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

NCT00899795 | Completed DMC

• 4 other identifiers: IRB00001025P30CA069533OHSU-HEM-02008-LXCDR0000445436
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Abnormal stromal function

Secondary Outcomes (4)

• 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

Interventions

cytogenetic analysis GENETIC

fluorescence in situ hybridization GENETIC

flow cytometry OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 5 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient, outpatient, and normal volunteers

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Congenital Abnormalities; Leukemia, Myeloid, Acute

Interventions

Cytogenetic Analysis; In Situ Hybridization, Fluorescence; Flow Cytometry; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Histological Techniques; Nucleic Acid Hybridization; Cell Separation; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Grover C. Bagby, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: June 1, 2002
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 4, 2017

Record last verified: 2017-11

Locations

US (1)