Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003178
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2000-06-02
Brief Title:
Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia A POG Phase II Study
Status:
COMPLETED
Status Verified Date:
2014-07
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the complete response rate in children with primary refractory or recurrent acute myeloid leukemia AML or secondary AML treated with idarubicin and cladribine Refractory AML stratum closed as of 4301 Secondary AML stratum closed as of 040202
Compare the remission reinduction rates in children who relapse at 1 year or earlier vs more than 1 year from time of initial remission
Determine the toxic effects of this regimen in this patient population
OUTLINE Patients are stratified according to disease characteristics primary or secondary acute myeloid leukemia AML with first untreated relapse vs primary refractory AML Refractory AML stratum closed as of 4301 Secondary AML stratum closed as of 040202
Patients receive idarubicin IV over 15 minutes on days 1-3 cladribine IV over 2 hours on days 1-5 and filgrastim G-CSF subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 51-102 patients will be accrued for this study within 3 years
Determine the complete response rate in children with primary refractory or recurrent acute myeloid leukemia AML or secondary AML treated with idarubicin and cladribine Refractory AML stratum closed as of 4301 Secondary AML stratum closed as of 040202
Compare the remission reinduction rates in children who relapse at 1 year or earlier vs more than 1 year from time of initial remission
Determine the toxic effects of this regimen in this patient population
OUTLINE Patients are stratified according to disease characteristics primary or secondary acute myeloid leukemia AML with first untreated relapse vs primary refractory AML Refractory AML stratum closed as of 4301 Secondary AML stratum closed as of 040202
Patients receive idarubicin IV over 15 minutes on days 1-3 cladribine IV over 2 hours on days 1-5 and filgrastim G-CSF subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 51-102 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| CDR0000065993 | OTHER | Clinical Trialsgov | None |
| POG-9720 | OTHER | None | None |
| COG-P9720 | OTHER | None | None |