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

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ClinicalTrials.gov Identifier: NCT01307241
Recruitment Status : Unknown
Verified November 2013 by DR. MYRNA CANDELARIA, National Institute of Cancerología.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2011
Last Update Posted : November 15, 2013
Information provided by (Responsible Party):
DR. MYRNA CANDELARIA, 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.

Condition or disease
Acute Lymphoblastic Leukemia. Acute Myeloblastic Leukemia

Study Type : Observational
Estimated 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 : December 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

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

Primary Outcome Measures :
  1. 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.

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

Biospecimen Retention:   Samples With DNA
Blood samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: DR. MYRNA CANDELARIA, Clinical researcher., National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT01307241     History of Changes
Other Study ID Numbers: 010/020/ICI
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

Keywords provided by DR. MYRNA CANDELARIA, National Institute of Cancerología:
Acute lymphoblastic leukemia
prognostic factor

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid