Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
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Studienlocations (3 von 149)
Universitaetsklinikum Augsburg 86156 Augsburg (Bayern) GermanyAbgeschlossen» Google-MapsCharite - Universitaetsmedizin Berlin, Campus Benjamin Franklin 12200 Berlin (Berlin) GermanyAbgeschlossen» Google-MapsUniversitaetsklinikum Dresden 01307 Dresden (Sachsen) GermanyAbgeschlossen» Google-Maps
Universitaetsklinikum Duesseldorf 40225 Duesseldorf (Nordrhein-Westfalen) GermanyAbgeschlossen» Google-MapsUniversitaetsklinikum Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyAbgeschlossen» Google-MapsUniversitaetsklinikum Jena 07747 Jena (Thüringen) GermanyAbgeschlossen» Google-MapsUniversitaetsklinikum Schleswig-Holstein 24105 Kiel (Schleswig-Holstein) GermanyAbgeschlossen» Google-MapsKlinikum der LMU Muenchen 81377 Muenchen (Bayern) GermanyAbgeschlossen» Google-MapsCity of Hope National Medical Center 91010 Duarte United StatesRekrutierend» Google-MapsUniversity of California Irvine 92868-3201 Orange United StatesRekrutierend» Google-MapsUniversity of California San Francisco 94143 San Francisco United StatesRekrutierend» Google-MapsAdventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando 32804 Orlando United StatesRekrutierend» Google-MapsCleveland Clinic Foundation 44195 Cleveland United StatesRekrutierend» Google-MapsSaint Francis Hospital, Inc 29607 Greenville United StatesRekrutierend» Google-MapsUniversity of Texas MD Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-MapsCanberra Hospital 2605 Garran AustraliaRekrutierend» Google-MapsLiverpool Hospital 2170 Liverpool AustraliaRekrutierend» Google-MapsRoyal North Shore Hospital 2065 St Leonards AustraliaRekrutierend» Google-MapsWestmead Hospital 2145 Westmead AustraliaRekrutierend» Google-MapsRoyal Brisbane and Womens Hospital 4029 Herston AustraliaRekrutierend» Google-MapsPrincess Alexandra Hospital 4102 Woolloongabba AustraliaRekrutierend» Google-MapsRoyal Adelaide Hospital 5000 Adelaide AustraliaRekrutierend» Google-MapsMonash Medical Centre 3168 Clayton AustraliaRekrutierend» Google-MapsAustin Health, Austin Hospital 3084 Heidelberg AustraliaRekrutierend» Google-MapsPeter MacCallum Cancer Centre 3000 Melbourne AustraliaRekrutierend» Google-MapsThe Alfred Hospital 3004 Melbourne AustraliaRekrutierend» Google-MapsFiona Stanley Hospital 6150 Murdoch AustraliaRekrutierend» Google-MapsMedizinische Universitaet Graz 8036 Graz AustriaRekrutierend» Google-MapsMedizinische Universitaet Innsbruck 6020 Innsbruck AustriaRekrutierend» Google-MapsOrdensklinikum Linz Elisabethinen 4020 Linz AustriaRekrutierend» Google-MapsHanusch Krankenhaus 1140 Wien AustriaRekrutierend» Google-MapsInstitut Jules Bordet 1070 Anderlecht BelgiumRekrutierend» Google-MapsAZ Sint-Jan Brugge-Oostende AV 8000 Brugge BelgiumRekrutierend» Google-MapsUniversite Catholique de Louvain Cliniques Universitaires Saint Luc 1200 Bruxelles BelgiumRekrutierend» Google-MapsUniversitair Ziekenhuis Antwerpen 2650 Edegem BelgiumRekrutierend» Google-MapsUniversitair Ziekenhuis Gent 9000 Gent BelgiumRekrutierend» Google-MapsJessa Ziekenhuis - Campus Virga Jesse 3500 Hasselt BelgiumRekrutierend» Google-MapsCentre Hospitalier Universitaire de Liege - Sart Tilman 4000 Liege BelgiumRekrutierend» Google-MapsAZ Delta Campus Rumbeke 8800 Roeselare BelgiumRekrutierend» Google-MapsCentre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur 5530 Yvoir BelgiumRekrutierend» Google-MapsUniversity Multiprofile Hospital for Active Treatment Sveti Georgi EAD 40002 Plovdiv BulgariaRekrutierend» Google-MapsSpecialized Hospital for Active Treatment of Hematology Diseases EAD 1797 Sofia BulgariaRekrutierend» Google-MapsTom Baker Cancer Centre T2N 4N2 Calgary CanadaRekrutierend» Google-MapsCancer Care Manitoba R3H 0V9 Winnipeg CanadaRekrutierend» Google-MapsQueen Elizabeth II, Health Sciences Centre B3H 1V8 Halifax CanadaRekrutierend» Google-MapsPrincess Margaret Cancer Centre M5G 2M9 Toronto CanadaRekrutierend» Google-MapsCEMTL Hopital Maisonneuve