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Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003861
First received: November 1, 1999
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

RATIONALE: Determination of genetic markers for acute lymphoblastic leukemia and acute promyelocytic leukemia may help identify patients with this disease and help predict the outcome of treatment.

PURPOSE: Diagnostic study of genetic markers in adult patients who have acute lymphoblastic leukemia or acute promyelocytic leukemia.


Condition Intervention
Leukemia
 Genetic: reverse transcriptase-polymerase chain reaction
Other: flow cytometry

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Molecular Genetic Features of Acute Lymphoblastic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of novel genes or micorRNAs with other biomarkers [ Designated as safety issue: No ]
  • Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL [ Designated as safety issue: No ]
  • Clinical significance of MRD as defined by W T-1 [ Designated as safety issue: No ]
  • Blood and bone marrow specimen comparison on the quantitative measurement of MRD [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: April 1999
Detailed Description:

OBJECTIVES:

  • Perform quantitative polymerase chain reaction (PCR) using known leukemia specific markers in diagnostic bone marrow specimens and correlate pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcomes of patients with previously untreated acute lymphoblastic leukemia (ALL) or acute promyelocytic leukemia (APL).
  • Evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of these patients and correlate these findings with other biological features and treatment outcome.
  • Evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment and correlate these findings with efficacy of novel treatment approaches and other biological and clinical prognostic features.
  • Compare the measurement of MRD in blood with bone marrow specimens in sequential remission specimens.

OUTLINE: Blood and bone marrow samples are collected from patients periodically.

Samples are examined for the p190 and p210 BCR-ABL and WT-1 transcripts using reverse transcriptase-polymerase chain reaction (RT-PCR) analysis of the DNA and for marginal residual disease (MRD) via flow cytometric analysis.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study over 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following diseases:

    • Acute lymphoblastic leukemia (ALL)

      • Patients enrolled on CALGB-19802 or any CALGB treatment trials for previously untreated ALL, must be enrolled on this trial

    • Acute promyelocytic leukemia (APL)

      • Patients enrolled on SWOG-S0521 or SWOG-S0535 for previously untreated APL must be enrolled on this trial

PATIENT CHARACTERISTICS:

Age:

  • Adult

Performance status:

  • See Disease Characteristics

Life expectancy:

  • See Disease Characteristics

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • See Disease Characteristics

Renal:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003861

  Show 51 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: Wendy Stock, MD University of Chicago
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00003861     History of Changes
Other Study ID Numbers: CDR0000067025, CALGB-9862
Study First Received: November 1, 1999
Last Updated: February 19, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated adult acute lymphoblastic leukemia
adult acute promyelocytic leukemia (M3)

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid, Acute
Leukemia, Myeloid

ClinicalTrials.gov processed this record on May 19, 2013