S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

• Registration Number: NCT00996047
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at bone marrow and blood samples from patients with leukemia or other hematopoietic cancers.

Detailed Description

Primary objective:

\* Maintain and expand a database of cytogenetic information on leukemia patients.

Other objectives as funding permits:

* Determine the frequency and prognostic significance of cytogenetic abnormalities in bone marrow or peripheral blood cells in patients with leukemia prior to treatment and at various times during treatment undergoing treatment on a companion clinical trial.

* Correlate the presence of cytogenetic features with clinical, pathophysiological, cellular, and molecular characteristics in these patients.

* Provide quality control for all Southwest Oncology Group cytogenetic data.

OUTLINE: Bone marrow and/or peripheral blood samples from patients on specific treatment protocols for leukemia are analyzed for cytogenetic abnormalities. Samples from patients with chronic lymphocytic leukemia (CLL) are analyzed for trisomy 12 by fluorescence in situ hybridization and conventional cytogenetics.

PROJECTED ACCRUAL: Approximately 2,500 patients (1,200 with first-line acute myeloid leukemia \[AML\], 500 with first-line acute lymphoblastic leukemia \[ALL\], 200 with relapsed AML, 125 with chronic phase chronic myelogenous leukemia \[CML\], 100 with accelerated phase or blastic phase CML, 250 with hairy cell leukemia, and 125 with relapsed ALL or CLL) will be accrued for this study within 5 years.

Study Timeline

• Study Start: 1991-07
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3341

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maintain and expand a database of cytogenetic information on leukemia patients.	While protocol was open

Trial Locations

Locations (280)

Providence Cancer Center at Providence Hospital; 🇺🇸 Mobile, Alabama, United States

Providence Cancer Center; 🇺🇸 Anchorage, Alaska, United States

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center; 🇺🇸 Ft. Smith, Arkansas, United States

Alta Bates Summit Comprehensive Cancer Center; 🇺🇸 Berkeley, California, United States

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center; 🇺🇸 Burbank, California, United States

Peninsula Medical Center; 🇺🇸 Burlingame, California, United States

Tibotec Therapeutics - Division of Ortho Biotech Products, LP; 🇺🇸 Marysville, California, United States

Sutter Health - Western Division Cancer Research Group; 🇺🇸 Novato, California, United States

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States

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