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NCT03677596 · ClinicalTrials.gov registry record · Phase 4

A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients

A Phase 4 study, sponsored by Pfizer.

Completed
Registry status
Phase 4
Development phase
102
Enrollment target

NCT03677596 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 102 participants.

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The verdict

NCT03677596, a Phase 4 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 4
Development phase
102 participants
Enrollment target

Study Summary

This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refractory ALL who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be evaluated.

Interventions

  • DRUG inotuzumab ozogamicin-dose level 2
  • DRUG Inotuzumab ozogamicin-dose level 1

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2019-07-01
Est. Completion 2023-05-26
Phase Phase 4

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT03677596

The ClinicalTrials.gov registry entry for NCT03677596 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which inotuzumab ozogamicin-dose level 2 is the first listed.

NCT03677596 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03677596 about?

NCT03677596 is a clinical study titled "A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients". This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refrac...

What is the current status of trial NCT03677596?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2019-07-01. Estimated completion is 2023-05-26.

What interventions are being tested in trial NCT03677596?

The interventions under investigation include: inotuzumab ozogamicin-dose level 2 (DRUG), Inotuzumab ozogamicin-dose level 1 (DRUG).

Who is sponsoring clinical trial NCT03677596?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.