Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

February 16, 2015

Primary Completion Date

June 28, 2024

Study Completion Date

June 28, 2024

Conditions
Acute Lymphoblastic Leukemia (ALL)
Interventions
DRUG

Carfilzomib

DRUG

Dexamethasone

DRUG

Mitoxantrone

DRUG

PEG-asparaginase

DRUG

Vincristine

DRUG

Intrathecal (IT) Methotrexate

DRUG

Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)

DRUG

6-Mercaptopurine

DRUG

Cyclophosphamide

DRUG

Cytarabine

DRUG

Daunorubicin

Trial Locations (122)

1090

St Anna Kinderspital, Vienna

1527

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL EAD, Sofia

1864

Chris Hani Baragwanath Hospital, Johannesburg

2031

Sydney Childrens Hospital, Randwick

2100

University Hospital Rigshospitalet, København Ø

2145

The Childrens Hospital at Westmead, Westmead

3052

The Royal Childrens Hospital, Parkville

4101

Queensland Childrens Hospital, South Brisbane

6909

Perth Childrens Hospital, Nedlands

10032

Childrens Hospital of New York Presbyterian, New York

10041

National Taiwan University Hospital, Taipei

10126

Azienda Ospedaliera Citta della Salute e della Scienza Torino Ospedale Infantile Regina Margherita, Torino

10330

King Chulalongkorn Memorial Hospital, Bangkok

10400

Phramongkutklao Hospital, Bangkok

Ramathibodi Hospital, Bangkok

10449

Mackay Memorial Hospital Taipei Branch, Taipei

10700

Siriraj Hospital, Bangkok

11525

King Fahad Medical City, Riyadh

11527

Agia Sofia Children Hospital, Athens

Agia Sofia Children Hospital, Goudi

General Children Hospital Panagioti and Aglaias Kyriakou, Goudi

16059

Bursa Uludag Universitesi Tip Fakultesi, Bursa

16147

IRCCS Istituto Giannina Gaslini, Genova

20900

Fondazione IRCCS San Gerardo dei Tintori, Monza (MB)

21231

The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore

26504

General University Hospital of Patras Panagia i Voithia, Pátrai

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28009

Hospital Universitario Infantil Niño Jesus, Madrid

28046

Hospital Universitario La Paz, Madrid

28203

Levine Childrens Hospital at Carolinas Medical Center d/b/a Atrium Health, Charlotte

30322

Childrens Healthcare of Atlanta, Egleston, Atlanta

31059

Centre Hospitalier Universitaire de Toulouse - Hopital des enfants, Toulouse

33076

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin, Bordeaux

33305

Linkou Chang Gung Memorial Hospital, Taoyuan District

34160

Medical Park Bahcelievler Hastanesi, Istanbul

34214

Medipol Mega Universite Hastanesi, Istanbul

35040

Ege Universitesi Tip Fakultesi, Izmir

35128

Azienda Ospedaliera di Padova, Padua

38039

Erciyes Universitesi Tip Fakultesi Mustafa Eraslan ve Fevzi Mercan Cocuk Hastanesi, Kayseri

38105

Saint Judes Childrens Research Hospital, Memphis

43205

Nationwide Childrens Hospital, Columbus

44195

The Cleveland Clinic Foundation, Cleveland

44600

BRCR Global Mexico, Guadalajara

45229

Cincinnati Childrens Hospital Medical Center, Cincinnati

50612

Pusan National University Yangsan Hospital, Yangsan-si, Gyeongsangnam-do

53226

Medical College of Wisconsin, Milwaukee

54511

Centre Hospitalier Universitaire de Nancy - Hopital Enfants de Brabois, Vandœuvre-lès-Nancy

