DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897507
• Other study ID #: AALL04B2
• Secondary ID: NCI-2009-00309CD
• Status: Completed
• Start date: May 13, 2004

Study information

• Verified date: October 2017
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment

Description:

PRIMARY OBJECTIVE:

I. To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952.

II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952.

III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data.

IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity.

OUTLINE:

Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL

Related Conditions & MeSH terms

• Childhood Acute Lymphoblastic Leukemia in Remission
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Childrens Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leukemia Relapse	Contingency tables will be used to tabulate the relationship between relapse and genotype, race, leukemia cytogenetics, day 7 bone marrow status, and treatment arm	Day 7
Primary	Development of veno-occlusive disease in patients on CCG-1952	Classification and Regression Trees (CART), genotype patterning, Multifactor Dimensionality Reduction (MDR) techniques will be used to identify SNP combinations associated with risk of relapse and VOD	Day 28
Primary	Development of a predictive model of leukemia relapse	Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response	Day 28
Primary	Development of a predictive model of leukemia toxicity	Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment toxicity.	Day 28
Secondary	Development of grade III/IV toxicity as defined by the CCG toxicity criteria	Contingency tables will be used to tabulate categorical toxicities and toxicity severity grade.	Day 28