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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03384654

Public ClinicalTrials.gov record NCT03384654. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 16, 2026, 4:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Study identification

NCT ID
NCT03384654
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
47 participants

Conditions and interventions

Interventions

  • 6-mercaptopurine Drug
  • Cyclophosphamide Drug
  • Cytarabine Drug
  • Daratumumab Drug
  • Doxorubicin Drug
  • Methotrexate Drug
  • Peg-asparaginase Biological
  • Prednisone Drug
  • Vincristine Drug

Drug · Biological

Eligibility (public fields only)

Age range
1 Year to 30 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 13, 2018
Primary completion
Sep 21, 2022
Completion
Sep 26, 2022
Last update posted
May 24, 2025

2018 – 2022

United States locations

U.S. sites
26
U.S. states
19
U.S. cities
25
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233-1711
Phoenix Children's Hospital Phoenix Arizona 85016
UCSF Benioff Children's Hospital Oakland Oakland California 94609
Children's Hospital Orange County Orange California 92868
Stanford University Palo Alto California 94304
Children's Hospital Colorado Aurora Colorado 80045
Connecticut Children's Medical Center Hartford Connecticut 06106
Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics Atlanta Georgia 30342
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611
Riley Hospital for Children Indianapolis Indiana 46202
Johns Hopkins University Baltimore Maryland 21231-1000
Dana Farber Cancer Institute Boston Massachusetts 02215-5418
C.S. Mott Children's Hospital Ann Arbor Michigan 48109-4257
Washington Univeristy School of Medicine/ Pediatrics St Louis Missouri 63110
Newark Beth Israel Medical Center Newark New Jersey 07112
New York University Langone Medical Center New York New York 10016
Memorial Sloan Kettering Cancer Center New York New York 10065
Stony Brook University Medical Center Stony Brook New York 11733
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Nationwide Children's Hospital Columbus Ohio 43214
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center Austin Texas 78723
UT Southwestern Medical Center Dallas Texas 75235
Baylor College of Medicine Houston Texas 77030
University of Utah Primary Children's Medical Center Salt Lake City Utah 84113
Medical College Of Wisconsin Milwaukee Wisconsin 53226-3522

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03384654, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 24, 2025 · Synced May 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03384654 live on ClinicalTrials.gov.

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