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NCT04798339 · ClinicalTrials.gov registry record · Phase 1

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA

A Phase 1 study of Myelodysplastic Syndromes, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Active
Registry status
Phase 1
Development phase
13
Enrollment target
2
Study locations

NCT04798339 is a Phase 1 study of Myelodysplastic Syndromes that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 13 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04798339, a Phase 1 study of Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
13 participants
Enrollment target
2
Study locations

Study Summary

This study is a multi-institution, open-label, Phase 1b/2 clinical trial evaluating the toxicity and efficacy of canakinumab in combination with darbepoetin alfa in patients with lower-risk MDS who have failed prior treatment with an Erythropoietin Stimulating Agent (ESA)

Conditions Studied

Interventions

  • DRUG Darbepoetin Alfa
  • DRUG Canakinumab Injection

Study Locations (2)

Florida

  • Moffitt Cancer Center - Tampa

Georgia

  • Emory-Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-03-30
Est. Completion 2026-07
Phase Phase 1

What the Registry Record Tells You About NCT04798339

The ClinicalTrials.gov registry entry for NCT04798339 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Darbepoetin Alfa is the first listed.

NCT04798339 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT04798339 about?

NCT04798339 is a clinical study titled "Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA". This study is a multi-institution, open-label, Phase 1b/2 clinical trial evaluating the toxicity and efficacy of canakinumab in combination with darbepoetin alfa in patients with lower-risk MDS who have failed prior treatment with an Erythropoietin Stimulating Agent (ESA)

What is the current status of trial NCT04798339?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-03-30. Estimated completion is 2026-07.

What conditions does trial NCT04798339 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes.

What interventions are being tested in trial NCT04798339?

The interventions under investigation include: Darbepoetin Alfa (DRUG), Canakinumab Injection (DRUG).

Who is sponsoring clinical trial NCT04798339?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04798339 being conducted?

This trial has 2 study locations across Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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