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

• ClinicalTrials.gov Identifier: NCT00899223
• Recruitment Status: Active, not recruiting
• First Posted: May 12, 2009
• Last Update Posted: January 24, 2019
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

Study Description

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.

Condition or disease	Intervention/treatment
Acute Leukemia; Chronic Leukemia; Myelodysplasia	Other: biologic sample preservation procedure

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).

Study Design

• Study Type: Observational
• Estimated Enrollment: 1500 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: The CALGB Leukemia Tissue Bank
• Study Start Date: May 1996
• Estimated Primary Completion Date: December 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Other: biologic sample preservation procedure

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]

Biospecimen Retention:   Samples With DNA

• Bone Marrow Aspirate: 5 mL of bone marrow aspirate at the time of diagnosis, relapse, and during remission for each CALGB leukemia or myelodysplastic syndrome treatment protocol.
• Blood: 10 mL of whole blood at the time of diagnosis, relapse, and during remission for each CALGB leukemia or myelodysplastic syndrome treatment protocol.
• Buccal Cell Sample: One buccal cell sample at time of diagnosis, but may be obtained at other times if not done so previously

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with leukemia or myelodysplasia.

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

Contacts and Locations

  Show 142 Study Locations

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

• Study Chair: Michael Caligiuri, MD; Ohio State University Comprehensive Cancer Center

More Information

Publications of 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.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00899223 History of Changes
• Other Study ID Numbers: CALGB-9665; U10CA031946 ( U.S. NIH Grant/Contract ); CALGB-9665; CDR0000271412 ( Registry Identifier: NCI Physician Data Query )
• First Posted: May 12, 2009
• Last Update Posted: January 24, 2019
• Last Verified: January 2019

Additional relevant MeSH terms:

Leukemia; Preleukemia; Myelodysplastic Syndromes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions