Clinical Trial DRUG AC220-007
- 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
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG AC220-007
- 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).
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Shira Dinner
- The ROCKET Study: A Phase 2, Single-arm, Multicenter Trial to Determine the Efficacy and Safety of JCAR015 in Adult Subjects with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
- A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults
last updated: 25-May-16 08:02 AM
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