Multicentric Phase II Trial, Prospective, Open, Single Group, to Discuss Induction Therapy With a Combination of Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy With Clofarabine and Low-dose Cytarabine for the Treatment of AML Patients Age Greater Than or Equal to 60 Years
This protocol corresponds to a multicenter, phase II, open, non randomized, designed to
determine the efficacy of clofarabine and low-dose cytarabine combination in AML patients
older than or equal to 60 years.
The trial is divided into pre-treatment and treatment (cycle / s of induction and
consolidation) periods.The induction cycle consist of clofarabine at 20 mg/m2/day
intravenously for 5 consecutive days plus cytarabine subcutaneously at 20 mg/m2/day for 14
consecutive days. If patients do not achieve CR they will receive a second course of
induction with the same pattern. Consolidation cycles consist of clofarabine intravenously
at 15 mg/m2/day for 5 consecutive days plus cytarabine at 20 mg/m2/day subcutaneously for 7
consecutive days. Patients will receive a maximum of 12 cycles of clofarabine and LDAC. The
monitoring phase of survival is made by clinical practice and will continue until all
patients have either died or survived two years after the end of treatment visit.
There will be 75 patients older than or equal to 60 years. Patients will be evaluated over
the following periods: Pre-treatment and treatment (induction and consolidation).
Pre-treatment phase: includes enrolment visit in which the patient completes the written
informed consent to participate in the study.
There will be a selection of patients who have given their written informed consent to join
the clinical trial. They must meet all the inclusion criteria and no exclusion.
Treatment phase: Patients should begin treatment within 14 days after signing the informed
consent form (ICF). Selection period begins when the ICF is signed and the inclusion period
begins when the patient first receives the study drug (ie Day 1 of the induction cycle).
Safety will be evaluated by monitoring all adverse events haematological and not
haematological related with the drug's study.
The final visit of treatment will take place at least 45 days after the last dose of study
Patients who leave the study prematurely, should have the end of treatment visit within 2
weeks after the decision not to continue to administer the study drug. The final visit
should take place within 2 weeks after the visit of the last cycle of treatment.
Off protocol, after making the final visit of, all patients receiving at least one dose of
study drug will be subject to monitoring by normal clinical practice, for a minimum of two
years from the final visit or until his death
Follow up phase:
The maximum follow-up for all patients is 2 years from the final visit of the last patient
included and be conducted on a monthly basis during the first year and quarterly during the
second at least, notwithstanding that there may be more visits at discretion of each centre
or depending on the clinical features.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the efficacy in terms of complete responses of induction therapy and first-line consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more. The first efficacy objective is evaluate the overall remission rate (TRG), where general reference (RG) is defined as a patient who achieved complete remission (CR) or complete remission with inadequate platelet recovery (CPR).
Spain: Ministry of Health