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COMPLETED 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

NCT03384654 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 47 participants
Start Date 2018-05-14
Est. Completion 2022-09-27
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03384654 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03384654?

The interventions under investigation include: Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG), Daratumumab (DRUG), Peg-asparaginase (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03384654?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial