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

Leukemia Clinical Trial

Official title:

Stromal Injury and Clonal Adaptation in Myelodysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899795
• Other study ID #: IRB00001025
• Secondary ID: P30CA069533OHSU-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 30, 2017
• Start date: June 2002
• Est. completion date: October 2010

Study information

• Verified date: November 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Genetic:
• cytogenetic analysis

• fluorescence in situ hybridization

Other:
• flow cytometry

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal stromal function
Secondary	Clonal progenitors resistant to selected extracellular apoptotic cells
Secondary	Comparison of stromal function between secondary vs primary acute myeloid leukemia or myelodysplastic syndromes
Secondary	Influence of cytotoxic agents on supportive function of the bone marrow stroma
Secondary	Reduction of cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells with use of cytoprotective agents