Daunorubicine en cytarabine met of zonder uproleselan bij de behandeling van oudere volwassen patiënten met acute myeloïde leukemie die intensieve inductiechemotherapie krijgen

Een gerandomiseerde fase II/III-studie van conventionele chemotherapie +/- Uproleselan (GMI-1271) bij oudere volwassenen met acute myeloïde leukemie die intensieve inductiechemotherapie krijgen

Sponsors

Hoofdsponsor: National Cancer Institute (NCI)

Bron National Cancer Institute (NCI)
Korte samenvatting

Deze fase II/III-studie bestudeert hoe goed daunorubicine en cytarabine met of zonder uproleselan werkt bij de behandeling van oudere volwassen patiënten met acute myeloïde leukemie die intensieve inductiechemotherapie. Geneesmiddelen die worden gebruikt bij chemotherapie, zoals daunorubicine en cytarabine, werken op verschillende manieren om de groei van kankercellen te stoppen, hetzij door de cellen, door te voorkomen dat ze zich delen, of door te voorkomen dat ze zich verspreiden. Uproleselan mei voorkomen dat kanker terugkeert of erger wordt. Daunorubicine en cytarabine geven met: uproleselan werkt mogelijk beter bij de behandeling van patiënten met acute myeloïde leukemie in vergelijking met alleen daunorubicine en cytarabine.

gedetailleerde beschrijving

PRIMAIRE DOELEN: I. Vergelijk de gebeurtenisvrije overleving (EFS) van daunorubicine, cytarabine plus uproleselan versus daunorubicine en cytarabine bij proefpersonen >= 60 jaar met niet eerder behandeld acuut myeloïde leukemie. (Fase II) II. Vergelijk de totale overleving (OS) van de daunorubicine, cytarabine plus uproleselan tot daunorubicine en cytarabine in deze patiëntenpopulatie. (Fase III) SECUNDAIRE DOELSTELLINGEN: I. Bepaal de percentages van complete remissie (CR), complete remissie met onvolledige telling herstel (CRi), volledige remissie met onvolledig hematopoëtisch herstel (CRh) en cytogenetische complete remissie (CCyR) voor elk chemotherapieregime. II. Bepaal de totale overleving (OS) en de remissieduur van patiënten voor elk chemotherapie regime. III. Beschrijf de frequentie en ernst van bijwerkingen voor patiënten voor elke chemotherapie regime. IV. Beschrijf de interactie tussen ziekte vóór de behandeling en patiëntkenmerken, waaronder: morfologie, cytogenetica, moleculair genetische kenmerken, aantal witte bloedcellen (WBC) en hemogram en prestatiestatus op klinische resultaten. CORRELATIEVE WETENSCHAPPELIJKE DOELSTELLINGEN: I. Correleer specifieke karyotypegroepen (normaal of verschillende primaire en secundaire chromosomale) afwijkingen) met klinische en laboratoriumparameters en met responspercentages, respons duur, overleving en genezing bij patiënten die worden behandeld met verschillende inductie- en post-inductie regimes. II. Correleer specifieke karyotypegroepen met geselecteerde moleculaire afwijkingen en met meetbare restziekte. III. Om karyotypeveranderingen te bepalen aan het einde van consolidatie en de invloed van het type verandering (of geen verandering) in karyotype aan het einde van de consolidatie op het volgende klinische beloop. IV. Om karyotypeveranderingen bij terugval te bepalen en de invloed van het type verandering (of geen verandering) in karyotype bij terugval op een volgend klinisch beloop. OVERZICHT: Patiënten worden gerandomiseerd naar 1 van de 2 armen. ARM 1: INDUCTIE: Patiënten krijgen daunorubicine intraveneus (IV) op dag 1-3 en cytarabine via continue intraveneuze infusie (CIVI) gedurende 168 uur op dag 1-7. Patiënten met rest ziekte aangegeven door beenmergonderzoek een tweede inductie krijgen inclusief: daunorubicine IV op dag 1-3 en cytarabine CIVI gedurende 12 uur op dag 1-5. CONSOLIDATIE: Patiënten krijgen cytarabine IV gedurende 3 uur op dag 1-5. Behandeling herhaalt elke 28 dagen gedurende maximaal 3 cycli bij afwezigheid van ziekteprogressie of onaanvaardbaar toxiciteit. ARM 2: INDUCTIE: Patiënten krijgen uproleselan IV QD op dag 1 en vervolgens elke 12 uur op dagen 2-10. Patiënten krijgen ook daunorubicine IV op dag 2-4 en cytrarabine CIVI gedurende 168 uur op dagen 2-8 meer dan 168 uur. Patiënten met resterende ziekte aangegeven door beenmerg onderzoek ontvang een tweede inductie inclusief uprleselan IV QD op dag 1 en daarna elke 12 uur op dagen 2-8, daunorubicine IV op dag 2-3 en cytarabine CIVI meer dan 120 uur op dagen 2-6. CONSOLIDATIE: Patiënten die een CR of CRi bereiken, krijgen uproleselan IV QD op dag 1 en elke 12 uur op dagen 2-8 en cytarabine IV gedurende 3 uur op dagen 2-6. De behandeling wordt elke 28 . herhaald dagen gedurende maximaal 3 cycli in afwezigheid van ziekteprogressie of onaanvaardbare toxiciteit. Na voltooiing van de studiebehandeling worden patiënten gedurende 1 jaar elke 2 maanden gevolgd, om de 3 maanden in jaar 2, en daarna om de 6 maanden gedurende maximaal 5 jaar.

