CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
Topotecan +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00488709
NCT00488709Phase 4Completed

FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

PETHEMA Foundation·interventional·Posted Jun 20, 2007·Updated Nov 18, 2008

In Brief

A Phase 4 clinical trial evaluating Topotecan, Fludarabine, and 1 other intervention for Acute Myeloid Leukemia. Completed, enrolled 47 participants across 16 sites.

Detailed Summary

The study is designed with drugs used frequently in the treatment of AML, but with a new combination less toxic,and 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2007
Enrollment StartMay 1, 2003
Study CompletionApr 1, 2007
TodayJul 2, 2026
Posted 19.0 years ago

Interventions

Topotecandrug

Fludarabinedrug

Cytarabinedrug