Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003729
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study of Fludarabine Idarubicin Aracytine in Refractory or Relapsed ALL in Children
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Evaluate the complete response rate to combination fludarabine idarubicin and cytarabine in children with relapsed or refractory acute lymphocytic leukemia II Evaluate the safety and tolerance of this treatment in these patients III Evaluate the time to progression disease free survival and overall survival of these patients
OUTLINE This is an open label multicenter study Patients receive idarubicin IV over 1 hour on days 1-3 Fludarabine IV is administered over 30 minutes on days 1-5 Cytarabine IV is administered over 4 hours on days 1-5 If partial response is obtained patients receive a second course of treatment Patients receive a consolidation course in the absence of disease progression and unacceptable toxicity Idarubicin IV is administered over 1 hour on days 1 and 2 Fludarabine IV is administered over 30 minutes followed by cytarabine IV over 4 hours on days 1-5 Patients are followed every 3 months for 2 years or until death
PROJECTED ACCRUAL A total of 24-45 patients will be accrued for this study within 27 months
OUTLINE This is an open label multicenter study Patients receive idarubicin IV over 1 hour on days 1-3 Fludarabine IV is administered over 30 minutes on days 1-5 Cytarabine IV is administered over 4 hours on days 1-5 If partial response is obtained patients receive a second course of treatment Patients receive a consolidation course in the absence of disease progression and unacceptable toxicity Idarubicin IV is administered over 1 hour on days 1 and 2 Fludarabine IV is administered over 30 minutes followed by cytarabine IV over 4 hours on days 1-5 Patients are followed every 3 months for 2 years or until death
PROJECTED ACCRUAL A total of 24-45 patients will be accrued for this study within 27 months
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 |
|---|---|---|---|
| EORTC-58953 | None | None | None |