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Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
This study is currently recruiting participants.
Study NCT00003861   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: November 4, 2009   History of Changes

November 1, 1999
November 4, 2009
April 1999
 
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00003861 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
Molecular Genetic Features of Acute Lymphoblastic Leukemia

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.

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.

 
Interventional
Diagnostic
Leukemia
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: flow cytometry
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
450
 
 

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
Both
18 Years and older
No
 
United States
 
NCT00003861
 
CDR0000067025, CALGB-9862
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Wendy Stock, MD University of Chicago
National Cancer Institute (NCI)
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP