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Diagnostic Study of Patients With Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2008

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003861
  Purpose

RATIONALE: Determination of genetic markers for acute lymphoblastic 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.


Condition Intervention
Leukemia
Procedure: reverse transcriptase-polymerase chain reaction

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

U.S. FDA Resources

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

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

Estimated Enrollment:   300
Study Start Date:   April 1999

Detailed Description:

OBJECTIVES:

  • Evaluate, using reverse transcriptase-polymerase chain reaction (RT-PCR), the clinical significance of p190 and p210 BCR-ABL fusion transcripts measured at the time of diagnosis in patients with acute lymphoblastic leukemia (ALL).
  • Evaluate, using quantitative and qualitative RT-PCR, the clinical significance of minimal residual disease as defined by BCR-ABL fusion transcripts in patients who have achieved complete remission.
  • Compare blood with bone marrow samples for the detection and quantitation of BCR-ABL transcripts in diagnosis and sequential remission samples.
  • Determine the impact of the expression of WT-1 at diagnosis, remission, and relapse in BCR-ABL positive and negative ALL on clinical outcome.

OUTLINE: Blood and bone marrow are collected from patients before therapy; after courses 1, 3, and 6; every 6 months during maintenance therapy; 1 year after therapy completion; and at relapse.

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.

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 300 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 acute lymphoblastic leukemia and entered on CALGB-19802 or its successor

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 68 study locations  Show 68 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


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

Study ID Numbers:   CDR0000067025, CALGB-9862
First Received:   November 1, 1999
Last Updated:   October 8, 2008
ClinicalTrials.gov Identifier:   NCT00003861
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma
Acute lymphoblastic leukemia, adult

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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