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
4 other identifiers
observational
18
1 country
1
Brief Summary
This research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells. It may also help doctors identify biomarkers related to cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 18, 2016
May 1, 2016
5.8 years
June 24, 2010
May 17, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Expression level and activation state of FLT3 protein, determined by Western blotting and FACS
Up to 4 months
TKI sensitivity, determined by MTT and annexin V assays
Up to 4 months
Baseline activation and inhibition of STAT5, AKT, and RAS-MAPK and other pathways, examined with Western blotting and phosphospecific antibodies
Baseline
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
Up to 4 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Samples from infants with leukemia
You may qualify if:
- Cryopreserved samples from infants with leukemia available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Monrovia, California, 91006-3776, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Brown, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2010
First Posted
June 25, 2010
Study Start
July 1, 2010
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 18, 2016
Record last verified: 2016-05