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Stromal Injury and Clonal Adaptation in Myelodysplasia


N/A
5 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

Stromal Injury and Clonal Adaptation in Myelodysplasia


OBJECTIVES:

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Abnormal stromal function

Safety Issue:

No

Principal Investigator

Grover C. Bagby, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445436

NCT ID:

NCT00899795

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • 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)
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • untreated adult acute myeloid leukemia
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
OHSU Knight Cancer Institute Portland, Oregon  97239