Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years
Primary outcome measure:
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).
Secondary outcome measures:
- To evaluate disease-free survival (DFS)
- Evaluate the overall survival (OS)
- To evaluate the safety and tolerability of clofarabine and duration, severity and relationship of adverse events (AEs) occurring during treatment
- To assess the rate of mortality at 30 days (ie, the incidence of deaths occurring between Day 1 and Day 30 of induction cycle)
- The incidence, intensity (according to the latest version of the CTCAE classification), duration, causality, severity and type of AA
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]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).
- To evaluate disease-free survival (DFS) [ Designated as safety issue: No ]
- Evaluate the overall survival (OS) [ Designated as safety issue: No ]
- To evaluate the safety [ Designated as safety issue: Yes ]
- To assess the rate of mortality at 30 days [ Designated as safety issue: No ]
- • The incidence, intensity (according to the latest version of the CTCAE classification), duration, causality, severity and type of AE [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Induction therapy with a combination of clofarabine and low-dose cytarabine followed by consolidation therapy with clofarabine and low-dose cytarabine
|Drug: Clofarabine Drug: Cytarabine|
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 drug administration.
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.
|Hospital General de Alicante.|
|Hospital de la Santa Creu i Sant Pau.|
|Hospital Durán i Reynals (Bellvitge).|
|Hospital Vall d' Hebron|
|ICO Hospital Germans Trias I Pujol.|
|Hospital Reina Sofía.|
|Hospital Juan Canalejo.|
|La Coruña, Spain|
|Hospital Ramón y Cajal.|
|Hospital 12 de Octubre.|
|Hospital San Pedro de Alcántara.|
|Hospital Central de Asturias.|
|Hospital Clínico Universitario de Salamanca.|
|Hospital Virgen del Rocío|
|Hospital Clínico de Valencia.|
|Hospital Universitario La Fe.|