NCT04112589

A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment

A Multicenter, Prospective, Non-randomized, Phase I-II Trial to Assess the Efficacy and Safety of the Combination of Oral Quizartinib and the FLAG-IDA Chemotherapy Regimen in First Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, non-randomized, Phase I-II trial to assess the efficacy and safety of the combination of oral quizartinib and FLAG-IDA chemotherapy schedule (FLAG-QUIDA regimen) in first relapsed/refractory AML (acute myeloid leukemia) patients.

Detailed description

Patients of approximately 20 sites (in Spain and Portugal) will receive FLAG-QUIDA regimen followed by transplantation, when possible, with up to 3 optional consolidation cycles. All patients in CR/CRi (complete remission / complete remission with incomplete hematologic recovery) will receive a maintenance schedule. A Phase I (dose escalation) will be performed at 40 mg x 14 days of quizartinib in the first 3 patients, and if no dose-limiting toxicity (DLT) is observed, the next cohort of patients will receive 60 mg x 14 days. There is also the possibility of de-escalation cohorts at 60 mg x 7 days and at 40 mg x 7 days. Patients participating in the Phase I will receive the allocated dose level, and therefore, they must not receive strong CYP3A4 inhibitors concomitantly with quizartinib The Phase II will include 68 patients treated at the RP2D (recommended phase 2 dose). A 1-year maintenance schedule starting at 30 mg will be increased to 60 mg/day if appropriate. Patients will be followed up for a minimum period of 1 year since the first visit of the last patient included.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Quizartinib	Quizartinib at different doses in the phase I (40mg-14 days; 60mg-14 days; 60mg-7days, 40mg-7days). RP2D in the phase II part.
DRUG	Fludarabine	30 mg/m2 intravenous days 1 to 4 of the cycle
DRUG	Cytarabine	2 g/m 2 intravenous days 1 to 4 (1 g/m2 in patients older than 59) of the cycle
DRUG	Idarubicin	10 mg/ 2 intravenous days 1 to 3 of the cycle
DRUG	glycosylated G-CSF	daily dose of 300 mcg/m 2 , from day -1 until day 5 of the cycle

Timeline

• Start date: 2019-12-26
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-10-02
• Last updated: 2022-03-14

Locations

20 sites across 1 country: Spain