Evaluation of RFC Transporter & MTHFR SNP's, as Well as hEN1 and DCK Expression as Prognostic Factors in Patients With Acute Lymphoblastic Leukemia.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Clinical responses in relation with SNP's or gene expression
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Clinical responses in relation with SNP's or gene expression
Time Frame: clinical response.
To evaluate clinical response
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
DR. MYRNA CANDELARIA
Clinical researcher.
National Institute of Cancerología