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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295476
• Other study ID #: AALL10B1
• Secondary ID: COG-AALL10B1CDR0
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: May 16, 2016
• Start date: April 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 30 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Genetic:
• gene expression analysis

• microarray analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between induction failure status predicted by 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database