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NCT01784068 · ClinicalTrials.gov registry record · Phase 2
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
A Phase 2 study of Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 215
- Enrollment target
- 20
- Study locations
NCT01784068: Completed Phase 2 study of Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.
NCT01784068 is a Phase 2 study of Chronic Myelogenous Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 215 participants, below the 275-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01784068, a Phase 2 study of Chronic Myelogenous Leukemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 215 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment
Primary Outcome
The primary endpoint was the percentage of participants in major molecular response (MMR) at 48 weeks after initiation of the treatment-free remission (TFR) phase. Participants who required re-initiation of treatment were considered as non-responders.
Conditions Studied
Interventions
- DRUG Nilotinib followed by treatment-free
Study Locations (20)
Other
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Rankweil
- Novartis Investigative Site - Salzburg
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Charleroi
Florida
- Florida Cancer Specialists - Fort Myers
- Lakes Research - Miami Lakes
- H Lee Moffitt Cancer Center and Research Institute - Tampa
Kansas
- Cancer Center of Kansas - Wichita
Massachusetts
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering - New York
Oregon
- Oregon Health Sciences University - Portland
South Carolina
- Cancer Centers of the Carolinas - Greenville
Tennessee
- Tennessee Oncology PLLC - Chattanooga
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2013-03-19 |
| Est. Completion | 2025-01-23 |
| Phase | Phase 2 |
What the finished NCT01784068 record still lists
NCT01784068 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 275-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Nilotinib followed by treatment-free is the first listed.
NCT01784068 names 20 study sites across 10 states, led by Other, Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT01784068 about?
NCT01784068 is a clinical study titled "Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients". The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment
What is the current status of trial NCT01784068?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 215 participants. The study started on 2013-03-19. Estimated completion is 2025-01-23.
What conditions does trial NCT01784068 study?
This clinical trial studies the following conditions: Chronic Myelogenous Leukemia.
What interventions are being tested in trial NCT01784068?
The interventions under investigation include: Nilotinib followed by treatment-free (DRUG).
Who is sponsoring clinical trial NCT01784068?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01784068 being conducted?
This trial has 20 study locations across Florida, Kansas, Massachusetts, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01784068's enrollment target sits among peer trials
215 8th of 29 higher than 22 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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