NCT01321385

Biomarkers in Predicting Response to Treatment in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

Validation of a Classifier for Induction Response Prediction Using Single Cell Network Profiling (SCNP) Assays for Childhood AML

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 97 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. PURPOSE: This research trial is studying biomarkers in predicting response to treatment in bone marrow samples from young patients with acute myeloid leukemia.

Detailed description

OBJECTIVES: Primary * To validate the accuracy of a pre-specified acute myeloid leukemia (AML) induction response classifier or the My Profile™ AML Induction Therapy Assay (run in a Good Laboratory Practice \[GLP\] laboratory using Good Manufacturing Practice \[GMP\] reagents) in predicting response to cytarabine-based induction chemotherapy in pediatric patients with non-M3 AML. Secondary * To validate the continuous score from the pre-specified induction response classifier as a predictor of response to induction chemotherapy, after controlling for the simultaneous effects of clinical variables at base-line and/or pre-induction therapy (e.g., age, WBC, and percentage \[%\] of blasts), and tests commonly available after the start of induction therapy (e.g., cytogenetics and molecular markers). * To validate the accuracy of the pre-specified induction response classifier as a binary predictor of induction response using a pre-specified cutpoint to assign patients to no response (NR) or complete response (CR) groups. * To validate the accuracy of the pre-specified induction response classifier as a binary predictor of induction response using a pre-specified cutpoint to assign patients to NR or CR groups, after controlling for the simultaneous effects of clinical variables at base-line (pre-induction therapy) (e.g., age, WBC, % blasts) and clinical variables, including tests commonly available after start of induction therapy (e.g., age, WBC, cytogenetics). OUTLINE: Cryopreserved bone marrow mononuclear cell specimens are analyzed by cell networking profiling assays. Results are then compared with patient outcomes and demographics from COG-AAML03P1 and COG-AAML0531 studies. Molecular markers analyzed include Flt3ITD, NPM1, CEBPA, and MRA.

Conditions

• Leukemia

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
OTHER	study of socioeconomic and demographic variables

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-05-01
• First posted: 2011-03-23
• Last updated: 2016-05-18