This trial is active, not recruiting.

Conditions acute lymphoblastic leukemia., acute myeloblastic leukemia
Sponsor National Institute of Cancerología
Start date December 2010
End date December 2014
Trial size 50 participants
Trial identifier NCT01307241, 010/020/ICI


Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical & molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate analysis will be done to evaluate factors influencing on response and survival.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico.

Primary Outcomes

To evaluate clinical response
time frame: December 2012
Clinical responses in relation with SNP's or gene expression
time frame: clinical response.

Eligibility Criteria

Male or female participants at least 15 years old.

Inclusion Criteria: - Age: older than 15 years. - Male, female. - Normal renal & liver functions. - Without previous treatment. - Candidate to be treated with hyperCVAD Schema (ALL patients). - Candidate to receive induction remission with cytarabine (AML patients) Exclusion Criteria: - Patients not candidate to receive methotrexate or cytarabine.

Additional Information

Official title Evaluation of RFC Transporter & MTHFR SNP's, as Well as hEN1 and DCK Expression as Prognostic Factors in Patients With Acute Lymphoblastic Leukemia.
Principal investigator myrna candelaria, md
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Institute of Cancerología.