Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469859
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2007-05-03
Brief Title:
Lestaurtinib Cytarabine and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study of Lestaurtinib CEP-701 in Combination With Chemotherapy in Young Patients With Relapsed or Refractory FLT3-mutant Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2017-02
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:
RATIONALE Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as cytarabine and idarubicin work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving lestaurtinib together with cytarabine and idarubicin may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of lestaurtinib when given together with cytarabine and idarubicin and to see how well they work in treating younger patients with relapsed or refractory acute myeloid leukemia
PURPOSE This phase III trial is studying the side effects and best dose of lestaurtinib when given together with cytarabine and idarubicin and to see how well they work in treating younger patients with relapsed or refractory acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine a safe tolerable and biologically active dose of lestaurtinib in combination with chemotherapy comprising cytarabine and idarubicin in younger patients with relapsed or refractory FLT3-mutant acute myeloid leukemia
Secondary
Determine the overall response rate in patients treated with this regimen
Optimize dosing of lestaurtinib based primarily on biologic activity rather than toxicity
Correlate the clinical response to this regimen with the ability to achieve adequate FLT3 plasma inhibitory activity levels and the in vitro sensitivity of pretreatment leukemic cells to lestaurtinib in these patients
Determine the mechanisms of resistance to lestaurtinib in these patients
Assess the feasibility of using rapid central determination of FLT3 mutation status at study entry to determine induction therapy in future upfront protocols
OUTLINE This is a multicenter dose-finding study of lestaurtinib followed by an efficacy study
Dose-finding phase
Course 1 Patients receive cytarabine IV over 2 hours twice daily on days 1-4 idarubicin IV over 15 minutes on days 2-4 and oral lestaurtinib twice daily on days 5-28 Patients achieving complete or partial response proceed to course 2
Cohorts of 6 patients receive escalating doses of lestaurtinib until a tolerable and biologically active dose TBAD is determined The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by plasma inhibitory activity PIA assay
Course 2 Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib at the dose determined in course 1 twice daily on days 5-28 Patients achieving complete or partial response proceed to continuation therapy
Continuation therapy Patients receive oral lestaurtinib twice daily on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Efficacy phase Once the TBAD is determined subsequent patients receive treatment as in course 1 and 2 with lestaurtinib at the TBAD Patients may also receive continuation therapy as in the dose-finding phase
Blood samples are collected periodically during study treatment for pharmacokinetic and PIA assays
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
Primary
Determine a safe tolerable and biologically active dose of lestaurtinib in combination with chemotherapy comprising cytarabine and idarubicin in younger patients with relapsed or refractory FLT3-mutant acute myeloid leukemia
Secondary
Determine the overall response rate in patients treated with this regimen
Optimize dosing of lestaurtinib based primarily on biologic activity rather than toxicity
Correlate the clinical response to this regimen with the ability to achieve adequate FLT3 plasma inhibitory activity levels and the in vitro sensitivity of pretreatment leukemic cells to lestaurtinib in these patients
Determine the mechanisms of resistance to lestaurtinib in these patients
Assess the feasibility of using rapid central determination of FLT3 mutation status at study entry to determine induction therapy in future upfront protocols
OUTLINE This is a multicenter dose-finding study of lestaurtinib followed by an efficacy study
Dose-finding phase
Course 1 Patients receive cytarabine IV over 2 hours twice daily on days 1-4 idarubicin IV over 15 minutes on days 2-4 and oral lestaurtinib twice daily on days 5-28 Patients achieving complete or partial response proceed to course 2
Cohorts of 6 patients receive escalating doses of lestaurtinib until a tolerable and biologically active dose TBAD is determined The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by plasma inhibitory activity PIA assay
Course 2 Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib at the dose determined in course 1 twice daily on days 5-28 Patients achieving complete or partial response proceed to continuation therapy
Continuation therapy Patients receive oral lestaurtinib twice daily on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Efficacy phase Once the TBAD is determined subsequent patients receive treatment as in course 1 and 2 with lestaurtinib at the TBAD Patients may also receive continuation therapy as in the dose-finding phase
Blood samples are collected periodically during study treatment for pharmacokinetic and PIA assays
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| COG-AAML06P1 | OTHER | Childrens Oncology Group | None |
| CDR0000543398 | OTHER | None | None |