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NCT03374332 · ClinicalTrials.gov registry record · Phase 2

Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

A Phase 2 study of Acute Myeloid Leukemia, sponsored by Brown University.

Active
Registry status
Phase 2
Development phase
11
Enrollment target
1
Study location

NCT03374332 is a Phase 2 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Brown University. The registered enrollment target is 11 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03374332, a Phase 2 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Brown University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
11 participants
Enrollment target
1
Study location

Study Summary

This study includes patients with relapsed acute leukemia who have previously been treated with standard treatment that is still present and there is no curative treatment option available. Researchers are studying whether the drug Gemtuzumab Ozogamicin, followed by an infusion of blood cells called leukocytes from a donor, can stimulate the immune system to potentially fight the leukemia. Gemtuzmab ozogamicin is a class of drugs known as an antibody drug conjugate. The drug is given on days 1,4,7. It is infused, attaches to cells with a certain marker on the surface (the majority of which would be leukemia cells). The drug is then internalized and the chemotherapy drug becomes activated. Gemtuzumab is currently FDA approved for the treatment of acute myeloid leukemia. The infusion of leukocytes to stimulate the immune system to fight your leukemia is investigational and has not been proven to cure cancer. This combination of Gemtuzumab Ozogamicin and donor leukocytes is not an FDA approved treatment and is investigational. Initially a total of 6 patients will be included in the study to assess the safety of the treatment. Once 6 patients have been treated and no unacceptable toxicities are seen, more patients will be enrolled. The study will treat up to 18 patients on the study.

Conditions Studied

Acute Myeloid Leukemia

Interventions

  • DRUG Gemtuzumab Ozogamicin (GO)
  • OTHER Donor Leukocytes

Study Locations (1)

Rhode Island

  • Rhode Island Hospital - Providence

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2019-12-31
Est. Completion 2024-09
Phase Phase 2

Sponsor

Brown University

231 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03374332

The ClinicalTrials.gov registry entry for NCT03374332 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (91% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Gemtuzumab Ozogamicin (GO) is the first listed.

NCT03374332 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.

Frequently Asked Questions

What is clinical trial NCT03374332 about?

NCT03374332 is a clinical study titled "Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia". This study includes patients with relapsed acute leukemia who have previously been treated with standard treatment that is still present and there is no curative treatment option available. Researchers are studying whether the drug Gemtuzumab Ozogamicin, followed by an infusion of blood cells called...

What is the current status of trial NCT03374332?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2019-12-31. Estimated completion is 2024-09.

What conditions does trial NCT03374332 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia.

What interventions are being tested in trial NCT03374332?

The interventions under investigation include: Gemtuzumab Ozogamicin (GO) (DRUG), Donor Leukocytes (OTHER).

Who is sponsoring clinical trial NCT03374332?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03374332 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.