Algemene status Rekruteren
Startdatum 2019-01-16
einddatum 2025-12-01
Primaire voltooiingsdatum 2025-12-01
Fase Fase 2/Fase 3
Studietype Interventionele
Primaire uitkomst
Meten Tijdsspanne
Event-free survival (EFS) (Phase II) Up to 5 years
Totale overleving (OS) (fase III) Tot 5 jaar
Secundair resultaat
Meten Tijdsspanne
EFS rate Up to 1 year
Impact van transplantatie buiten het protocol Tot 5 jaar
Consistentie van het behandelingseffect tussen elke subgroep Van baseline tot 5 jaar
Ziektevrije overleving (DFS) Tijd vanaf het bereiken van een volledige respons op het tijdstip van terugval of overlijden, beoordeeld tot 5 jaar
Volledige remissie (CR) en algehele respons Tot 5 jaar
Incidentie van bijwerkingen Tot 5 jaar
Voorspelling van CR, EFS, DFS en OS door kenmerken voor de behandeling zoals leeftijd, morfologie, cytogenetica, immunofenotype, moleculair genetische kenmerken, aantal leukocyten en hemogram, en prestatiestatus met klinische resultaten Tot 5 jaar
Inschrijving 670
Staat
Interventie

Type interventie: Drug

Interventienaam: Cytarabine

Omschrijving: Given IV

Type interventie: drugs

Interventienaam: Daunorubicine

Omschrijving: gegeven IV

Type interventie: drugs

Interventienaam: Uproleselan

Omschrijving: gegeven IV

Armgroeplabel: Arm II (uproleselan, daunorubicine, cytarabine)

Andere naam: GMI-1271

Geschiktheid

Criteria:

Inclusiecriteria: - Diagnose van acute myeloïde leukemie (AML) op basis van de Wereldgezondheidsorganisatie 2017 (WHO) criteria met uitsluiting van acute promyelocytische leukemie met PML-RARA. - Opmerking: patiënten met myeloïde sarcoom zonder betrokkenheid van het beenmerg, acuut leukemie van ambigue afstamming of blasttransformatie van chronische myeloïde leukemie (CML) komen niet in aanmerking. - Geen activerende mutatie in het Fms-achtige tyrosinekinase-3 (FLT3) gedefinieerd als een verhouding van mutant naar wildtype allel >= 0,05 door capillaire elektroforese of een variant allel fractie van >= 5% door next generation sequencing van beenmerg of perifeer bloed. - Geen bewijs van betrokkenheid van het CZS bij AML. - Geen eerdere chemotherapie voor myelodysplastisch syndroom (MDS), myeloproliferatief neoplasma (MPN) of AML inclusief hypomethylerende middelen (bijv. azacitidine en decitabine), ruxolitinib of lenalidomide met de volgende uitzonderingen: - Noodleukaferese. - Hydroxyurea. - Ondersteuning van groeifactor/cytokine. - All-trans-retinoïnezuur (ATRA). - Eenmalige dosis intrathecaal cytarabine en/of methotrexaat voor patiënten die een lumbaalpunctie om te evalueren op betrokkenheid van het CZS. - Totaal bilirubine =< 3 x bovengrens van normaal (ULN) - Creatinine < 3 x bovengrens van normaal (ULN) OF creatinineklaring >= 30 ml/min/1,73 m^2

