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
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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 |
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Leukemia | Genetic: gene expression analysis Genetic: microarray analysis Other: laboratory biomarker analysis |
OBJECTIVES:
- 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 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

- 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

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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 |
DISEASE CHARACTERISTICS:
- Newly diagnosed T-cell acute lymphoblastic leukemia
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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)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics

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
Principal Investigator: | Stuart S. Winter, MD | University of New Mexico Cancer Center |
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT01295476 |
Other Study ID Numbers: |
AALL10B1 COG-AALL10B1 CDR0000695252 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 |
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 |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |