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CompletedNCT01419496Updated May 18, 2016

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

An observational study in Leukemia, sponsored by Children's Oncology Group. Completed. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
40
Ages
Up to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia

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Keywords

  • 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)
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 40 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute myeloid leukemia

Eligibility criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • Geneticprotein expression analysis
  • Otherflow cytometry
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Changes in Stat3 and Stat5 in paired diagnostic and relapsed AML samples

  2. Reduction in chemotherapy sensitivity by relapsed samples compared to diagnostic samples

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01419496
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 18, 2011
Start date
Sep 2011
Primary completion
May 2016
Last update
May 18, 2016

Study contacts

Michele S. Redell, MD, PhD
principal investigator · Texas Children's Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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