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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 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 11 participants.

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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

FieldValue
Enrollment Target 11 participants
Start Date 2010-11
Est. Completion 2012-08
Phase Phase 1

What the Registry Record Tells You About NCT01161550

The ClinicalTrials.gov registry entry for NCT01161550 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Cladribine is the first listed.

NCT01161550 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.