A Phase 3 Open-Label Randomized Study of Quizartinib (AC220)
Research type
Research Study
Full 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 Transplant (HSCT) Consolidation.
IRAS ID
149751
Contact name
Nigel Russell
Contact email
Sponsor organisation
Daiichi Sankyo Development
Eudract number
2013-004890-28
Clinicaltrials.gov Identifier
Research summary
The study purpose is to determine if quizartinib is a safe and effective treatment compared to standard chemotherapy in patients who have acute myeloid leukaemia (AML),who possess the FLT3 gene mutation, and have not responded to or have relapsed after standard forms of chemotherapy. AML patients who have this FLT-3 mutation (or alteration) in their genetic material are associated with having a poorer prognosis than those who do not. The objectives are therefore to compare the overall survival , and event free survival, in the quizartinib group versus the standard chemotherapy group.
Quizartinib is an experimental anti-cancer drug that changes the activity of the FLT-3 mutation. The study will be conducted in the US, Canada, Australia and Europe including 8 sites in the UK. It is expected that 326 patients will take part in this open label randomised study. This means study doctor is not able to influence which treatment is assigned to the patient but both doctor and patient will know which treatment has been assigned. Two out of three patients will receive quizartinib, and one patient out of three will receive standard chemotherapy.
Patients will take either quizartinib tablets once daily or one of three chemotherapy treatments in the prescribed dose determined by the protocol. Patients will attend a number of study visits in which procedures (e.g blood tests, physical exams, chest x-rays, echocardiograms and bone marrow samples) will be conducted to determine the safety and effectiveness of quizartinib versus standard chemotherapy.
Patients who receive quizartinib or the chemotherapy LoDAC will remain on treatment as long as they receive benefit from the treatment or until their study doctor or themselves decide to withdraw. Patients assigned the chemotherapy MEC or FLAG-IDA will receive one cycle and may receive a second cycle at the investigator's discretion. Treatment should be discontinued if there is no evidence of response, patient disease progression, or if patient decides to withdraw.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/0130
Date of REC Opinion
18 Jun 2014
REC opinion
Further Information Favourable Opinion