Rosemont H1T 2M4 Montreal CanadaRekrutierend» Google-MapsFundacion Arturo Lopez Perez 7501066 Santiago ChileRekrutierend» Google-MapsInmunocel 7580206 Santiago ChileRekrutierend» Google-MapsAalborg Universitetshospital 9000 Aalborg DenmarkRekrutierend» Google-MapsAarhus Universitetshospital 8200 Aarhus N DenmarkRekrutierend» Google-MapsRigshospitalet 2100 København Ø DenmarkRekrutierend» Google-MapsOdense Universitetshospital 5000 Odense DenmarkRekrutierend» Google-MapsHelsinki University Hospital 00029 Helsinki FinlandRekrutierend» Google-MapsTurku University Hospital 20521 Turku FinlandRekrutierend» Google-MapsHôpital Henri Mondor 94010 Creteil FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Dijon - Hopital du Bocage 21000 Dijon FranceRekrutierend» Google-MapsCentre Hospitalier de Versailles 78157 Le Chesnay Cedex FranceRekrutierend» Google-MapsCentre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez 59000 Lille FranceRekrutierend» Google-MapsInstitut Paoli Calmettes 13009 Marseille FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu 44093 Nantes Cedex 1 FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire Archet 2 06202 Nice cedex 3 FranceRekrutierend» Google-MapsHôpital Saint Louis 75010 Paris FranceRekrutierend» Google-MapsHopital Saint Antoine 75012 Paris FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque 33604 Pessac Cedex FranceRekrutierend» Google-MapsHopital Lyon Sud 69645 Pierre Benite FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Rennes 35000 Rennes Cedex 9 FranceRekrutierend» Google-MapsInstitut Universitaire du Cancer Toulouse Oncopole 31059 Toulouse cedex 9 FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nancy - Hopital de Brabois 54511 Vandoeuvre les Nancy Cedex FranceRekrutierend» Google-MapsEvangelismos Hospital 10676 Athens GreeceRekrutierend» Google-MapsLaiko General Hospital of Athens 11527 Athens GreeceRekrutierend» Google-MapsAttiko General University Hospital 12462 Athens GreeceRekrutierend» Google-MapsUniversity Hospital of Heraklion 71500 Heraklion GreeceRekrutierend» Google-MapsUniversity Hospital of Ioannina 45500 Ioannina GreeceRekrutierend» Google-MapsUniversity Hospital of Larissa 41110 Larissa GreeceRekrutierend» Google-MapsUniversity Hospital of Patras 26504 Patras GreeceRekrutierend» Google-MapsGeneral Hospital of Thessaloniki Georgios Papanikolaou 57010 Thessaloniki GreeceRekrutierend» Google-MapsSemmelweis Egyetem 1088 Budapest HungaryRekrutierend» Google-MapsDel-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet 1097 Budapest HungaryRekrutierend» Google-MapsDebreceni Egyetem Klinikai Kozpont 4032 Debrecen HungaryRekrutierend» Google-MapsHeves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet 3300 Eger HungaryRekrutierend» Google-MapsSzabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz 4400 Nyiregyhaza HungaryRekrutierend» Google-MapsAzienda Ospedaliera Universitaria Consorziale Policlinico di Bari 70124 Bari ItalyRekrutierend» Google-MapsAzienda Socio Sanitaria Territoriale Papa Giovanni xxiii 24127 Bergamo ItalyRekrutierend» Google-MapsIRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola 40138 Bologna ItalyRekrutierend» Google-MapsOspedale Policlinico San Martino IRCCS 16132 Genova ItalyRekrutierend» Google-MapsAzienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II 73100 Lecce ItalyRekrutierend» Google-MapsAzienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo 30174 Mestre (VE) ItalyRekrutierend» Google-MapsFondazione IRCCS Ca Granda Ospedale Maggiore Policlinico 20122 Milano ItalyRekrutierend» Google-MapsAzienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli 80131 Napoli ItalyRekrutierend» Google-MapsAzienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia 06156 Perugia ItalyRekrutierend» Google-MapsAzienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito 65124 Pescara ItalyRekrutierend» Google-MapsAzienda Ospedaliera Policlinico Umberto I 00161 Roma ItalyRekrutierend» Google-MapsAzienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma 37134 