Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002532
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
Sponsor:
Hannover Medical School
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA A MULTICENTER TRIAL
Status:
UNKNOWN
Status Verified Date:
2002-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 combination chemotherapy in treating patients who have relapsed or refractory acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the toxic effects and feasibility of high-dose cytarabine and idarubicin in patients with refractory or relapsed acute lymphocytic leukemia ALL after a complete remission CR of less than 18 months II Determine the response of patients with ALL in first relapse after a CR of 18 months or more treated with a 2-phase re-induction regimen comprising prednisolone vindesine daunorubicin asparaginase intrathecal IT cytarabine IT dexamethasone and IT methotrexate followed by prednisolone ifosfamide high-dose methotrexate leucovorin calcium etoposide and cytarabine with a dose-escalation study of etoposide and cytarabine III Compare the effectiveness of these 2 regimens administered to these patients with the regimen administered to historic controls protocol GER-ALL-REZ- 0188
OUTLINE This is a dose-escalation multicenter study Patients are stratified by center duration of complete remission CR less than 18 months vs 18 months or more and refractory disease yes vs no Patients with refractory or relapsed disease after a CR of less than 18 months are treated on Regimen A Patients in first relapse after a CR of 18 months or more are treated on Regimen B Regimen A Patients receive idarubicin IV over 30 minutes followed by cytarabine IV over 3 hours on days 1-3 and filgrastim G-CSF subcutaneously SC daily beginning on day 5 and continuing until blood counts recover Regimen B 2-phase reinduction Patients receive oral prednisolone on days 1-21 vindesine IV and daunorubicin IV on days 1 8 and 15 asparaginase IV on days 7 8 14 and 15 and methotrexate intrathecally IT cytarabine IT and dexamethasone IT on days 1 and 8 When blood counts recover patients receive oral prednisolone and ifosfamide IV over 1 hour on days 1-4 high-dose methotrexate IV continuously on day 1 followed by standard leucovorin calcium rescue etoposide IV over 1 hour followed at least 8 hours later by cytarabine IV over 3 hours on days 3 and 4 and G-CSF SC beginning on day 6 and continuing until blood counts recover Cohorts of 6 patients or more receive escalating doses of etoposide and cytarabine until the maximum tolerated dose is determined
PROJECTED ACCRUAL Approximately 60 patients 30 per regimen will be accrued for this study within 2 years
OUTLINE This is a dose-escalation multicenter study Patients are stratified by center duration of complete remission CR less than 18 months vs 18 months or more and refractory disease yes vs no Patients with refractory or relapsed disease after a CR of less than 18 months are treated on Regimen A Patients in first relapse after a CR of 18 months or more are treated on Regimen B Regimen A Patients receive idarubicin IV over 30 minutes followed by cytarabine IV over 3 hours on days 1-3 and filgrastim G-CSF subcutaneously SC daily beginning on day 5 and continuing until blood counts recover Regimen B 2-phase reinduction Patients receive oral prednisolone on days 1-21 vindesine IV and daunorubicin IV on days 1 8 and 15 asparaginase IV on days 7 8 14 and 15 and methotrexate intrathecally IT cytarabine IT and dexamethasone IT on days 1 and 8 When blood counts recover patients receive oral prednisolone and ifosfamide IV over 1 hour on days 1-4 high-dose methotrexate IV continuously on day 1 followed by standard leucovorin calcium rescue etoposide IV over 1 hour followed at least 8 hours later by cytarabine IV over 3 hours on days 3 and 4 and G-CSF SC beginning on day 6 and continuing until blood counts recover Cohorts of 6 patients or more receive escalating doses of etoposide and cytarabine until the maximum tolerated dose is determined
PROJECTED ACCRUAL Approximately 60 patients 30 per regimen will be accrued for this study within 2 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 |
|---|---|---|---|
| CDR0000078432 | REGISTRY | None | None |
| EU-93001 | Registry Identifier | PDQ Physician Data Query | None |