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

Brief Title

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

Official Title

Molecular Genetic Features of Acute Leukemia

Brief Summary

      This research trial studies molecular genetic features in blood and tissue samples from
      patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia.
      Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute
      promyelocytic leukemia in the laboratory may help doctors identify and learn more about
      biomarkers related to cancer.
    

Detailed Description

      Objectives:

        1. To perform quantitative PCR using known leukemia specific markers in diagnostic bone
           marrow specimens of patients with newly diagnosed APL and ALL and to correlative
           pre-treatment copy number with other biologic and molecular features, clinical response,
           and treatment outcome.

        2. To evaluate the expression of novel genes or microRNAs implicated in disease
           pathogenesis and treatment response in pretreatment blood and bone marrow specimens of
           patients with APL and ALL and to correlate expression level with other biological
           features and treatment outcome.

        3. To evaluate the clinical significance of sequential quantitative MRD measurements using
           real-time quantitative PCR and/or flow cytometry during and following treatment of ALL
           and APL and correlate these findings with efficacy of novel treatment approaches and
           with other biological and clinical prognostic features.

        4. To compare measurement of MRD in blood with bone marrow specimens in sequential
           remission specimens of patients receiving treatment on ALL and APL treatment trials.
    

Study Type

Observational

Primary Outcome

Disease-free survival

Secondary Outcome

 Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL

Condition

Leukemia

Intervention

laboratory biomarker analysis

Study Arms / Comparison Groups

 Ancillary-Correlative (molecular genetic features)

Description:  Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.

Publications

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

Recruitment Status

Other

Estimated Enrollment

840

Start Date

April 1999

Primary Completion Date

January 2100

Eligibility Criteria

        -  Patients with a diagnosis of acute lymphoblastic leukemia (ALL) entered onto CALGB
             treatment trials for previously untreated ALL must be enrolled on CALGB 9862. Entry on
             CALGB 8461 is strongly encouraged.

          -  Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521
             or S0535 must be enrolled on CALGB 9862.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Wendy Stock, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00003861

Organization ID

CALGB-9862

Secondary IDs

U10CA076001

Responsible Party

Sponsor

Study Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Wendy Stock, MD, Study Chair, University of Chicago

Verification Date

August 2021