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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: Active Phase 1 study of Myelodysplastic Syndromes, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Maximum tolerated Dose will be determined by testing increasing doses of canakinumab along with a fixed dose of darbepoetin alfa. Patients will be followed for at least 1 cycle before the safety of each cohort can be fully assessed and decisions made for dose escalation in the next cohort. The MTD is defined as the dose level below which DLT is manifested in ≥33% of the patients or at dose level 2 if DLT is manifested in \<33% of the patients (with at 6 patients treated at the MTD).
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
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-03-30 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What the registry record for NCT04798339 still lists
NCT04798339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04798339's enrollment target sits among peer trials
13 158th of 173 higher than 15 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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.
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