54642

Ippokrateio General Hospital of Thessaloniki, Thessaloniki

55404

Childrens Hospital and Clinics of Minnesota, Minneapolis

59037

Centre Hospitalier Regional Universitaire de Lille, Lille

60611

Lurie Childrens Hospital of Chicago, Chicago

60637

West Virginia University Medicine Childrens, Morgantown

64108

Childrens Mercy Hospital, Kansas City

70124

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari

72160

BRCR Global Mexico, Puebla City

75012

Hopital Armand Trousseau, Paris

75019

Hopital Robert Debre, Paris

75390

Childrens Medical Center, Dallas

77030

Texas Childrens Hospital West Tower, Houston

80045

Childrens Hospital Colorado, Aurora

80123

Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon, Napoli

84113

University of Utah Medical Center Primary Childrens Medical Center, Salt Lake City

92868

Childrens Hospital of Orange County, Orange

94609

University of California San Francisco Benioff Childrens Hospital Oakland, Oakland

95123

Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico, Catania

115478

FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation, Moscow

117198

FSBI FSCC of pediatric hematology, oncology and immunology n a Dmitry Rogachev, Moscow

119228

National University Hospital, Singapore

197022

SBEI of HPE Saint Petersburg State Medical University na academic I P Pavlov of MoH of RF, Saint Petersburg

200001

Sociedad de Oncologia y Hematologia del Cesar, Valledupar

229899

KK Womens and Childrens Hospital, Singapore

300011

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara, Timișoara

400015

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj-Napoca

760042

Clinica Imbanaco S.A.S, Santiago de Cali

5262000

Sheba Medical Center, Tel Litwinsky

7500539

Hospital Luis Calvo Mackenna, Santiago

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

19104-4318

Childrens Hospital of Philadelphia, Philadelphia

78229-4493

University of Texas Health Science Center at San Antonio, San Antonio

C1118AAT

Hospital Aleman, Ciudad Autonoma de Buenos Aires

C1199

Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires

B1629ODT

Hospital Universitario Austral, Pilar

41253-190

Hospital São Rafael - IDOR, Salvador

70684-831

Hospital da Crianca de Brasília, Brasília

81520-060

Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner, Curitba

80250-060

Hospital Pequeno Principe, Curitiba

50070-550

Instituto de Medicina Integral Professor Fernando Figueira, Recife

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

90050-170

Hospital da Crianca Santo Antonio Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

14784-400

Fundacao Pio 12 Hospital de Amor de Barretos, Barretos

14040-900

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo, Ribeirão Preto

05403-000

Itaci Instituto de Tratamento do Cancer Infantil, São Paulo

01323-001

Beneficencia Portuguesa de Sao Paulo, São Paulo

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

Unknown

Hospital Roberto del Rio, Santiago

Hong Kong Childrens Hospital, Kowloon Bay

613 00

Fakultni nemocnice Brno, Brno

00165

IRCCS Ospedale Pediatrico Bambino Gesu, Roma

01120

BRCR Global Mexico, Mexico City

04530

Instituto Nacional de Pediatria, Mexico City

3584 CS

Prinses Maxima Centrum voor Kinderoncologie, Utrecht

0372

Oslo Universitetssykehus Rikshospitalet, Oslo

30-663

Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow

91-738

CSK Uniwersytetu Medycznego w Lodzi Uniwersyteckie Centrum Pediatrii im Marii Konopnickiej, Lodz

20-093

Uniwersytecki szpital dzieciecy, Lublin

02-091

Uck wum dzieciecy szpital kliniczny im jozefa polikarpa brudzinskiego, Warsaw

50-556

Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw

41-800

SPSK nr 1 im Prof Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach, Zabrze

3000-602

Centro Hospitalar Universitario de Coimbra, Coimbra

1099-023

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE, Lisbon

4200-072

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE, Porto

022328

Institutul Clinic Fundeni, Bucharest

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

171 76

Karolinska Universitetssjukhuset Solna, Solna

01130

Acibadem Adana Hastanesi, Adana

06590

Ankara Universitesi Tip Fakultesi Hastanesi, Ankara

06800

Ankara Bilkent Sehir Hastanesi, Ankara

07230

Medical Park Antalya Hastanesi, Antalya

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator

UNKNOWN

collaborator

Innovative Therapies For Children with Cancer Consortium

OTHER

lead

Amgen

INDUSTRY