Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008697
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2001-01-13
Brief Title:
Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase III Trial of Infusional Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-04
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:
The purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic trioxide in the treatment of patients with relapsed or refractory acute promyelocytic leukemia APML In addition correlation between pharmacokinetic data and both therapeutic response and therapy-related toxicities will be sought
Detailed Description:
OUTLINE This is a dose-escalation study
Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day rest period Patients may receive up to 3 courses of treatment
Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose MTD or minimum effective dose MED is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity The MED is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response After the MTD or MED is determined an additional 20 patients are enrolled at this dose level
Patients are followed monthly for 6 months and every three months for an additional 15 years
Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day rest period Patients may receive up to 3 courses of treatment
Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose MTD or minimum effective dose MED is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity The MED is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response After the MTD or MED is determined an additional 20 patients are enrolled at this dose level
Patients are followed monthly for 6 months and every three months for an additional 15 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 |
|---|---|---|---|
| NCI-V98-1466 | None | None | None |
| WU-98-0185 | None | None | None |