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Trial record 1 of 1 for:    CALGB 9862
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Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003861
First received: November 1, 1999
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Leukemia
Acute Lymphoblastic Leukemia
Acute Promyelocytic Leukemia
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Genetic Features of Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Association of novel genes or micorRNAs with other biomarkers [ Time Frame: At baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Clinical significance of MRD as defined by W T-1 [ Time Frame: At baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Tissue, Blood

Estimated Enrollment: 840
Study Start Date: April 1999
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (molecular genetic features)
Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.
Other: laboratory biomarker analysis

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients enrolled on CALGB-19802, any CALGB treatment trial, SWOG-S0521, or SWOG-S0535
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003861

  Show 51 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Wendy Stock, MD University of Chicago
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003861     History of Changes
Other Study ID Numbers: CALGB-9862  U10CA076001  CDR0000067025 
Study First Received: November 1, 1999
Last Updated: May 4, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
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 December 02, 2016