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Biomarker Study in Bone Marrow Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT01295476
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : May 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Studying samples of 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. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with T-cell acute lymphoblastic leukemia.

Condition or disease Intervention/treatment
Leukemia Genetic: gene expression analysis Genetic: microarray analysis Other: laboratory biomarker analysis

Detailed Description:


  • To confirm an association between induction failure (IF) status predicted by a previously identified 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434.
  • To explore whether there is an association between early relapse (as defined by bone marrow or extramedullary relapse within 18 months of diagnosis) predicted by previously identified 5-member (primary) and 57-member (secondary) genomic classifiers, and actual relapse status at 18 months on COG study AALL0434. (Exploratory)

OUTLINE: RNA from cryopreserved bone marrow samples are analyzed for gene expression by microarray methods. Samples are then compared with the 116-member genomic classifier.

Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biological Correlates With T-cell Acute Lymphoblastic Leukemia (T-ALL) Gene Expression and Clinical Outcome
Study Start Date : April 2011
Primary Completion Date : May 2013
Study Completion Date : May 2013

Primary Outcome Measures :
  1. Association between induction failure status predicted by 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434

Biospecimen Retention:   Samples With DNA
Bone Marrow

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed T-cell acute lymphoblastic leukemia


  • Newly diagnosed T-cell acute lymphoblastic leukemia
  • Cryopreserved bone marrow from the Children Oncology Group (COG) Cell Bank of patients enrolled on COG-AALL03B1 and COG-AALL0434, including the following:

    • 30 samples from patients who had > 25% bone marrow blasts at day 29 (induction failure [IF] cases)
    • Samples of cases of bone marrow and/or CNS relapse occurring within the first 18 months of treatment
    • Random samples of 105 non-IF cases who achieved remission at the end of induction therapy (at least 18 months)


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295476

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Stuart S. Winter, MD University of New Mexico Cancer Center

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01295476     History of Changes
Other Study ID Numbers: AALL10B1
AALL10B1 ( Other Identifier: COG )
NCI-2011-02848 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases