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

The CALGB Leukemia Tissue Bank

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00899223
Enrollment
1500
Registered
2009-05-12
Start date
1996-05-31
Completion date
Unknown
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Chronic Leukemia, Myelodysplasia

Brief summary

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.

Detailed 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

OTHERbiologic sample preservation procedure

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocolAt diagnosis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026