DHPLC Determination of TPMT Polymorphisms.

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00402090
• Other study ID #: 005/007/ICI
• Secondary ID: CONACYT: Salud-2
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2006
• Last updated: November 17, 2006
• Start date: April 2005
• Est. completion date: November 2006

Study information

• Verified date: November 2006
• Source: National Institute of Cancerología
• Contact: Myrna Candelaria, MD
• Phone: (52)55-56280479
• Email: myrnac[@]prodigy.net.mx
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.

Description:

Objectives: Determine by DHPLC analysis the frequency of TPMT polymorphisms in mestizos mexican population with acute lymphoblastic leukemia.

• To do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity.

• Inclusion criteria: Healthy volunteers or patients with acute lymphoblastic leukemia, age > 18 years, who attend to the National Institute of Cancerologia.

• Exclussion criteria: Patients with ALL, who are unable to have an adequate follow-up.

• Samples: Genomic DNA from peripheral blood leukocytes was isolated by standard methods. Known (wild-type and polymorphic) sequenced polymerase chain reaction (PCR) fragments of the TPMT gene were used as controls. TPMT gene fragments were amplified. PCR products were then analyzed by denaturating high performance liquid chromatography (DHPLC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy and patientes with acute lymphoblastic leukemia.

• Age: older than 18 years.

• Attend to the National Institute of Cancerologia

Exclusion Criteria:

• Foreign patients with an irregular attendance to the National Institute of Cancerologia

Study Design

Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Mexico	National Institute of Cancerologia	MExico city	DF

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cancerología

Country where clinical trial is conducted

Mexico,