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

Purpose

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.

Condition	Intervention
Leukemia	Other: laboratory biomarker analysis Other: study of socioeconomic and demographic variables


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Validation of a Classifier for Induction Response Prediction Using Single Cell Network Profiling (SCNP) Assays for Childhood AML

Resource links provided by NLM:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Leukemia

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Acute Myeloblastic Leukemia Without Maturation Acute Myeloblastic Leukemia With Maturation Acute Erythroid Leukemia Acute Megakaryoblastic Leukemia Acute Myelomonocytic Leukemia Di Guglielmo's Syndrome Acute Monoblastic Leukemia

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:

Accuracy of induction response prediction

Secondary Outcome Measures:

Duration of complete response
Event-free survival and overall survival
Status (dead vs living)
Date of last follow up

Biospecimen Retention: Samples With DNA

bone marrow


Estimated Enrollment:	97
Study Start Date:	March 2011
Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	up to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Diagnosis of acute myeloid leukemia.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321385

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Norman J. Lacayo, MD	Stanford University

More Information


Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT01321385 History of Changes
Other Study ID Numbers:	AAML11B8 COG-AAML11B8 ( Other Identifier: Children's Oncology Group ) NCI-2011-02851 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) AAML11B8 ( Other Identifier: Children's Oncology Group )
Study First Received:	March 22, 2011
Last Updated:	May 17, 2016

Keywords provided by Children's Oncology Group:


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)

Additional relevant MeSH terms:


Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms

ClinicalTrials.gov processed this record on August 17, 2017