Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	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 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:	Diagnostic
Official Title:	Molecular Genetic Features of Acute Lymphoblastic Leukemia

Resource links provided by NLM:

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

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 67 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

Study ID Numbers:	CDR0000067025, CALGB-9862
Study First Received:	November 1, 1999
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00003861 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

untreated adult acute lymphoblastic leukemia
adult acute promyelocytic leukemia (M3)

Additional relevant MeSH terms:

Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders
Neoplasms by Histologic Type

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Leukemia, Promyelocytic, Acute
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 27, 2009