Verona ItalyRekrutierend» Google-MapsNagoya University Hospital 466-8560 Nagoya-shi JapanRekrutierend» Google-MapsAkita University Hospital 010-8543 Akita-shi JapanRekrutierend» Google-MapsUniversity of Fukui Hospital 910-1193 Yoshida-gun JapanRekrutierend» Google-MapsKyushu University Hospital 812-8582 Fukuoka-shi JapanRekrutierend» Google-MapsKurume University Hospital 830-0011 Kurume-shi JapanRekrutierend» Google-MapsFukushima Medical University Hospital 960-1295 Fukushima-shi JapanRekrutierend» Google-MapsSapporo Hokuyu Hospital 003-0006 Sapporo-shi JapanRekrutierend» Google-MapsKobe City Medical Center General Hospital 650-0047 Kobe-shi JapanRekrutierend» Google-MapsKanazawa University Hospital 920-8641 Kanazawa-shi JapanRekrutierend» Google-MapsTokai University Hospital 259-1193 Isehara-shi JapanRekrutierend» Google-MapsYokohama City University Medical Center 232-0024 Yokohama-shi JapanRekrutierend» Google-MapsNagasaki University Hospital 852-8501 Nagasaki-shi JapanRekrutierend» Google-MapsNational Hospital Organization Okayama Medical Center 701-1192 Okayama-shi JapanRekrutierend» Google-MapsOsaka Metropolitan University Hospital 545-8586 Osaka-shi JapanRekrutierend» Google-MapsKindai University Hospital 589-8511 Osakasayama-shi JapanRekrutierend» Google-MapsJichi Medical University Hospital 329-0498 Shimotsuke-shi JapanRekrutierend» Google-MapsYamagata University Hospital 990-9585 Yamagata-shi JapanRekrutierend» Google-MapsPusan National University Hospital 49241 Busan Korea, Republic ofRekrutierend» Google-MapsChonnam National University Hwasun Hospital 58128 Hwasun Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsThe Catholic University of Korea Seoul St Marys Hospital 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsBoca Clinical Trials Mexico SC 01120 Ciudad de Mexico MexicoRekrutierend» Google-MapsCentro Oncologico Internacional 01330 Mexico City MexicoRekrutierend» Google-MapsHospital Universitario Dr Jose Eleuterio Gonzalez 64460 Monterrey MexicoRekrutierend» Google-MapsHematologica Alta Especialidad 52787 Huixquilucan MexicoRekrutierend» Google-MapsUniversitair Medisch Centrum Groningen 9713 GZ Groningen NetherlandsRekrutierend» Google-MapsUnidade Local de Saude de Coimbra, EPE 3004-561 Coimbra PortugalRekrutierend» Google-MapsInstituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE 1099-023 Lisboa PortugalRekrutierend» Google-MapsUnidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos 1169-050 Lisboa PortugalRekrutierend» Google-MapsUnidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria 1649-035 Lisboa PortugalRekrutierend» Google-MapsInstitutul Clinic Fundeni 022328 Bucharest RomaniaRekrutierend» Google-MapsInstitutul Oncologic Prof Dr Ion Chiricuta 400015 Cluj-Napoca RomaniaRekrutierend» Google-MapsInstitutul Regional de Oncologie Iasi 700483 Iasi RomaniaRekrutierend» Google-MapsSpitalul Clinic Judetean de Urgenta Sibiu 550245 Sibiu RomaniaRekrutierend» Google-MapsHospital Universitario Reina Sofia 14004 Cordoba SpainRekrutierend» Google-MapsHospital Universitario Virgen del Rocio 41013 Sevilla SpainRekrutierend» Google-MapsHospital Universitario Marques de Valdecilla 39008 Santander SpainRekrutierend» Google-MapsComplejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca 37007 Salamanca SpainRekrutierend» Google-MapsInstitut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol 08916 Badalona SpainRekrutierend» Google-MapsHospital Universitari Vall d Hebron 08035 Barcelona SpainRekrutierend» Google-MapsInstitut Catala d Oncologia Hospitalet Hospital Duran i Reynals 08908 Hospitalet de Llobregat SpainRekrutierend» Google-MapsHospital Universitari i Politecnic La Fe 46026 Valencia SpainRekrutierend» Google-MapsSahlgrenska Universitetssjukhuset 413 45 Goteborg SwedenRekrutierend» Google-MapsInselspital Bern 3010 Bern SwitzerlandRekrutierend» Google-MapsChina Medical University Hospital 40458 Taichung TaiwanRekrutierend» Google-MapsTaichung Veterans General Hospital 40705 Taichung TaiwanRekrutierend» Google-MapsNational Cheng Kung