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Clinical Trial DRUG AC220-007

Title
A Phase 3 Open-Label Randomized Study of Quizartinib (Ac220) Monotherapy versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-Line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation
Principal Investigator
Shira Dinner
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG AC220-007
Purpose
The purpose of this study is to evaluate the effectiveness of quizartinib when it is compared to standard forms of chemotherapy used in treating acute myeloid leukemia (AML).
Overview
This study is for patients who have AML and who also have an alteration (or mutation) to part of their genetic material that may worsen their prognosis. This mutation is known as FLT3-ITD. Quizartinib changes the activity of the mutation and this study is designed to evaluate its effectiveness when it is compared to standard forms of chemotherapy used in treating AML. In previous studies, some patients who received quizartinib had either complete or partial remission of their AML.
Eligibility
Some of the eligibility criteria include:
  • Participants must have AML that has either not responded to treatment or got worse after their initial treatment.
  • Participants must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants in this study will be randomly selected to receive either quizartinib or standard chemotherapy. Treatment will be divided into 28-day periods, called cycles. Participants assigned to quizartinib will take this study drug every day during the treatment cycles. This drug is taken orally (by mouth). Those assigned to standard chemotherapy will be given standard treatment as determined by the participant and the study doctor.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 21-Oct-14 10:11 PM

 

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