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

Acute Myeloblastic Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01307241
• Other study ID #: 010/020/ICI
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2011
• Last updated: November 14, 2013
• Start date: December 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2013
• Source: National Institute of Cancerología
• Contact: n/a
• Is FDA regulated: No
• Health authority: MEXICO: Federal Comission to protect sanitary risks. Healthy Ministerium
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia.
• Acute Myeloblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerologia	Mexico city	DF

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cancerología

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate clinical response	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.	December 2012	No
Primary	Clinical responses in relation with SNP's or gene expression		clinical response.	No