Evaluating Cell Damage in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, or Fanconi Anemia; in Patients Who Were Exposed to Alkylating Agents; and in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00899795|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : December 4, 2017
RATIONALE: Studying samples of bone marrow from patients with cancer and from healthy volunteers in the laboratory may help doctors learn more about changes that occur in bone marrow stromal (connective tissue) cells. It may also help doctors understand the effects of alkylating agents on bone marrow stromal cells.
PURPOSE: This laboratory study is evaluating stromal cells in patients with acute myeloid leukemia, myelodysplastic syndromes, or Fanconi anemia; in patients who were exposed to alkylating agents; and in healthy volunteers.
|Condition or disease||Intervention/treatment|
|Leukemia Myelodysplastic Syndromes||Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization Other: flow cytometry Procedure: biopsy|
- Determine abnormal stromal function in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or Fanconi anemia; in patients who were exposed to alkylating agents; and in healthy volunteers.
- Determine whether clonal progenitors from patients with secondary AML or MDS are resistant to selected extracellular apoptotic cues.
- Determine whether stromal function in patients with secondary AML or MDS is more aberrant than stromal function in patients with primary AML or MDS.
- Determine whether cytotoxic agents known to induce secondary MDS or AML influence the supportive function of the bone marrow stroma.
- Determine whether cytoprotective agents reduce both cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells.
OUTLINE: Patients and healthy volunteers undergo bone marrow sample collection. Progenitor cells are grown in culture. Cell survival is quantified by flow cytometric and cytogenetic analysis, sister chromatid exchange, and FISH for chromosome 11 changes (for etoposide-exposed samples only).
PROJECTED ACCRUAL: A total of 24 patients and healthy volunteers will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||Stromal Injury and Clonal Adaptation in Myelodysplasia|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
- Abnormal stromal function
- Clonal progenitors resistant to selected extracellular apoptotic cells
- Comparison of stromal function between secondary vs primary acute myeloid leukemia or myelodysplastic syndromes
- Influence of cytotoxic agents on supportive function of the bone marrow stroma
- Reduction of cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells with use of cytoprotective agents
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): NCT00899795
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Grover C. Bagby, MD||OHSU Knight Cancer Institute|