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NCT04877522 · ClinicalTrials.gov registry record · Phase 4
Asciminib Roll-over Study
A Phase 4 study of Chronic Myelogenous Leukemia and Leukemia, Myelogenous, Chronic, BCR-ABL Positive, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 347
- Enrollment target
- 20
- Study locations
NCT04877522: Recruiting Phase 4 study of Chronic Myelogenous Leukemia and Leukemia, Myelogenous, Chronic, BCR-ABL Positive, sponsored by Novartis Pharmaceuticals.
NCT04877522 is a Phase 4 study of Chronic Myelogenous Leukemia and Leukemia, Myelogenous, Chronic, BCR-ABL Positive that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 347 participants, above the 271-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04877522, a Phase 4 study of Chronic Myelogenous Leukemia and Leukemia, Myelogenous, Chronic, BCR-ABL Positive, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 347 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
Primary Outcome
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
Conditions Studied
Interventions
- DRUG Dasatinib
- DRUG Bosutinib
- DRUG Nilotinib
- DRUG Asciminib single agent
- DRUG Imatinib
Study Locations (20)
Other
- Novartis Investigative Site - Capital Federal
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Varna
Texas
- Texas Oncology - Dallas
- Uni Of TX MD Anderson Cancer Cntr - Houston
São Paulo
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
Michigan
- Michigan Med University of Michigan - Ann Arbor
New York
- Memorial Sloan Kettering - New York
Oregon
- Oregon Health Sciences University - Portland
Buenos Aires
- Novartis Investigative Site - CABA
Rio de Janeiro
- Novartis Investigative Site - Rio de Janeiro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2022-08-30 |
| Est. Completion | 2030-08-30 |
| Phase | Phase 4 |
What NCT04877522 shows while recruiting
NCT04877522 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, above the 271-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (28% higher).
The record links to 2 conditions, with Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Dasatinib is the first listed.
NCT04877522 names 20 study sites across 15 states, led by Other, Texas, São Paulo.
Frequently Asked Questions
What is clinical trial NCT04877522 about?
NCT04877522 is a clinical study titled "Asciminib Roll-over Study". This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
What is the current status of trial NCT04877522?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 347 participants. The study started on 2022-08-30. Estimated completion is 2030-08-30.
What conditions does trial NCT04877522 study?
This clinical trial studies the following conditions: Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
What interventions are being tested in trial NCT04877522?
The interventions under investigation include: Dasatinib (DRUG), Bosutinib (DRUG), Nilotinib (DRUG), Asciminib single agent (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT04877522?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04877522 being conducted?
This trial has 20 study locations across Michigan, New York, Oregon, Texas, Buenos Aires. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04877522's enrollment target sits among peer trials
347 4th of 29 higher than 26 of 29 other Chronic Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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