Leukemia
Conditions
Keywords
childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute erythroleukemia (M6), childhood acute megakaryocytic leukemia (M7), childhood acute monoblastic leukemia (M5a), childhood acute monocytic leukemia (M5b), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myelomonocytic leukemia (M4), childhood acute minimally differentiated myeloid leukemia (M0)
Brief 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.
Interventions
OTHERlaboratory biomarker analysis
OTHERstudy of socioeconomic and demographic variables
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * Non-M3 AML * Cryopreserved bone marrow mononuclear cell specimens from patients enrolled on COG-AAML03P1 and COG-AAML0531 collected prior to cytarabine-based induction therapy * Patient samples from COG-AAML0531 must come from the control arm (i.e., no gemtuzumab ozogamicin induction therapy) PATIENT CHARACTERISTICS: * No Down syndrome PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of induction response prediction | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of complete response | — |
| Event-free survival and overall survival | — |
| Status (dead vs living) | — |
| Date of last follow up | — |
Outcome results
None listed