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

NCT01307241 | Unknown

• 1 other identifier: 010/020/ICI
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia.; Acute Myeloblastic Leukemia

Keywords

Acute lymphoblastic leukemia; prognostic factor; pharmacogenetics.

Outcome Measures

Primary Outcomes (2)

• 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

• Clinical responses in relation with SNP's or gene expression

  clinical response.

Study Arms (1)

one cohort

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute lymphoblastic leukemia

You may qualify if:

• 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)

You may not qualify if:

• Patients not candidate to receive methotrexate or cytarabine.

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Officials

• myrna candelaria, md

  Instituto Nacional de Cancerología Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical researcher.

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 2, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

ME (1)