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

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Children's Oncology Group

Study Description

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:

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 Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Childhood Acute Lymphoblastic Leukemia Acute Graft Versus Host Disease Adult T-cell Leukemia/lymphoma Lymphosarcoma

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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

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)

Investigators

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Principal Investigator:	Stuart S. Winter, MD	University of New Mexico Cancer Center

More Information

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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

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:

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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

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