Collecting and Storing Blood, Bone Marrow, and Other Samples From Patients With Acute Leukemia, Chronic Leukemia, or Myelodysplastic Syndromes

Brief Summary

Official Title: “The CALGB Leukemia Tissue Bank”

As one of the nation's largest cooperative cancer treatment groups, the Alliance for Clinical Trials in Oncology (Alliance) is in a unique position to organize a Leukemia Tissue Bank. The member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome each year, and uniformly treat these patients with chemotherapy regimens. The Alliance offers centralized data management for the clinical history, the classification of the leukemia and myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up. The highly skilled health care providers at each member institution are familiar with obtaining informed consent, completing data questionnaires and shipping specimens. There currently exists a central processing facility where samples are prepared for a variety of cellular and molecular studies. Hence, the patient resources, the health care providers, and a processing facility for a Leukemia Tissue Bank are all in place. What is needed, however, and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood and normal tissue from patients with hematologic malignancies who are to be enrolled on Alliance (Cancer and Leukemia Group B [CALGB]) treatment studies.

  • Study Type: Observational
  • Study Design: Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

Detailed Clinical Trial Description

The objective of the study is to collect and store specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome (MDS) who are entered on a CALGB protocol for previously untreated patients. Bone marrow aspirate and blood specimens are obtained from patients at diagnosis, remission, or relapse and stored. Buccal smears are obtained at diagnosis, and DNA is extracted and preserved.

It was anticipated that the specimens collected under this protocol would be used by a large number of investigators. This protocol does not describe the details of each approved project (eg, eligibility age range).

Interventions Used in this Clinical Trial

  • Other: biologic sample preservation procedure

Arms, Groups and Cohorts in this Clinical Trial

  • Group 1
    • Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.

Outcome Measures for this Clinical Trial

Primary Measures

  • Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol
    • Time Frame: At diagnosis
      Safety Issue?: No
  • Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol
    • Time Frame: At relapse
      Safety Issue?: No
  • Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol
    • Time Frame: At remission
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.
  • Signed informed consent
  • Gender Eligibility for this Clinical Trial: Both

    Minimum Age for this Clinical Trial: N/A

    Maximum Age for this Clinical Trial: N/A

    Are Healthy Volunteers Accepted for this Clinical Trial: No

    Clinical Trial Investigator Information

    • Lead Sponsor
      • Alliance for Clinical Trials in Oncology
    • Collaborator
      • National Cancer Institute (NCI)
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Michael Caligiuri, MD, Study Chair, Ohio State University Comprehensive Cancer Center

    Citations Reporting on Results

    Liu TH, Raval A, Chen SS, Matkovic JJ, Byrd JC, Plass C. CpG island methylation and expression of the secreted frizzled-related protein gene family in chronic lymphocytic leukemia. Cancer Res. 2006 Jan 15;66(2):653-8.

    Source

    Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

    The URL of this page is:
    http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00899223