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NCT04239157 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
A Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT04239157: Recruiting Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT04239157 is a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 76 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04239157, a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well canakinumab works for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Canakinumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Primary Outcome
Will be monitored simultaneously using the Bayesian approach of Thall, Simon, Estey. Will estimate the HI rate for canakinumab, along with the 95% credible intervals. The association between HI rate and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test.
Conditions Studied
Interventions
- BIOLOGICAL Canakinumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04239157 shows while recruiting
NCT04239157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (63% lower).
The record links to 6 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Canakinumab is the first listed.
NCT04239157 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04239157 about?
NCT04239157 is a clinical study titled "A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia". This phase II trial studies how well canakinumab works for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Canakinumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
What is the current status of trial NCT04239157?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2020-08-25. Estimated completion is 2026-12-31.
What conditions does trial NCT04239157 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, Recurrent Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT04239157?
The interventions under investigation include: Canakinumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04239157?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04239157 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04239157's enrollment target sits among peer trials
76 45th of 134 higher than 90 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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