Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT04112589
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital General Universitario de Alicante, Alicante, , Spain
Institut Català D'Oncologia-Hospital Germans Trias I Pujol, Badalona, , Spain
Institut Català D'Oncologia-Hospital Duran I Reynals, Bellvitge, , Spain
Hospital Universitario Puerta Del Mar, Cadiz, , Spain
Complexo Hospitalario Universitario A Coruña, Coruña, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
ICO Girona - Hospital Josep Trueta, Girona, , Spain
Hospital Universitario de Jerez de La Frontera, Jerez De La Frontera, , Spain
Complejo Hospitalario de Gran Canaria Dr. Negrin, Las Palmas De Gran Canaria, , Spain
Complejo Hospitalario Universitario Insular-Materno Infantil, Las Palmas De Gran Canaria, , Spain
Hospital Ramón Y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen de La Victoria, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitari Son Espases, Palma De Mallorca, , Spain
Clínica Universitaria de Navarra, Pamplona, , Spain
Hospital Universitario Virgen Del Rocío, Sevilla, , Spain
Hospital Universitari Joan Xxiii de Tarragona, Tarragona, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Contact Details
Name: Pau Montesinos, MD
Affiliation: Trial Coordinator, Institution Contact
Role: STUDY_DIRECTOR
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