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

Identifying Stat3-Dependent Chemotherapy Resistance Pathways in Relapsed AML

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.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Genetic: protein expression analysis; Other: laboratory biomarker analysis; Other: flow cytometry

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myeloid leukemia

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in Stat3 and Stat5 in paired diagnostic and relapsed AML samples
Reduction in chemotherapy sensitivity by relapsed samples compared to diagnostic samples

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michele S. Redell, MD, PhD, Texas Children's Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 17, 2011
• First Submitted That Met QC Criteria: August 17, 2011
• First Posted (Estimate): August 18, 2011

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• 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); recurrent adult acute myeloid leukemia; recurrent childhood acute myeloid leukemia; adult acute myeloid leukemia with del(5q)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: AAML12B1 (Other Identifier: Children's Oncology Group); COG-AAML12B1 (Other Identifier: Children's Oncology Group); NCI-2011-02984 (Registry Identifier: CTRP (Clinical Trial Reporting Program))