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NCT01161550 · ClinicalTrials.gov registry record · Phase 1
Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01161550: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT01161550 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01161550, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study will evaluate the investigational drug Midostaurin in various doses given with ATRA and CLAG chemotherapy. Midostaurin is a FLT3 inhibitor that is activated or overexpressed in a significant proportion of AML patients. Research has shown that midostaurin and drugs like midostaurin may work better in combination with chemotherapy, like CLAG. CLAG is a combination of cladribine, cytarabine, and G-CSF which is approved by the FDA and used to treat AML.
Interventions
- DRUG Cladribine
- DRUG Cytarabine
- DRUG Midostaurin
- DRUG Granulocyte colony-stimulating factor (G-CSF)
- DRUG All-Trans Retinoic Acid (ATRA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01161550 record still lists
NCT01161550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which Cladribine is the first listed.
NCT01161550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01161550 about?
NCT01161550 is a clinical study titled "Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML". This study will evaluate the investigational drug Midostaurin in various doses given with ATRA and CLAG chemotherapy. Midostaurin is a FLT3 inhibitor that is activated or overexpressed in a significant proportion of AML patients. Research has shown that midostaurin and drugs like midostaurin may wor...
What is the current status of trial NCT01161550?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2010-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01161550?
The interventions under investigation include: Cladribine (DRUG), Cytarabine (DRUG), Midostaurin (DRUG), Granulocyte colony-stimulating factor (G-CSF) (DRUG), All-Trans Retinoic Acid (ATRA) (DRUG).
Who is sponsoring clinical trial NCT01161550?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01161550's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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