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
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.
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Other: flow cytometry
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Stromal Injury and Clonal Adaptation in Myelodysplasia|
- Abnormal stromal function [ Designated as safety issue: No ]
- Clonal progenitors resistant to selected extracellular apoptotic cells [ Designated as safety issue: No ]
- Comparison of stromal function between secondary vs primary acute myeloid leukemia or myelodysplastic syndromes [ Designated as safety issue: No ]
- Influence of cytotoxic agents on supportive function of the bone marrow stroma [ Designated as safety issue: No ]
- Reduction of cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells with use of cytoprotective agents [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899795
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Grover C. Bagby, MD||OHSU Knight Cancer Institute|