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

Sponsor
National Institute of Cancerología (Other)
Overall Status
Unknown status
CT.gov ID
NCT01307241
Collaborator
(none)
50
Enrollment
1
Location
60
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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.
    Study Start Date :
    Dec 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2014
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    one cohort

    Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Clinical responses in relation with SNP's or gene expression [clinical response.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Nacional de Cancerologia Mexico city DF Mexico 14080

    Sponsors and Collaborators

    • National Institute of Cancerología

    Investigators

    • Principal Investigator: myrna candelaria, md, Instituto Nacional de Cancerología Mexico

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DR. MYRNA CANDELARIA, Clinical researcher., National Institute of Cancerología
    ClinicalTrials.gov Identifier:
    NCT01307241
    Other Study ID Numbers:
    • 010/020/ICI
    First Posted:
    Mar 2, 2011
    Last Update Posted:
    Nov 15, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by DR. MYRNA CANDELARIA, Clinical researcher., National Institute of Cancerología
    Acute lymphoblastic leukemia
    prognostic factor
    pharmacogenetics.
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Nov 15, 2013