Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
DR. MYRNA CANDELARIA, National Institute of Cancerología Identifier:
First received: February 28, 2011
Last updated: November 14, 2013
Last verified: November 2013

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.

Acute Lymphoblastic Leukemia.
Acute Myeloblastic Leukemia

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by National Institute of Cancerología:

Primary Outcome Measures:
  • To evaluate clinical response [ Time Frame: December 2012 ] [ Designated as safety issue: No ]
    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.

  • Clinical responses in relation with SNP's or gene expression [ Time Frame: clinical response. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples.

Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
one cohort
Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico.


Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute lymphoblastic leukemia


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.
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Please refer to this study by its identifier: NCT01307241

Instituto Nacional de Cancerologia
Mexico city, DF, Mexico, 14080
Sponsors and Collaborators
National Institute of Cancerología
Principal Investigator: myrna candelaria, md Instituto Nacional de Cancerología Mexico
  More Information

No publications provided

Responsible Party: DR. MYRNA CANDELARIA, Clinical researcher., National Institute of Cancerología Identifier: NCT01307241     History of Changes
Other Study ID Numbers: 010/020/ICI
Study First Received: February 28, 2011
Last Updated: November 14, 2013
Health Authority: MEXICO: Federal Comission to protect sanitary risks. Healthy Ministerium

Keywords provided by National Institute of Cancerología:
Acute lymphoblastic leukemia
prognostic factor

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, Myeloid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on February 27, 2015