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Completed

NCT Number: NCT00899795

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.

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Key information

Age range

5 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cytogenetic analysis

Genetic

fluorescence in situ hybridization

Genetic

flow cytometry

Other

Biopsy

Procedure

Primary outcomes

  1. Abnormal stromal function

Secondary outcomes

  1. Clonal progenitors resistant to selected extracellular apoptotic cells

  2. Comparison of stromal function between secondary vs primary acute myeloid leukemia or myelodysplastic syndromes

  3. Influence of cytotoxic agents on supportive function of the bone marrow stroma

  4. Reduction of cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells with use of cytoprotective agents

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Stromal Injury and Clonal Adaptation in Myelodysplasia

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
May 12, 2009
Registry last updated
Dec 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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