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NCT04207190 · ClinicalTrials.gov registry record · Phase 1

Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT04207190 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 24 participants.

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The verdict

NCT04207190, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This phase I/Ib trial studies the side effects and best dose of talazoparib given together with gemtuzumab ozogamicin and to see how well they work in treating patients with CD33 positive acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Gemtuzumab ozogamicin is a protein (antibody) combined with a chemotherapy drug which specifically targets acute myeloid leukemia cells expressing a marker (CD33). Adding talazoparib to the gemtuzumab ozogamicin therapy may lead to an increased effectiveness in treatment.

Interventions

  • OTHER Quality-of-Life Assessment
  • DRUG Gemtuzumab Ozogamicin
  • OTHER Questionnaire Administration
  • DRUG Talazoparib
  • DRUG Talazoparib Tosylate

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-10-23
Est. Completion 2024-06-29
Phase Phase 1

Sponsor

Roswell Park Cancer Institute

365 total trials

What the Registry Record Tells You About NCT04207190

The ClinicalTrials.gov registry entry for NCT04207190 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT04207190 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04207190 about?

NCT04207190 is a clinical study titled "Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia". This phase I/Ib trial studies the side effects and best dose of talazoparib given together with gemtuzumab ozogamicin and to see how well they work in treating patients with CD33 positive acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Talazoparib ...

What is the current status of trial NCT04207190?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-10-23. Estimated completion is 2024-06-29.

What interventions are being tested in trial NCT04207190?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Gemtuzumab Ozogamicin (DRUG), Questionnaire Administration (OTHER), Talazoparib (DRUG), Talazoparib Tosylate (DRUG).

Who is sponsoring clinical trial NCT04207190?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 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.