Geslacht:

Alle

Minimum leeftijd:

60 jaar

Maximale leeftijd:

Nvt

Gezonde vrijwilligers:

Nee

Algemeen ambtenaar
Achternaam Rol Verbondenheid
Geoffrey L Uy Principal Investigator Alliance for Clinical Trials in Oncology
Plaats
Faciliteit: Toestand: Contact: Onderzoeker:
University of Arkansas for Medical Sciences | Little Rock, Arkansas, 72205, United States Recruiting Site Public Contact 501-686-8274 Muthu Veeraputhiran Principal Investigator
Community Cancer Institute | Clovis, California, 93611, United States Recruiting Site Public Contact 559-387-1827 Haifaa Abdulhaq Principal Investigator
UC San Diego Moores Cancer Center | La Jolla, California, 92093, United States Recruiting Site Public Contact 858-822-5354 [email protected] James K. Mangan Principal Investigator
Loma Linda University Medical Center | Loma Linda, California, 92354, United States Suspended
Cedars Sinai Medical Center | Los Angeles, California, 90048, United States Recruiting Site Public Contact 310-423-8965 Nathan Punwani Principal Investigator
Smilow Cancer Hospital Care Center at Saint Francis | Hartford, Connecticut, 06105, United States Recruiting Site Public Contact 203-785-5702 [email protected] Thomas Prebet Principal Investigator
Yale University | New Haven, Connecticut, 06520, United States Recruiting Site Public Contact 203-785-5702 [email protected] Thomas Prebet Principal Investigator
Delaware Clinical and Laboratory Physicians PA | Newark, Delaware, 19713, United States Recruiting Site Public Contact 302-623-4450 [email protected] Gregory A. Masters Principal Investigator
Helen F Graham Cancer Center | Newark, Delaware, 19713, United States Recruiting Site Public Contact 302-623-4450 [email protected] Gregory A. Masters Principal Investigator
Medical Oncology Hematology Consultants PA | Newark, Delaware, 19713, United States Recruiting Site Public Contact 302-623-4450 [email protected] Gregory A. Masters Principal Investigator
Christiana Care Health System-Christiana Hospital | Newark, Delaware, 19718, United States Recruiting Site Public Contact 302-623-4450 [email protected] Gregory A. Masters Principal Investigator
Saint Alphonsus Cancer Care Center-Boise | Boise, Idaho, 83706, United States Recruiting Site Public Contact 734-712-3671 [email protected] John M. Schallenkamp Principal Investigator
Saint Luke's Cancer Institute - Boise | Boise, Idaho, 83712, United States Recruiting Site Public Contact 208-381-2774 [email protected] Alison K. Conlin Principal Investigator
Saint Alphonsus Cancer Care Center-Caldwell | Caldwell, Idaho, 83605, United States Recruiting Site Public Contact 734-712-3671 [email protected] John M. Schallenkamp Principal Investigator
Kootenai Health - Coeur d'Alene | Coeur d'Alene, Idaho, 83814, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Walter Knox Memorial Hospital | Emmett, Idaho, 83617, United States Suspended
Idaho Urologic Institute-Meridian | Meridian, Idaho, 83642, United States Suspended
Saint Alphonsus Medical Center-Nampa | Nampa, Idaho, 83686, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Kootenai Clinic Cancer Services - Post Falls | Post Falls, Idaho, 83854, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Kootenai Cancer Clinic | Sandpoint, Idaho, 83864, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Illinois CancerCare-Bloomington | Bloomington, Illinois, 61704, United States Suspended
Illinois CancerCare-Canton | Canton, Illinois, 61520, United States Suspended
Memorial Hospital of Carbondale | Carbondale, Illinois, 62902, United States Suspended
SIH Cancer Institute | Carterville, Illinois, 62918, United States Suspended
Illinois CancerCare-Carthage | Carthage, Illinois, 62321, United States Suspended
Centralia Oncology Clinic | Centralia, Illinois, 62801, United States Suspended
Northwestern University | Chicago, Illinois, 60611, United States Recruiting Site Public Contact 312-695-1301 [email protected] Olga Frankfurt Principal Investigator
University of Illinois | Chicago, Illinois, 60612, United States Recruiting Site Public Contact 312-355-3046 Irum Khan Principal Investigator
University of Chicago Comprehensive Cancer Center | Chicago, Illinois, 60637, United States Recruiting Site Public Contact 773-702-8222 [email protected] Olatoyosi M. Odenike Principal Investigator
Cancer Care Specialists of Illinois - Decatur | Decatur, Illinois, 62526, United States Recruiting Site Public Contact 217-876-4740 [email protected] Bryan A. Faller Principal Investigator
Decatur Memorial Hospital | Decatur, Illinois, 62526, United States Suspended
Crossroads Cancer Center | Effingham, Illinois, 62401, United States Recruiting Site Public Contact 217-876-4740 [email protected] Bryan A. Faller Principal Investigator
