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
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.
Study identification
- NCT ID
- NCT03384654
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 47 participants
Conditions and interventions
Interventions
- Daratumumab Drug
- Vincristine Drug
- Prednisone Drug
- Doxorubicin Drug
- Peg-asparaginase Biological
- Cyclophosphamide Drug
- Cytarabine Drug
- 6-mercaptopurine Drug
- Methotrexate 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 14, 2018 (Actual)
- Primary completion
- Sep 22, 2022 (Actual)
- Completion
- Sep 27, 2022 (Actual)
- Last update posted
- May 25, 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 25, 2025 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03384654 live on ClinicalTrials.gov.