University Hospital 70403 Tainan TaiwanRekrutierend» Google-MapsNational Taiwan University Hospital 10002 Taipei TaiwanRekrutierend» Google-MapsLinkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation 33305 Taoyuan TaiwanRekrutierend» Google-MapsHacettepe Universitesi Tip Fakultesi Hastanesi 06100 Ankara TurkeyRekrutierend» Google-MapsBagcilar Medipol Mega Universite Hastanesi 34214 Istanbul TurkeyRekrutierend» Google-MapsDokuz Eylul Universitesi Tip Fakultesi Hastanesi 35340 Izmir TurkeyRekrutierend» Google-MapsOndokuz Mayis Universitesi Tip Fakultesi Hastanesi 55139 Samsun TurkeyRekrutierend» Google-MapsUniversity College London NW1 2PG London United KingdomRekrutierend» Google-Maps
1. Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) (Time Frame - Up to approximately 5 years): Number and percentage of participants who experience one or more TEAE, serious TEAE,
treatment-related adverse events, and adverse events of interest.
2. Phase 3: Event-free Survival (EFS) (Time Frame - Up to approximately 5 years): Time from randomization (enrollment) until treatment failure, relapse or death from any
cause, whichever is earlier.
Treatment failure is defined as not achieving a hematological complete CR with MRD
response <10-4 by the end of the initial disease assessment period.
Relapse is defined as hematologic relapse, extramedullary relapse, and/or molecular
relapse (MRD positivity >= 10^-3), whichever occurs earlier, in participants with prior
achievement of hematologic CR with MRD response <10^-4.
Participants without an event will be censored at their last evaluable disease assessment
date.
3. Phase 3: Overall Survival (OS) (Time Frame - Up to approximately 5 years): OS is defined as time from randomization (enrollment) until death due to any cause.
Secondary outcome:
1. Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period (Time Frame - Baseline to Week 14)
2. Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period (Time Frame - Baseline to Week 14): MRD response is defined as the percentage of participants who achieve a response of <
10^-4 measured by polymerase chain reaction (PCR).
3. Safety run-in: Relapse-free Survival (RFS) (Time Frame - Up to approximately 5 years): RFS: In participants who achieve CR, the time from first achievement of this response
until date of the first relapse including hematologic relapse, extramedullary relapse, or
death due to any cause, whichever occurs first.
4. Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS) (Time Frame - Up to approximately 5 years): MRD RFS: In participants who achieve CR with MRD response, the time from first
achievement of this response until date of of the first relapse including molecular
relapse, hematological relapse, and/or extramedullary relapse, or death due to any cause,
whichever occurs first. (Molecular relapse will be defined 2 ways: MRD>= 10^-3 and
MRD>=10^-4. Participants without an event will be censored at their last evaluable
disease assessment date.
5. Safety run-in: Steady State Concentration (Css) of Blinatumomab (Time Frame - Up to approximately 34 weeks)
6. Safety run-in: Clearance (CL) of Blinatumomab (Time Frame - Up to approximately 34 weeks)
7. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score (Time Frame - Baseline to Week 14): Fatigue score will be measured by Patient-Reported Outcomes Measurement Information
System (PROMIS) Fatigue - Short Form 7a.
8. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Pain Score (Time Frame - Baseline to Week 14): Pain score will be measured by Brief Pain Inventory - Short Form (BPI-SF); Item 3: pain
at its worst in the last 24 hours.
9. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status (Time Frame - Baseline to Week 14): Global health status will be measured by the Quality of Life Questionnaire (QLQ)-C30
global health status quality of life scale.
10. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Physical Function (Time Frame - Baseline to Week 14): Physical function will be measured by the QLQ-C30 functional scale.
11. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Nausea and Vomiting (Time Frame - Baseline to Week 14): Nausea and vomiting will be measured by the QLQ-C30 symptom scale.
12. Phase 3: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period (Time Frame - Baseline to Week 14)
13. Phase 3: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period (Time Frame - Baseline to Week 14): MRD response is defined as the percentage of participants who achieve a response of <
10^4 measured by polymerase chain reaction (PCR).
14. Phase 3: Relapse-free Survival (RFS) (Time Frame - Up to approximately 5 years): RFS: In participants who achieve CR, the time from first achievement of this response
until the date of the first relapse including hematologic relapse, extra medullary
relapse, or death due to any cause, whichever occurs first. Participants without an event
will be censored at their last evaluable disease assessment date.
15. Phase 3: Minimal Residual Disease (MRD) Relapse Free Survival (RFS) (Time Frame - Up to approximately 5 years): In participants who achieve CR with MRD response, the time from first achievement of this
response until date of the first relapse including molecular relapse, hematologic
relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs
first. Molecular relapse will be defined 2 ways: MRD>= 10^-3 and MRD>= 10^-4.
Participants without an event will be censored at their last evaluable disease assessment
date
16. Phase 3: Minimal Residual Disease (MRD) Over Time (Time Frame - Up to approximately 5 years)
17. Phase 3: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) (Time Frame - Up to approximately 5 years): Number and percentage of participants who experience one or more TEAE, serious TEAE,
treatment-related adverse events, and adverse events of interest.
18. Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse by Flow Cytometry for Bone Marrow (Time Frame - Up to approximately 5 years)
19. Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse Identified by Immunohistochemistry or Flow Cytometry for Cerebrospinal Fluid (Time Frame - Up to end of safety follow up (approximately 44 months))
20. Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse for Extramedullary Sites other than Cerebrospinal Fluid (Time Frame - Up to end of safety follow up (approximately 44 months))
21. Phase 3: Rate of Lineage Switch to Acute Myeloid Leukemia (AML) (Time Frame - Up to end of safety follow up (approximately 44 months))
22. Phase 3: Localization of Relapse by Clinical Assessment (Time Frame - Up to end of safety follow up (approximately 44 months))
23. Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) (Time Frame - Up to approximately 5 years)
24. Phase 3: Number of Participants who have Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Participants who Experience Continuous First Complete Remission (CR) (Time Frame - Up to approximately 5 years)
25. Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) (Time Frame - Up to approximately 5 years)
26. Phase 3: Relapse Rate Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) (Time Frame - Up to approximately 5 years)
27. Phase 3: Time to Deterioration using the Fatigue Score (Time Frame - Up to approximately 5 years): Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
28. Phase 3: Time to Improvements using the Fatigue Score (Time Frame - Up to approximately 5 years): Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
29. Phase 3: Time to Deterioration using the Pain Score (Time Frame - Up to approximately 5 years): Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
30. Phase 3: Time to Improvements using the Pain Score (Time Frame - Up to approximately 5 years): Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
31. Phase 3: Change from Baseline in Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Baseline to end of study (up to approximately 5 years)): EORTC QLQ-C30 will include global health status, physical functioning, emotional
functioning, cognitive functioning, nausea/vomiting, pain, dyspnea, insomnia, appetite
loss, diarrhea, and financial difficulties will be measured by EORTC QLQ-C30.
32. Phase 3: Time to Deterioration for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Up to approximately 5 years): Global health status, physical functioning, role functioning, emotional functioning,
cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea,
insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC
QCQ-C30.
33. Phase 3: Time to Improvements for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Up to approximately 5 years): Global health status, physical functioning, role functioning, emotional functioning,
cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea,
insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC
QCQ-C30.
Experimental: Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy The safety run-in will be performed prior to initiating the phase 3 randomized part of
the study. This safety run-in is to evaluate the safety and tolerability of blinatumomab
alternating with low-intensity chemotherapy.
The safety run-in also evaluates a shorter dose step interval from (4 days instead of 7
days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles.
Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on
Day 5 of the infusion for the remainder of the infusion.
Experimental: Phase 3: Blinatumomab alternating with low-intensity chemotherapy Participants will receive blinatumomab alternating with low-intensity chemotherapy.
Active Comparator: Phase 3: Standard of care (SOC) chemotherapy Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per
investigator's choice.
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"Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia"
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