Illinois CancerCare-Eureka | Eureka, Illinois, 61530, United States Suspended
Illinois CancerCare-Galesburg | Galesburg, Illinois, 61401, United States Suspended
Western Illinois Cancer Treatment Center | Galesburg, Illinois, 61401, United States Suspended
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois, 61443, United States Suspended
Illinois CancerCare-Macomb | Macomb, Illinois, 61455, United States Suspended
Loyola University Medical Center | Maywood, Illinois, 60153, United States Recruiting Site Public Contact 708-226-4357 Kathleen W. Phelan Principal Investigator
UC Comprehensive Cancer Center at Silver Cross | New Lenox, Illinois, 60451, United States Recruiting Site Public Contact 773-702-8222 [email protected] Olatoyosi M. Odenike Principal Investigator
Cancer Care Center of O'Fallon | O'Fallon, Illinois, 62269, United States Recruiting Site Public Contact 217-876-4762 [email protected] Bryan A. Faller Principal Investigator
University of Chicago Medicine-Orland Park | Orland Park, Illinois, 60462, United States Recruiting Site Public Contact 773-702-8222 [email protected] Olatoyosi M. Odenike Principal Investigator
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois, 61350, United States Suspended
Illinois CancerCare-Pekin | Pekin, Illinois, 61554, United States Suspended
Illinois CancerCare-Peoria | Peoria, Illinois, 61615, United States Suspended
Methodist Medical Center of Illinois | Peoria, Illinois, 61636, United States Suspended
Illinois CancerCare-Peru | Peru, Illinois, 61354, United States Suspended
Valley Radiation Oncology | Peru, Illinois, 61354, United States Suspended
Illinois CancerCare-Princeton | Princeton, Illinois, 61356, United States Suspended
Southern Illinois University School of Medicine | Springfield, Illinois, 62702, United States Suspended
Springfield Clinic | Springfield, Illinois, 62702, United States Suspended
Memorial Medical Center | Springfield, Illinois, 62781, United States Suspended
Southwest Illinois Health Services LLP | Swansea, Illinois, 62226, United States Suspended
Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis, Indiana, 46202, United States Recruiting Site Public Contact 317-278-5632 [email protected] Larry D. Cripe Principal Investigator
Mary Greeley Medical Center | Ames, Iowa, 50010, United States Recruiting Site Public Contact 515-956-4132 Debra M. Prow Principal Investigator
McFarland Clinic PC - Ames | Ames, Iowa, 50010, United States Recruiting Site Public Contact 515-239-4734 [email protected] Debra M. Prow Principal Investigator
McFarland Clinic PC-Boone | Boone, Iowa, 50036, United States Recruiting Site Public Contact 515-956-4132 Debra M. Prow Principal Investigator
McFarland Clinic PC-Trinity Cancer Center | Fort Dodge, Iowa, 50501, United States Recruiting Site Public Contact 515-956-4132 Debra M. Prow Principal Investigator
University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa, 52242, United States Recruiting Site Public Contact 800-237-1225 Grerk Sutamtewagul Principal Investigator
McFarland Clinic PC-Jefferson | Jefferson, Iowa, 50129, United States Recruiting Site Public Contact 515-956-4132 Debra M. Prow Principal Investigator
McFarland Clinic PC-Marshalltown | Marshalltown, Iowa, 50158, United States Recruiting Site Public Contact 515-956-4132 Debra M. Prow Principal Investigator
Siouxland Regional Cancer Center | Sioux City, Iowa, 51101, United States Recruiting Site Public Contact 712-252-9326 [email protected] Donald B. Wender Principal Investigator
University of Kansas Cancer Center | Kansas City, Kansas, 66160, United States Recruiting Site Public Contact 913-588-3671 [email protected] Kenneth Byrd Principal Investigator
Lawrence Memorial Hospital | Lawrence, Kansas, 66044, United States Suspended
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas, 67208, United States Recruiting Site Public Contact 316-268-5374 [email protected] Shaker R. Dakhil Principal Investigator
Ascension Via Christi Hospitals Wichita | Wichita, Kansas, 67214, United States Recruiting Site Public Contact 800-362-0070 [email protected] Shaker R. Dakhil Principal Investigator
Cancer Center of Kansas - Wichita | Wichita, Kansas, 67214, United States Recruiting Site Public Contact 316-268-5374 [email protected] Shaker R. Dakhil Principal Investigator
Wesley Medical Center | Wichita, Kansas, 67214, United States Recruiting Site Public Contact 316-268-5374 [email protected] Shaker R. Dakhil Principal Investigator
University of Kentucky/Markey Cancer Center | Lexington, Kentucky, 40536, United States Recruiting Site Public Contact 859-257-3379 Gerhard C. Hildebrandt Principal Investigator
