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


N/A
1 Year
30 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Stuart S. Winter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000695252

NCT ID:

NCT01295476

Start Date:

April 2011

Completion Date:

Related Keywords:

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

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