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

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00996047
First received: October 15, 2009
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization

Study Type: Observational
Official Title: S9007, Cytogenetic Studies in Leukemia Patients

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Maintain and expand a database of cytogenetic information on leukemia patients. [ Time Frame: While protocol was open ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Blood and bone marrow


Enrollment: 3341
Study Start Date: July 1991
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients registered to SWOG leukemia treatment protocols

Criteria

DISEASE CHARACTERISTICS:

  • Registered on one of the following Southwest Oncology Group treatment protocols:

    • SWOG-8326, SWOG-8600, SWOG-8612, SWOG-9034, SWOG-9108, OR any new leukemia protocol approved as of 1990

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996047

  Show 280 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Investigators
Study Chair: Elisabeth Paietta, PhD Our Lady of Mercy Medical Center Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Norwood TH, Gundacker HM, Slovak ML, et al.: Changes in the pattern of cytogenetic aberrations with advancing age in acute myeloid (Non-APL) leukemia: a Southwest Oncology study (S9007). [Abstract] Blood 108 (11): A-808, 2006.
Wolman SR, Gundacker HM, Slovak ML, et al.: Impact of trisomy 8(+8) on clinical presentation, treatment response, and survival in myeloid leukemia patients in Southwest Oncology Group (SWOG) trials. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1125, 282a, 2001.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00996047     History of Changes
Other Study ID Numbers: CDR0000078651, SWOG-9007, U10CA032102
Study First Received: October 15, 2009
Last Updated: January 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
untreated adult acute lymphoblastic leukemia
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
juvenile myelomonocytic leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Neoplasms
Leukemia
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on August 01, 2014