Ochsner Medical Center Jefferson | New Orleans, Louisiana, 70121, United States Recruiting Site Public Contact 504-703-8712 [email protected] Laura E. Finn Principal Investigator
Eastern Maine Medical Center | Bangor, Maine, 04401, United States Suspended
Lafayette Family Cancer Center-EMMC | Brewer, Maine, 04412, United States Recruiting Site Public Contact 800-987-3005 Sarah J. Sinclair Principal Investigator
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Recruiting Site Public Contact 877-442-3324 Daniel J. DeAngelo Principal Investigator
Hickman Cancer Center | Adrian, Michigan, 49221, United States Suspended
Henry Ford Hospital | Detroit, Michigan, 48202, United States Recruiting Site Public Contact 313-916-3721 [email protected] Ding Wang Principal Investigator
Mercy Health Saint Mary's | Grand Rapids, Michigan, 49503, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan, 49503, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Bronson Methodist Hospital | Kalamazoo, Michigan, 49007, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
West Michigan Cancer Center | Kalamazoo, Michigan, 49007, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Toledo Clinic Cancer Centers-Monroe | Monroe, Michigan, 48162, United States Suspended
Mercy Health Mercy Campus | Muskegon, Michigan, 49444, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores, Michigan, 49444, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Spectrum Health Reed City Hospital | Reed City, Michigan, 49677, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Marie Yeager Cancer Center | Saint Joseph, Michigan, 49085, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Munson Medical Center | Traverse City, Michigan, 49684, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Metro Health Hospital | Wyoming, Michigan, 49519, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Fairview Ridges Hospital | Burnsville, Minnesota, 55337, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Mercy Hospital | Coon Rapids, Minnesota, 55433, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Essentia Health Cancer Center | Duluth, Minnesota, 55805, United States Recruiting Site Public Contact 218-786-3308 [email protected] Bret E. Friday Principal Investigator
Fairview Southdale Hospital | Edina, Minnesota, 55435, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Unity Hospital | Fridley, Minnesota, 55432, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Fairview Clinics and Surgery Center Maple Grove | Maple Grove, Minnesota, 55369, United States Suspended
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota, 55109, United States Suspended
Saint John's Hospital - Healtheast | Maplewood, Minnesota, 55109, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Abbott-Northwestern Hospital | Minneapolis, Minnesota, 55407, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Hennepin County Medical Center | Minneapolis, Minnesota, 55415, United States Suspended
Health Partners Inc | Minneapolis, Minnesota, 55454, United States Active, not recruiting
Monticello Cancer Center | Monticello, Minnesota, 55362, United States Suspended
New Ulm Medical Center | New Ulm, Minnesota, 56073, United States Suspended
North Memorial Medical Health Center | Robbinsdale, Minnesota, 55422, United States Suspended
Mayo Clinic in Rochester | Rochester, Minnesota, 55905, United States Suspended
Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud, Minnesota, 56303, United States Recruiting Site Public Contact 877-229-4907 [email protected] Donald J. Jurgens Principal Investigator
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota, 55416, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Regions Hospital | Saint Paul, Minnesota, 55101, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
United Hospital | Saint Paul, Minnesota, 55102, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Saint Francis Regional Medical Center | Shakopee, Minnesota, 55379, United States Suspended
Lakeview Hospital | Stillwater, Minnesota, 55082, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Ridgeview Medical Center | Waconia, Minnesota, 55387, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Rice Memorial Hospital | Willmar, Minnesota, 56201, United States Suspended
Minnesota Oncology Hematology PA-Woodbury | Woodbury, Minnesota, 55125, United States Suspended
Fairview Lakes Medical Center | Wyoming, Minnesota, 55092, United States Suspended
Parkland Health Center-Bonne Terre | Bonne Terre, Missouri, 63628, United States Suspended
Saint Francis Medical Center | Cape Girardeau, Missouri, 63703, United States Suspended
