Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate
Molecular Correlates of Methotrexate in Childhood ALL
5 other identifiers
observational
150
1 country
1
Brief Summary
This laboratory study is looking at response or resistance to chemotherapy in young patients with acute lymphoblastic leukemia treated with methotrexate. Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and drug resistance in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 11, 2016
May 1, 2016
12.5 years
May 9, 2009
May 9, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Molecular basis for human reduced folate carrier (hRFC) transcripts
Up to 4 years
Correlation of hRFC expression and methotrexate transport and sensitivities
Up to 4 years
High frequency gene/transcript variants for hRFC in relation to response and resistance to methotrexate
Up to 4 years
Multidrug resistance-associated proteins in relation to response and resistance to methotrexate and mercaptopurine
Up to 4 years
Study Arms (1)
Arm I
Tumor diagnostic specimens from patients who subsequently failed therapy within 4 years of diagnosis or who did not fail therapy within 4 years of diagnosis (control patients) are obtained from the Children's Oncology Group cellbank. Specimens are studied for molecular determinants of human reduced folate carrier (hRFC) gene expression and gene sequence alterations using reverse transcriptase-polymerase chain reaction (RT-PCR), thymidylate synthase inhibition assay, Rnase protection assay, or 5'RACE. Multidrug resistance proteins are also studied by RT-PCR.
Interventions
Eligibility Criteria
Newly Diagnosed Patients with ALL treated with Methotrexate
You may qualify if:
- Diagnosis of B-precursor or T-cell acute lymphoblastic leukemia
- Newly diagnosed disease subsequently treated with methotrexate
- Banked diagnostic blast specimens are available from Childrens Oncology Group (COG) cellbank
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Arcadia, California, 91006-3776, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Larry Matherly
Children's Oncology Group
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
November 1, 2003
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 11, 2016
Record last verified: 2016-05