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
NCT ID: NCT00899795
Last Updated: 2017-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2002-06-30
2010-10-31
Brief Summary
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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.
Detailed Description
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Primary
* 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.
Secondary
* 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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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cytogenetic analysis
fluorescence in situ hybridization
flow cytometry
biopsy
Eligibility Criteria
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Inclusion Criteria
* Meets 1 of the following criteria:
* Diagnosis of acute myeloid leukemia or myelodysplastic syndromes and requires bone marrow aspiration/biopsy for clinical purposes
* Primary or secondary disease
* Diagnosis of Fanconi anemia by positive mitomycin C test (age 5 to 55 years)
* Received prior chemotherapy containing any of the following alkylating agents: mechlorethamine, chlorambucil, cyclophosphamide, melphalan, busulfan, or topoisomerase inhibitors
* Healthy volunteer (age 18 and over), meeting the following criteria:
* CBC normal
* WBC \> 1,000/mm³
* Hemoglobin \> 10 g/dL
* Platelet count \> 70,000/mm³
* No bone marrow metastases
* No evidence of non-hematopoietic malignancy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* No clinical signs and symptoms of acute or subacute infection (viral, bacterial, or fungal infection)
* No allergy to lidocaine or xylocaine
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 6 months since prior cytotoxic or immunosuppressive agents
* No prior extensive pelvic radiotherapy (\> 20 Gy)
5 Years
120 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Grover Bagby
Professor Emeritus
Principal Investigators
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Grover C. Bagby, MD
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, United States
Countries
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Other Identifiers
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OHSU-HEM-02008-LX
Identifier Type: -
Identifier Source: secondary_id
CDR0000445436
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00001025
Identifier Type: -
Identifier Source: org_study_id