Southeast Cancer Center | Cape Girardeau, Missouri, 63703, United States Suspended
Siteman Cancer Center at West County Hospital | Creve Coeur, Missouri, 63141, United States Recruiting Site Public Contact 800-600-3606 [email protected] Geoffrey L. Uy Principal Investigator
Parkland Health Center - Farmington | Farmington, Missouri, 63640, United States Recruiting Site Public Contact 314-996-5569 Bryan A. Faller Principal Investigator
Capital Region Southwest Campus | Jefferson City, Missouri, 65109, United States Suspended
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting Site Public Contact 800-600-3606 [email protected] Geoffrey L. Uy Principal Investigator
Siteman Cancer Center-South County | Saint Louis, Missouri, 63129, United States Recruiting Site Public Contact 800-600-3606 [email protected] Geoffrey L. Uy Principal Investigator
Missouri Baptist Medical Center | Saint Louis, Missouri, 63131, United States Suspended
Siteman Cancer Center at Christian Hospital | Saint Louis, Missouri, 63136, United States Recruiting Site Public Contact 800-600-3606 [email protected] Geoffrey L. Uy Principal Investigator
Siteman Cancer Center at Saint Peters Hospital | Saint Peters, Missouri, 63376, United States Recruiting Site Public Contact 800-600-3606 [email protected] Geoffrey L. Uy Principal Investigator
Sainte Genevieve County Memorial Hospital | Sainte Genevieve, Missouri, 63670, United States Suspended
Missouri Baptist Sullivan Hospital | Sullivan, Missouri, 63080, United States Suspended
Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills, Missouri, 63127, United States Suspended
Community Hospital of Anaconda | Anaconda, Montana, 59711, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Billings Clinic Cancer Center | Billings, Montana, 59101, United States Recruiting Site Public Contact 800-996-2663 [email protected] John M. Schallenkamp Principal Investigator
Bozeman Deaconess Hospital | Bozeman, Montana, 59715, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana, 59405, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Great Falls Clinic | Great Falls, Montana, 59405, United States Suspended
Saint Peter's Community Hospital | Helena, Montana, 59601, United States Suspended
Kalispell Regional Medical Center | Kalispell, Montana, 59901, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Community Medical Hospital | Missoula, Montana, 59804, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Nebraska Methodist Hospital | Omaha, Nebraska, 68114, United States Recruiting Site Public Contact 402-354-5144 Stefano R. Tarantolo Principal Investigator
OptumCare Cancer Care at Charleston | Las Vegas, Nevada, 89102, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
OptumCare Cancer Care at Fort Apache | Las Vegas, Nevada, 89148, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas, Nevada, 89169, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States Recruiting Site Public Contact 800-639-6918 [email protected] Swaroopa Yerrabothala Principal Investigator
Northwell Health/Center for Advanced Medicine | Lake Success, New York, 11042, United States Recruiting Site Public Contact 516-734-8896 Jonathan E. Kolitz Principal Investigator
North Shore University Hospital | Manhasset, New York, 11030, United States Recruiting Site Public Contact 516-734-8896 Jonathan E. Kolitz Principal Investigator
Long Island Jewish Medical Center | New Hyde Park, New York, 11040, United States Recruiting Site Public Contact 516-734-8896 Jonathan E. Kolitz Principal Investigator
Mount Sinai Hospital | New York, New York, 10029, United States Recruiting Site Public Contact 212-824-7309 [email protected] Michal Bar-Natan Principal Investigator
University of Rochester | Rochester, New York, 14642, United States Recruiting Site Public Contact 585-275-5830 Paul M. Barr Principal Investigator
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, 27599, United States Active, not recruiting
Duke University Medical Center | Durham, North Carolina, 27710, United States Recruiting Site Public Contact 888-275-3853 Harry P. Erba Principal Investigator
East Carolina University | Greenville, North Carolina, 27834, United States Recruiting Site Public Contact 252-744-1015 [email protected] Darla K. Liles Principal Investigator
Wake Forest Baptist Health - Wilkes Medical Center | Wilkesboro, North Carolina, 28659, United States Recruiting Site Public Contact 888-716-9253 Rupali R. Bhave Principal Investigator
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States Recruiting Site Public Contact 336-713-6771 Rupali R. Bhave Principal Investigator
