Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations Clinical Trial
Official title:
Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia
This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.
| Status | Recruiting |
| Enrollment | 322 |
| Est. completion date | October 2024 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: 1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification 2. Presence of FLT3-ITD and/or D835 mutation(s) 3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML 4. Age = 18 years and = 75 years 5. Adequate hepatic function 6. Adequate renal functions 7. ECOG performance status = 3 Exclusion Criteria: 1. Known clinically active central nervous system(CNS) leukemia 2. Severe liver disease 3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed. 5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Alberta | Edmonton | Alberta |
| France | Hospital Avicenne | Bobigny | |
| France | CHU Grenoble Alpes | Grenoble | |
| France | Hospital Center of Versailles (Le Chesnay) | Le Chesnay | |
| France | Hospital Claude Huriez - Chru Lille | Lille | |
| France | Institut Paoli-Calmettes | Marseille | |
| France | CHU de Nantes - Hôtel Dieu | Nantes | |
| France | University Hospital Nice L'Archet | Nice | |
| France | Hôpital St Louis | Paris | |
| France | CHU de Bordeaux | Pessac | |
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite | |
| France | CHU de Poitiers | Poitiers | |
| France | Institut Universitaire du Cancer Toulouse | Toulouse | |
| Germany | Klinikum Chemnitz gGmbH | Chemnitz | |
| Germany | Technische Universität Dresden | Dresden | |
| Germany | Universitätsklinikum Essen (AöR) | Essen | |
| Germany | Universitätsklinikum Frankfurt | Frankfurt | |
| Germany | Universitätsklinikum Halle (Saale) | Halle | |
| Germany | Universitätsklinikum Münster | Münster | |
| Italy | AOU Policlinico Sant'Orsola-Malpighi | Bologna | |
| Italy | ASST Spedali Civili di Brescia | Brescia | |
| Italy | AOU Careggi | Firenze | |
| Italy | IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | |
| Italy | IRCCS San Raffaele Hospital | Milan | |
| Italy | IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Istituto Europeo di Oncologia | Milano | |
| Italy | Aorn Antonio Cardarelli | Napoli | |
| Italy | AOU Federico II | Napoli | |
| Italy | AOU Maggiore della Carità | Novara | |
| Italy | AO Ospedali Riuniti Villa Sofia-Cervello | Palermo | |
| Italy | AO Ospedali Riuniti Marche Nord | Pesaro | |
| Italy | Ospedale Santa Maria delle Croci di Ravenna | Ravenna | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli | Roma | |
| Italy | Policlinico Tor Vergata | Roma | RM |
| Italy | A.O.U. Città della Salute e della Scienza di Torino | Torino | |
| Italy | AO Ordine Mauriziano di Torino | Torino | |
| Italy | Policlinico GB Rossi, University Hospital Verona | Verona | |
| Italy | AULSS n 8 Berica Ospedale San Bortolo | Vicenza | |
| Spain | Complejo Hospitalario Universitario A Coruna | A Coruña | |
| Spain | San Pedro de Alcantara Hospital | Cáceres | |
| Spain | Reina Sofia University Hospital | Córdoba | |
| Spain | Hospital Universitario de Donostia | Donostia San Sebastian | |
| Spain | Fundacion Jimenez Diaz | Madrid | |
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia | Madrid | |
| Spain | Hospital Ramon y Cajal | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Central de Asturias (HUCA) | Oviedo | Asturias |
| Spain | Hospital Clinico Universitario de Salamanca | Salamanca | |
| Spain | Hospital U. Marques de Valdecilla | Santander | |
| Spain | Hospital Clinico Universitario de Santiago | Santiago De Compostela | |
| Spain | Hospital U. Virgen del Rocio | Sevilla | Andalucia |
| Spain | Hospital Universitario y Politecnico La Fe | Valencia | |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | University of Chicago | Chicago | Illinois |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Karmanos Cancer Center | Detroit | Michigan |
| United States | University of Florida | Gainesville | Florida |
| United States | Kansas University | Kansas City | Kansas |
| United States | City of Hope National Medical Center | Sacramento | California |
| United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
| United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Arog Pharmaceuticals, Inc. |
United States, Canada, France, Germany, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Event-free survival (EFS) | 3 years | ||
| Secondary | Overall Survival | 3 years | ||
| Secondary | Relapse-free Survival (RFS) | 3 years | ||
| Secondary | Complete remission rate (CR) | 3 years | ||
| Secondary | MRD negative complete remission rate | 3 years |