FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
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
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 mg/m2 i.v. (In 1 hour) on the 1st to 4.
- CITARABINE, 2 g/m2 i.v. (In 4 hours), four hours after finishing the fludarabine, on
the 1st to 4.
- TOPOTECAN, 1,5 mg/m2 i.v. (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 blasts,no therapeutic measurement will
take and there will repeat revisions weekly and MDR's study up to the CR or the blasts
- If in MO persist blasts (>5 %) but have diminished less than 50 % of the initial
number, the induction will be continued by the FLAT's 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 FLAT's dose.
The cycle of consolidation consists of another FLAT's scheme to the same doses.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To treat with the combination FLAT patients with acute myeloid leukaemia that they present a primary resistance
Bueno Javier, Dr
Hospital Vall d'Hebron
Spain: Ministry of Health