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

Biological Correlates With T-cell Acute Lymphoblastic Leukemia (T-ALL) Gene Expression and Clinical Outcome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01295476

Enrollment

135

Registered

2011-02-14

Start date

2011-04-30

Completion date

2013-05-31

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

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

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.

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.

Interventions

GENETICgene expression analysis

GENETICmicroarray analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 30 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Association between induction failure status predicted by 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026