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NCT03570892 · ClinicalTrials.gov registry record · Phase 3

Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
330
Enrollment target

NCT03570892: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT03570892 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 330 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03570892, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
330 participants
Enrollment target

Study Summary

This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.

Primary Outcome

Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 (+/- 1 week) assessment, as assessed by Blinded Independent Review Committee (BIRC) per Lugano criteria, or death due to any cause, at any time.

Interventions

  • DRUG Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy
  • DRUG Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2019-05-09
Est. Completion 2026-02-03
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT03570892 record still lists

NCT03570892 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 2 interventions - of which Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy is the first listed.

NCT03570892 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03570892 about?

NCT03570892 is a clinical study titled "Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma". This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.

What is the current status of trial NCT03570892?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2019-05-09. Estimated completion is 2026-02-03.

What interventions are being tested in trial NCT03570892?

The interventions under investigation include: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy (DRUG), Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT) (DRUG).

Who is sponsoring clinical trial NCT03570892?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03570892's enrollment target sits among peer trials

330 1066th of 2000 higher than 927 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT03570892, the US trial registry maintained by the National Library of Medicine. NCT03570892 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.