Sanford Bismarck Medical Center | Bismarck, North Dakota, 58501, United States Recruiting Site Public Contact 701-323-5760 [email protected] Preston D. Steen Principal Investigator
Sanford Broadway Medical Center | Fargo, North Dakota, 58122, United States Recruiting Site Public Contact 701-323-5760 [email protected] Preston D. Steen Principal Investigator
Sanford Roger Maris Cancer Center | Fargo, North Dakota, 58122, United States Recruiting Site Public Contact 701-234-6161 [email protected] Preston D. Steen Principal Investigator
Case Western Reserve University | Cleveland, Ohio, 44106, United States Recruiting Site Public Contact 800-641-2422 [email protected] Benjamin K. Tomlinson Principal Investigator
MetroHealth Medical Center | Cleveland, Ohio, 44109, United States Suspended
Ohio State University Comprehensive Cancer Center | Columbus, Ohio, 43210, United States Recruiting Site Public Contact 800-293-5066 [email protected] Alice S. Mims Principal Investigator
Mercy Health Perrysburg Cancer Center | Perrysburg, Ohio, 43551, United States Suspended
Mercy Health - Saint Anne Hospital | Toledo, Ohio, 43623, United States Suspended
Toledo Clinic Cancer Centers-Toledo | Toledo, Ohio, 43623, United States Recruiting Site Public Contact 800-444-3561 Rex B. Mowat Principal Investigator
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Recruiting Site Public Contact 405-271-8777 [email protected] Adam S. Asch Principal Investigator
Saint Alphonsus Medical Center-Baker City | Baker City, Oregon, 97814, United States Suspended
Saint Alphonsus Medical Center-Ontario | Ontario, Oregon, 97914, United States Recruiting Site Public Contact 406-969-6060 [email protected] John M. Schallenkamp Principal Investigator
Providence Portland Medical Center | Portland, Oregon, 97213, United States Recruiting Site Public Contact 503-215-2614 [email protected] Alison K. Conlin Principal Investigator
Providence Saint Vincent Medical Center | Portland, Oregon, 97225, United States Recruiting Site Public Contact 503-215-2614 [email protected] Alison K. Conlin Principal Investigator
Rhode Island Hospital | Providence, Rhode Island, 02903, United States Recruiting Site Public Contact 401-444-1488 Pamela Egan Principal Investigator
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Recruiting Site Public Contact 843-792-9321 [email protected] Robert K. Stuart Principal Investigator
Saint Francis Hospital | Greenville, South Carolina, 29601, United States Recruiting Site Public Contact 864-603-6213 [email protected] Robert D. Siegel Principal Investigator
Saint Francis Cancer Center | Greenville, South Carolina, 29607, United States Recruiting Site Public Contact 864-603-6213 [email protected] Robert D. Siegel Principal Investigator
Prisma Health Cancer Institute - Eastside | Greenville, South Carolina, 29615, United States Recruiting Site Public Contact 864-522-2066 [email protected] Ki Y. Chung Principal Investigator
Sanford Cancer Center Oncology Clinic | Sioux Falls, South Dakota, 57104, United States Recruiting Site Public Contact 605-312-3320 [email protected] Preston D. Steen Principal Investigator
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota, 57117-5134, United States Recruiting Site Public Contact 605-312-3320 [email protected] Preston D. Steen Principal Investigator
Vanderbilt University/Ingram Cancer Center | Nashville, Tennessee, 37232, United States Recruiting Site Public Contact 800-811-8480 Stephen A. Strickland Principal Investigator
Marshfield Medical Center-EC Cancer Center | Eau Claire, Wisconsin, 54701, United States Recruiting Site Public Contact 800-782-8581 [email protected] Seth O. Fagbemi Principal Investigator
Marshfield Medical Center-Marshfield | Marshfield, Wisconsin, 54449, United States Recruiting Site Public Contact 800-782-8581 [email protected] Seth O. Fagbemi Principal Investigator
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin, 54548, United States Recruiting Site Public Contact 800-782-8581 [email protected] Seth O. Fagbemi Principal Investigator
Cancer Center of Western Wisconsin | New Richmond, Wisconsin, 54017, United States Recruiting Site Public Contact 952-993-1517 [email protected] Daniel M. Anderson Principal Investigator
Marshfield Clinic Stevens Point Center | Stevens Point, Wisconsin, 54482, United States Recruiting Site Public Contact 800-782-8581 [email protected] Seth O. Fagbemi Principal Investigator
Marshfield Medical Center - Weston | Weston, Wisconsin, 54476, United States Recruiting Site Public Contact 800-782-8581 [email protected] Seth O. Fagbemi Principal Investigator
Billings Clinic-Cody | Cody, Wyoming, 82414, United States Suspended
Welch Cancer Center | Sheridan, Wyoming, 82801, United States Suspended
Locatie Landen

