Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488709
Status:
COMPLETED
Last Update Posted:
2008-11-18
First Post:
2007-06-01
Brief Title:
Fludarabine Cytarabine Topotecan in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
FLAT Fludarabine Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2008-11
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:
FLAT
Brief Summary:
The study is designed with drugs used frequently in the treatment of AML but with a new combination less toxicand effective in AML multidrug resistant
Justification
The AML patients with primary resistance or relapsed in the first 12 months after CR have second line chemotherapy low response rate
These patients with AML with primary resistance or relapse that reach remission after a rescue treatment have an interval free survival and a global survival very short
Probably the resistance to the treatments is in relation to different forms expression of the MDR
Complete remission is considered valid evaluation because every patient who should obtain a CR can be considered to be eligible for a possible curative treatment Ara-C administration to high doses or the TPH treatment
Justification
The AML patients with primary resistance or relapsed in the first 12 months after CR have second line chemotherapy low response rate
These patients with AML with primary resistance or relapse that reach remission after a rescue treatment have an interval free survival and a global survival very short
Probably the resistance to the treatments is in relation to different forms expression of the MDR
Complete remission is considered valid evaluation because every patient who should obtain a CR can be considered to be eligible for a possible curative treatment Ara-C administration to high doses or the TPH treatment
Detailed Description:
It is a protocol opened multicentric led to end to increase a the rate of complete responses b the duration of the response c the free survival of disease and d the global survival
The included subjects will be patients with primary or secondary AML that they have not achieved the CR after the standard treatment with an anthracycline or derivative associated with Ara-C or have relapsed in the first 12 months after having achieved the RC Also patients with AML that for any reason they could not receive the standard treatment with anthracycline and Ara-C will be included
Cycle of induction The patients will be treated by FLAT according to the following scheme
FLUDARABINE 30 mgm2 iv In 1 hour on the 1st to 4
CITARABINE 2 gm2 iv In 4 hours four hours after finishing the fludarabine on the 1st to 4
TOPOTECAN 15 mgm2 iv In 4 hours four hours after finishing the cytarabine on the 1st to 4
When the patient starts recovering the hematological counts and providing that has not blasts in the peripheral blood SP he will become a medullar revision MO
If MO presents severe hypocellularity without blastsno therapeutic measurement will take and there will repeat revisions weekly and MDRs study up to the CR or the blasts appearance
If in MO persist blasts 5 but have diminished less than 50 of the initial number the induction will be continued by the FLATs second shift
If in MO persists more than 50 of blasts of the initial number the patient goes out of the protocol and it will be treated as an agreement by the criterion of the center
The patients who have managed to enter CR will receive a cycle of consolidation as soon as possible and always within 2 months from the day in which they received first FLATs dose The cycle of consolidation consists of another FLATs scheme to the same doses
The included subjects will be patients with primary or secondary AML that they have not achieved the CR after the standard treatment with an anthracycline or derivative associated with Ara-C or have relapsed in the first 12 months after having achieved the RC Also patients with AML that for any reason they could not receive the standard treatment with anthracycline and Ara-C will be included
Cycle of induction The patients will be treated by FLAT according to the following scheme
FLUDARABINE 30 mgm2 iv In 1 hour on the 1st to 4
CITARABINE 2 gm2 iv In 4 hours four hours after finishing the fludarabine on the 1st to 4
TOPOTECAN 15 mgm2 iv In 4 hours four hours after finishing the cytarabine on the 1st to 4
When the patient starts recovering the hematological counts and providing that has not blasts in the peripheral blood SP he will become a medullar revision MO
If MO presents severe hypocellularity without blastsno therapeutic measurement will take and there will repeat revisions weekly and MDRs study up to the CR or the blasts appearance
If in MO persist blasts 5 but have diminished less than 50 of the initial number the induction will be continued by the FLATs second shift
If in MO persists more than 50 of blasts of the initial number the patient goes out of the protocol and it will be treated as an agreement by the criterion of the center
The patients who have managed to enter CR will receive a cycle of consolidation as soon as possible and always within 2 months from the day in which they received first FLATs dose The cycle of consolidation consists of another FLATs scheme to the same doses
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 |
|---|---|---|---|
| FLAT | None | None | None |