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NCT03384654 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Precursor Cell Lymphoblastic Leukemia-Lymphoma, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 20
- Study locations
NCT03384654 is a Phase 2 study of Precursor Cell Lymphoblastic Leukemia-Lymphoma that has completed, run by Janssen Research & Development. The registered enrollment target is 47 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT03384654, a Phase 2 study of Precursor Cell Lymphoblastic Leukemia-Lymphoma, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Prednisone
- DRUG Daratumumab
- BIOLOGICAL Peg-asparaginase
Study Locations (20)
California
- UCSF Benioff Children's Hospital Oakland - Oakland
- Children's Hospital Orange County - Orange
- Stanford University - Palo Alto
New York
- New York University Langone Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- Stony Brook University Medical Center - Stony Brook
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Georgia
- Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2018-05-14 |
| Est. Completion | 2022-09-27 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03384654
The ClinicalTrials.gov registry entry for NCT03384654 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Precursor Cell Lymphoblastic Leukemia-Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.
NCT03384654 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT03384654 about?
NCT03384654 is a clinical study titled "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". 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.
What is the current status of trial NCT03384654?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2018-05-14. Estimated completion is 2022-09-27.
What conditions does trial NCT03384654 study?
This clinical trial studies the following conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma.
What interventions are being tested in trial NCT03384654?
The interventions under investigation include: Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG), Daratumumab (DRUG), Peg-asparaginase (BIOLOGICAL).
Who is sponsoring clinical trial NCT03384654?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03384654 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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