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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 : July 20, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date July 20, 2021
Actual Study Start Date May 1996
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2016)
  • 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 ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Blood, Bone Marrow, and Other Samples From Patients With Acute Leukemia, Chronic Leukemia, or Myelodysplastic Syndromes
Official Title The CALGB Leukemia Tissue Bank
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).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • 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
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with leukemia or myelodysplasia.
Condition
  • Acute Leukemia
  • Chronic Leukemia
  • Myelodysplasia
Intervention Other: biologic sample preservation procedure
Study Groups/Cohorts 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.
Intervention: Other: biologic sample preservation procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 4, 2016)
1500
Original Enrollment Not Provided
Study Completion Date Not Provided
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00899223
Other Study ID Numbers CALGB-9665
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-9665
CDR0000271412 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Michael Caligiuri, MD Ohio State University Comprehensive Cancer Center
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2021