FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
18 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
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
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 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
appearance.
- 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.
Inclusion Criteria:
1. Subjects of 18 years of age or major, with diagnosis of primary or secondary AML,
confirmed cytologically, that fulfill one of the following conditions:
- Do not reach a CR after the conventional treatment.
- Relapse in the first 12 months after a CR. During remission, patients can have
be treated by a transplant. The relapse is defined as the presence of blasts in
peripheric blood or the presence of >5 % of blasts in MO.
- Not participation in a clinical trial.
2. ECOG < o = 2
3. Considered suitable patients for an intensive chemotherapy
4. Informed consent
Exclusion Criteria:
1. Pelvic or spinal radiotherapy in 4 weeks before the incorporation in the protocol.
2. Acute promyelocytic leukaemia
3. First line chemotherapy for AML which has contained fludarabine or topotecan.
4. Active or chronic hepatitis or hepatic cirrhosis.
5. Positivity known to the virus of the human immunodeficiency (HIV)
6. Pregnant or breastfeeding patients.
7. Patients with deterioration of the functions hepatic or renal, defined for the
following values base them of laboratory:
- AST or ALT >2,5 times the top limit of the normality of the center (LSNC)
- Alkaline phosphatase >2,5 times the LSNC
- Total bilirubin value >2 times the LSNC
- Creatinine value >2 times the LSNC after a suitable hydration
8. Precedents of intervention of major surgery in 2 weeks before the incorporation in
the protocol.
9. Patients with disease serious or not controlled (for example not controlled diabetes,
infection, hypertension, etc.).
10. Patients who have received other cytotoxic drugs (except hydroxyurea to reduce the
leucocytosis) as treatment of the current relapse or of the resistance, in 4 weeks
before the protocol.
11. Patients with hypersensitivity known to someone of the drugs of the protocol.
12. Patients treated previously with growth factors with purposes of sensibilization.
13. Patients with psychological, intellectual or sensitive dysfunction that can reduce
his capacity of comprehension and fulfillment of the protocol.
14. Patients treated before with FLAT.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To treat with the combination FLAT patients with acute myeloid leukaemia that they present a primary resistance
Outcome Time Frame:
one month
Principal Investigator
Bueno Javier, Dr
Investigator Role:
Study Chair
Investigator Affiliation:
Hospital Vall d'Hebron
Authority:
Spain: Ministry of Health
Study ID:
LAMR 2003
NCT ID:
NCT00488709
Start Date:
May 2003
Completion Date:
April 2007
Related Keywords:
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia
- Multi Drug Resistance
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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