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NCT01419496 Clinical Trial

Study of Proteins in Promoting Chemotherapy Resistance in Samples From Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:
Identifying Stat3-Dependent Chemotherapy Resistance Pathways in Relapsed AML

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01419496
Other study ID # AAML12B1
Secondary ID COG-AAML12B1AAML
Status Completed
Phase N/A
First received August 17, 2011
Last updated May 17, 2016
Start date September 2011

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and development of drug resistance in patients.

PURPOSE: This research trial is studying proteins that may promote chemotherapy resistance in samples from patients with acute myeloid leukemia.

Description:

OBJECTIVES:

- Investigate whether changes in prosurvival signaling occur by comparing activation of the signal transducer and activator of transcription-3 (Stat3) and Stat5 pathways in paired diagnostic and relapse samples.

- Investigate changes in leukemia cell responses to extrinsic cues from the environment change, using a bone marrow stromal-cell co-culture model of chemotherapy resistance.

OUTLINE: Cryopreserved samples are analyzed for Stat3 and Stat5 expression by flow cytometry and in vitro chemotherapy sensitivity.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Years
Eligibility DISEASE CHARACTERISTICS:

- Paired diagnostic and relapsed cryopreserved samples from patients with acute myeloid leukemia

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• protein expression analysis

Other:
• flow cytometry

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Stat3 and Stat5 in paired diagnostic and relapsed AML samples No
Primary Reduction in chemotherapy sensitivity by relapsed samples compared to diagnostic samples No
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