United States

Verificatiedatum

2021-05-01

Verantwoordelijke partij

Type: Sponsor

Heeft uitgebreide toegang Nee
Aantal wapens 2
Arm groep

Label: Arm I (daunorubicin, cytarabine)

Type: Active Comparator

Omschrijving: INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-3 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Label: Arm II (uproleselan, daunorubicine, cytarabine)

Type: Experimenteel

Omschrijving: INDUCTIE: Patiënten krijgen uproleselan IV QD op dag 1 en vervolgens elke 12 uur op dag 2-10. Patiënten krijgen ook daunorubicine IV op dagen 2-4 en cytrarabine CIVI gedurende 168 uur op dagen 2-8 gedurende 168 uur. Patiënten met restziekte die door beenmergonderzoek zijn aangegeven, krijgen een tweede inductie, inclusief uprleselan IV QD op dag 1 en vervolgens elke 12 uur op dagen 2-8, daunorubicine IV op dag 2-3 en cytarabine CIVI gedurende 120 uur op dag 2-6 . CONSOLIDATIE: Patiënten die een CR of CRi bereiken, krijgen uproleselan IV QD op dag 1 en elke 12 uur op dagen 2-8 en cytarabine IV gedurende 3 uur op dag 2-6. De behandeling wordt elke 28 dagen herhaald gedurende maximaal 3 cycli bij afwezigheid van ziekteprogressie of onaanvaardbare toxiciteit.

Bestudeer ontwerpinformatie

Toewijzing: Gerandomiseerd

Interventiemodel: Parallelle toewijzing

Primair doel: Behandeling

Maskeren: Geen (Open Etiket)

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