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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01419496
First received: August 17, 2011
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Leukemia
Genetic: protein expression analysis
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Identifying Stat3-Dependent Chemotherapy Resistance Pathways in Relapsed AML

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Changes in Stat3 and Stat5 in paired diagnostic and relapsed AML samples [ Designated as safety issue: No ]
  • Reduction in chemotherapy sensitivity by relapsed samples compared to diagnostic samples [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2011
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute myeloid leukemia
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01419496

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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01419496     History of Changes
Other Study ID Numbers: AAML12B1  COG-AAML12B1  AAML12B1  NCI-2011-02984 
Study First Received: August 17, 2011
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
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)
adult acute myeloid leukemia with del(5q)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 23, 2016