Collecting and Storing Blood, Bone Marrow, and Other Samples From Patients With Acute Leukemia, Chronic Leukemia, or Myelodysplastic Syndromes
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ClinicalTrials.gov Identifier: NCT00899223 |
Recruitment Status :
Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : January 24, 2019
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Condition or disease | Intervention/treatment |
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Acute Leukemia Chronic Leukemia Myelodysplasia | Other: biologic sample preservation procedure |
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 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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899223

Study Chair: | Michael Caligiuri, MD | Ohio State University Comprehensive Cancer Center |
Publications of Results:
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 Key Record Dates |
Last Update Posted: | January 24, 2019 |
Last Verified: | January 2019 |
Leukemia Preleukemia Myelodysplastic Syndromes Neoplasms by Histologic Type |
Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |