- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01150669
Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia
SCOR in Targeted Therapies for Infant Leukemia Project 3: Targeting FLT3 in Infant Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia.
II. Determine whether FLT3 protein expression level and/or activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia.
III. Determine whether lestaurtinib activates STAT5, AKT, and RAS-MAPK and other pathways.
IV. Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells.
OUTLINE: This is a multicenter study.
Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot. The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cryopreserved samples from infants with leukemia available
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational
Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents.
Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot.
The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model.
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Samples are analyzed in laboratory studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Expression level and activation state of FLT3 protein, determined by Western blotting and FACS
Time Frame: Up to 4 months
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Up to 4 months
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TKI sensitivity, determined by MTT and annexin V assays
Time Frame: Up to 4 months
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Up to 4 months
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Baseline activation and inhibition of STAT5, AKT, and RAS-MAPK and other pathways, examined with Western blotting and phosphospecific antibodies
Time Frame: Baseline
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Baseline
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Incidence of cell death in primary infant leukemia samples treated with sequenced combinations of chemotherapy and FLT3 TKI using MTT and annexin V binding assays and median effect analysis
Time Frame: Up to 4 months
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Up to 4 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick Brown, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAML10B18
- NCI-2011-02240 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- COG-AAML10B18 (Other Identifier: Children's Oncology Group)
- CDR0000675724 (Other Identifier: Clinical Trials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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