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NCT04838041 · ClinicalTrials.gov registry record · Phase 2
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
A Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 4
- Study locations
NCT04838041: Recruiting Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, sponsored by Medical College of Wisconsin.
NCT04838041 is a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 51 participants, roughly in line with the 53-participant average among 9 other Chronic Phase Chronic Myelogenous Leukemia trials with a reported enrollment target. The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04838041, a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.
Primary Outcome
This will be measured by the number of subjects who achieve one-year treatment-free remission after 12 months of asciminib based therapy. These subjects have previously failed a first treatment free remission attempt.
Conditions Studied
Interventions
- DRUG Nilotinib
- DRUG Imatinib
- DRUG Asciminib 40 MG
- DRUG Asciminib 40 MG Twice Daily
- DRUG Asciminib 80 MG daily
Study Locations (4)
Michigan
- The Barbara Ann Karmanos Cancer Institute - Detroit
New York
- Memorial Sloan Kettering Cancer Center - New York
Utah
- Huntsman Cancer Institute - Salt Lake City
Wisconsin
- Froedtert Hospital & the Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-11-11 |
| Est. Completion | 2029-07 |
| Phase | Phase 2 |
What NCT04838041 shows while recruiting
NCT04838041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, roughly in line with the 53-participant average among 9 other Chronic Phase Chronic Myelogenous Leukemia trials with a reported enrollment target.
The record links to 1 condition, with Chronic Phase Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Nilotinib is the first listed.
NCT04838041 reports a single indexed study location in Michigan, New York, Utah.
Frequently Asked Questions
What is clinical trial NCT04838041 about?
NCT04838041 is a clinical study titled "Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation". This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restar...
What is the current status of trial NCT04838041?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-11-11. Estimated completion is 2029-07.
What conditions does trial NCT04838041 study?
This clinical trial studies the following conditions: Chronic Phase Chronic Myelogenous Leukemia.
What interventions are being tested in trial NCT04838041?
The interventions under investigation include: Nilotinib (DRUG), Imatinib (DRUG), Asciminib 40 MG (DRUG), Asciminib 40 MG Twice Daily (DRUG), Asciminib 80 MG daily (DRUG).
Who is sponsoring clinical trial NCT04838041?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04838041 being conducted?
This trial has 4 study locations across Michigan, New York, Utah, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04838041's enrollment target sits among peer trials
51 5th of 9 higher than 5 of 9 other Chronic Phase Chronic Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Phase Chronic Myelogenous Leukemia 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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