified physicians and scientists who are not Investigators in the study and not otherwise directly associated with the Sponsor and will be convened at the end of Phase 1
A Dose EscalationDe-escalation Phase
Number of participants is determined by age group Participants will be enrolled by dose-level to determine the recommended Phase 2 dose RP2D of quizartinib for pediatric participants that provides similar exposure to adult patients treated at the target adult dose of 60 mg orally once daily
B Dose-Expansion Phase
Participants will receive the RP2D of quizartinib for their respective age group
During both dose escalation and dose expansion phases participants will receive
Re-Induction Therapy
Intrathecal IT triple chemotherapy prophylaxis prior to and between cycles
In re-induction Cycles 1 and 2 fludarabinecytarabine FLA followed by quizartinib as a single agent
Allogeneic Hematopoietic Stem Cell Transplantation HSCT Period
After re-induction therapy participants will be evaluated for eligibility to undergo allogeneic hematopoietic stem cell transplant HSCT Eligible participants may receive a single 28-day cycle of consolidation therapy standard of care chemotherapy with or without quizartinib if an allogeneic HSCT is not available immediately The options for consolidation therapy are as follows
High intensity chemotherapy with quizartinib or
Low intensity chemotherapy alone or
Low intensity therapy with quizartinib as a single agent
Continuation Therapy
Participants in remission after HSCT or who are not eligible for HSCT but achieve at least a partial remission PR after re-induction will receive up to 12 continuous 28-day cycles of quizartinib continuation therapy at the same dose received during re-induction in the dose expansion phase
Long-term Follow-up
The long-term follow-up phase begins upon completion of 12 cycles of quizartinib Continuation Therapy or permanent discontinuation of quizartinib at any time After completion of the 30-day safety follow-up visit subsequent visits will occur at the following frequencies to assess survival and anti-leukemic treatments
every 3 months for the first 2 years and then
once a year thereafter until the last participant enrolled has been followed for three years from the date of enrollment
The trial will be conducted in multiple phases An independent data monitoring committee DMC will protect the rights safety and well-being of participants by monitoring the progress and results The DMC will comprise qualified physicians and scientists who are not Investigators in the study and not otherwise directly associated with the Sponsor and will be convened at the end of Phase 1
A Dose EscalationDe-escalation Phase
Number of participants is determined by age group Participants will be enrolled by dose-level to determine the recommended Phase 2 dose RP2D of quizartinib for pediatric participants that provides similar exposure to adult patients treated at the target adult dose of 60 mg orally once daily
B Dose-Expansion Phase
Participants will receive the RP2D of quizartinib for their respective age group
During both dose escalation and dose expansion phases participants will receive
Re-Induction Therapy
Intrathecal IT triple chemotherapy prophylaxis prior to and between cycles
In re-induction Cycles 1 and 2 fludarabinecytarabine FLA followed by quizartinib as a single agent
Allogeneic Hematopoietic Stem Cell Transplantation HSCT Period
After re-induction therapy participants will be evaluated for eligibility to undergo allogeneic hematopoietic stem cell transplant HSCT Eligible participants may receive a single 28-day cycle of consolidation therapy standard of care chemotherapy with or without quizartinib if an allogeneic HSCT is not available immediately The options for consolidation therapy are as follows
High intensity chemotherapy with quizartinib or
Low intensity chemotherapy alone or
Low intensity therapy with quizartinib as a single agent
Continuation Therapy
Participants in remission after HSCT or who are not eligible for HSCT but achieve at least a partial remission PR after re-induction will receive up to 12 continuous 28-day cycles of quizartinib continuation therapy at the same dose received during re-induction in the dose expansion phase
Long-term Follow-up
The long-term follow-up phase begins upon completion of 12 cycles of quizartinib Continuation Therapy or permanent discontinuation of quizartinib at any time After completion of the 30-day safety follow-up visit subsequent visits will occur at the following frequencies to assess survival and anti-leukemic treatments
every 3 months for the first 2 years and then
once a year thereafter until the last participant enrolled has been followed for three years from the date of enrollment
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-002919-18 | EUDRACT_NUMBER | None | None |