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NCT02454270 · ClinicalTrials.gov registry record · Phase 1

A Dose Escalation Study of Duvortuxizumab in Participants With Relapsed or Refractory B-cell Malignancies

A Phase 1 study, sponsored by Janssen Research & Development.

Terminated
Registry status
Phase 1
Development phase
59
Enrollment target

NCT02454270: Clinical Trial Phase 1 study, sponsored by Janssen Research & Development.

NCT02454270 is a Phase 1 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02454270, a Phase 1 study, was terminated before completion, sponsored by Janssen Research & Development.

TERMINATED
Registry status
Phase 1
Development phase
59 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to participants with relapsed or refractory B-cell malignancies \[diffuse-large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL)\].

Primary Outcome

The RP2D will be determined based on safety, clinical activity, pharmacokinetics, and pharmacodynamics in participants with relapsed or refractory B cell malignancies \[diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL)\].

Interventions

  • DRUG Part 1 (Dose Escalation): Duvortuxizumab
  • DRUG Part 2 (Dose Expansion): Duvortuxizumab

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2015-06-15
Est. Completion 2018-07-26
Phase Phase 1
Janssen Research & Development

593 total trials

Why NCT02454270 stopped before completion

NCT02454270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Part 1 (Dose Escalation): Duvortuxizumab is the first listed.

NCT02454270 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02454270 about?

NCT02454270 is a clinical study titled "A Dose Escalation Study of Duvortuxizumab in Participants With Relapsed or Refractory B-cell Malignancies". The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to participants with rel...

What is the current status of trial NCT02454270?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2015-06-15. Estimated completion is 2018-07-26.

What interventions are being tested in trial NCT02454270?

The interventions under investigation include: Part 1 (Dose Escalation): Duvortuxizumab (DRUG), Part 2 (Dose Expansion): Duvortuxizumab (DRUG).

Who is sponsoring clinical trial NCT02454270?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02454270's enrollment target sits among peer trials

59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02454270, the US trial registry maintained by the National Library of Medicine. NCT02454270 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.