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Studying Dexamethasone and Prednisone Sensitivity in Samples From Younger Patients With High-Risk B-Cell Precursor Acute Lymphoblastic Leukemia

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: March 10, 2012
Last updated: May 17, 2016
Last verified: May 2016

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.

Condition Intervention
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: B-precursor Acute Lymphoblastic Leukemia (ALL): Studying the Mechanisms Behind Dexamethasone and Prednisone Sensitivity in High-Risk Patients

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old [ Designated as safety issue: No ]
  • Genes that are required for efficient apoptosis [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2012
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9.
  • Identify differences in gene expression and GR occupancy of response elements in HR BCP-ALL patients > 10 years old in response to both Dex and Pred.

OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene expression and ChiPseq data sets are compared by luciferase reporter assay.


Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia


  • Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia
  • Samples from patients treated and not treated with Dex and Pred


  • Not specified


  • 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 identifier: NCT01553162

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Miles A. Pufall, PhD University of Iowa
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01553162     History of Changes
Other Study ID Numbers: AALL12B4  COG-AALL12B4  CDR0000728515  AALL12B4  NCI-2012-00704 
Study First Received: March 10, 2012
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016