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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001600-29 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crenolanib | Experimental | Crenolanib following salvage chemotherapy |
|
| Placebo | Placebo Comparator | Placebo following salvage chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crenolanib | Drug | Crenolanib will be administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 years | |
| Relapse-free Survival (RFS) | 3 years | |
| Complete remission rate (CR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eunice Wang, MD | Roswell Park Cancer Institute, Buffalo, New York, United States, 14263 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Sacramento | California | 95817 | United States | ||
| UC Davis Comprehensive Cancer Center |
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| Cytarabine | Drug | HAM regimen FLAG-Ida |
|
| Mitoxantrone | Drug | HAM regimen |
|
| Placebo Oral Tablet | Drug | Placebo will be administered orally |
|
| Fludarabine | Drug | FLAG-Ida regimen |
|
| Idarubicin | Drug | FLAG-Ida regimen |
|
| G-CSF | Drug | FLAG-Ida regimen |
|
| 3 years |
| MRD negative complete remission rate | 3 years |
| Sacramento |
| California |
| 95817 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Kansas University | Kansas City | Kansas | 666160 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27104 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada |
| Hospital Avicenne | Bobigny | 93000 | France |
| CHU Grenoble Alpes | Grenoble | 38043 | France |
| Hospital Center of Versailles (Le Chesnay) | Le Chesnay | 78157 | France |
| Hospital Claude Huriez - Chru Lille | Lille | 59037 | France |
| Institut Paoli-Calmettes | Marseille | 13009 | France |
| CHU de Nantes - Hôtel Dieu | Nantes | 44093 | France |
| University Hospital Nice L'Archet | Nice | 06200 | France |
| Hôpital St Louis | Paris | 75010 | France |
| CHU de Bordeaux | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69494 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Institut Universitaire du Cancer Toulouse | Toulouse | 31059 | France |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Technische Universität Dresden | Dresden | Germany |
| Universitätsklinikum Essen (AöR) | Essen | 45147 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Universitätsklinikum Halle (Saale) | Halle | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Policlinico Tor Vergata | Roma | RM | 00133 | Italy |
| AOU Policlinico Sant'Orsola-Malpighi | Bologna | 40138 | Italy |
| ASST Spedali Civili di Brescia | Brescia | 25123 | Italy |
| AOU Careggi | Florence | 50134 | Italy |
| IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | 47014 | Italy |
| IRCCS San Raffaele Hospital | Milan | 20132 | Italy |
| IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Aorn Antonio Cardarelli | Naples | 80131 | Italy |
| AOU Federico II | Naples | 80131 | Italy |
| AOU Maggiore della Carità | Novara | 28100 | Italy |
| AO Ospedali Riuniti Villa Sofia-Cervello | Palermo | Italy |
| AO Ospedali Riuniti Marche Nord | Pesaro | 61122 | Italy |
| Ospedale Santa Maria delle Croci di Ravenna | Ravenna | 48121 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| A.O.U. Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| AO Ordine Mauriziano di Torino | Torino | 10128 | Italy |
| Policlinico GB Rossi, University Hospital Verona | Verona | 37134 | Italy |
| AULSS n 8 Berica Ospedale San Bortolo | Vicenza | 36100 | Italy |
| Hospital U. Virgen del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital U. Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Central de Asturias (HUCA) | Oviedo | Principality of Asturias | 33011 | Spain |
| Complejo Hospitalario Universitario A Coruna | A Coruña | 15006 | Spain |
| San Pedro de Alcantara Hospital | Cáceres | 10003 | Spain |
| Reina Sofia University Hospital | Córdoba | 14004 | Spain |
| Hospital Universitario de Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia | Madrid | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C577197 | crenolanib |
| D003561 | Cytarabine |
| D008942 | Mitoxantrone |
| C024352 | fludarabine |
| D015255 | Idarubicin |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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