RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic Factors in ALL & hENT1- dCK Expression as Prognostic Factors in AML

• Conditions: Acute Lymphoblastic Leukemia.; Acute Myeloblastic Leukemia

• Registration Number: NCT01307241
• Lead Sponsor: National Institute of Cancerología

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-02
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical responses in relation with SNP's or gene expression	clinical response.
To evaluate clinical response	December 2012	To evaluate clinical response after ending Hyper-CVAD schema for ALL patients. To evaluate clinical response \& DFS in relation with hENT1 \& dCK expression levels in AML patients.

Trial Locations

Locations (1)

Instituto Nacional de Cancerologia; 🇲🇽 Mexico city, DF, Mexico