A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

May 14, 2018

Primary Completion Date

September 22, 2022

Study Completion Date

September 27, 2022

Conditions
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Interventions
DRUG

Daratumumab

Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.

DRUG

Vincristine

Participant will receive vincristine 1.5 milligram per meter square (mg/m\^2) in cohort 1 and cohort 2.

DRUG

Prednisone

Participant will receive prednisone 40 mg/m\^2 in cohort 1 and cohort 2.

DRUG

Doxorubicin

Participant will receive doxorubicin 60 mg/m\^2 in cohort 2.

BIOLOGICAL

Peg-asparaginase

Participant will receive peg-asparaginase 2500 units per meter square (U/m\^2) in cohort 2.

DRUG

Cyclophosphamide

Participant will receive cyclophosphamide 1 gram per meter square (g/m\^2) once in cohort 2.

DRUG

Cytarabine

Participant will receive cytarabine 75 mg/m\^2 in cohort 2.

DRUG

6-mercaptopurine

Participant will receive 6-mercaptopurine 60 mg/m\^2 orally daily in cohort 2.

DRUG

Methotrexate

Participant will receive methotrexate 5 g/m\^2 intravenously (IV) in cohort 2.

Trial Locations (53)

8035

Hosp Univ Vall D Hebron, Barcelona

9000

Universitair Ziekenhuis Gent - UZ GENT, Ghent

10016

New York University Langone Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10126

AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita, Torino

11733

Stony Brook University Medical Center, Stony Brook

13353

Charite-Universitätsmedizin Berlin - Berlin, Berlin

16147

Istituto Giannina Gaslini, Genova

17176

Karolinska University Hospital, Stockholm

19104

Children's Hospital of Philadelphia, Philadelphia

20900

Fondazione MBBM, ASST Monza, Monza

28009

Hosp. Infantil Univ. Nino Jesus, Madrid

30342

Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

33076

CHU de Bordeaux, Hopital des Enfants, Bordeaux

43214

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46026

Hosp. Univ. I Politecni La Fe, Valencia

46202

Riley Hospital for Children, Indianapolis

48149

Universitatsklinikum Munster, Münster

54500

Hôpital D'Enfants, Vandœuvre-lès-Nancy

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

Washington Univeristy School of Medicine/ Pediatrics, St Louis

69008

IHOPE - Hospices civils de Lyon, Lyon

75012

Hopital trousseau- APHP, Paris

75019

Hôpital Robert Debré, Paris

75235

UT Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

78723

Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center, Austin

80045

Children's Hospital Colorado, Aurora

84113

University of Utah Primary Children's Medical Center, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

92868

Children's Hospital Orange County, Orange

94304

Stanford University, Palo Alto

94609

UCSF Benioff Children's Hospital Oakland, Oakland

4920235

Schneider Children's Medical Center, Petach Tiquva

35233-1711

University of Alabama at Birmingham, Birmingham

06106

Connecticut Children's Medical Center, Hartford

21231-1000

Johns Hopkins University, Baltimore

02215-5418

Dana Farber Cancer Institute, Boston

48109-4257

C.S. Mott Children's Hospital, Ann Arbor

07112

Newark Beth Israel Medical Center, Newark

53226-3522

Medical College Of Wisconsin, Milwaukee

00165

Ospedale Pediatrico Bambin Gesù, Roma

3584 EA

Princess Maxima Center, Utrecht

08950

Hosp. Sant Joan de Deu, Esplugues de Llobregat

BS2 8BJ

Bristol Royal Hospital for Children, Bristol

G51 4TF

Royal Hospital for Sick Children, Glasgow

LS1 3EX

Leeds Children's Hospital, Leeds

NW1 2BU

University College London Hospitals, London

WC1N 2JH

Great Ormond Street Hospital, London

M13 9WL

Royal Manchester Children's Hospital, Manchester

SM2 5PT

Royal Marsden Hospital, Surrey

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03384654 - A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma | Biotech Hunter | Biotech Hunter