Biomarker Study in Bone Marrow Samples From Patients With T-Cell Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01295476
First received: February 11, 2011
Last updated: May 16, 2016
Last verified: May 2016
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Purpose
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 | Intervention |
|---|---|
|
Leukemia |
Genetic: gene expression analysis Genetic: microarray analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Biological Correlates With T-cell Acute Lymphoblastic Leukemia (T-ALL) Gene Expression and Clinical Outcome |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia
Lymphosarcoma
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Association between induction failure status predicted by 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434 [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Bone Marrow
| Estimated Enrollment: | 135 |
| Study Start Date: | April 2011 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 30 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Newly diagnosed T-cell acute lymphoblastic leukemia
Criteria
DISEASE CHARACTERISTICS:
- 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)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
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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: NCT01295476
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295476
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Stuart S. Winter, MD | University of New Mexico Cancer Center |
More Information
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01295476 History of Changes |
| Other Study ID Numbers: | AALL10B1 COG-AALL10B1 CDR0000695252 AALL10B1 NCI-2011-02848 |
| Study First Received: | February 11, 2011 |
| Last Updated: | May 16, 2016 |
| Health Authority: | United States: Federal Government |
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:
|
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 |
ClinicalTrials.gov processed this record on September 27, 2016