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NCT01735955 · ClinicalTrials.gov registry record · Phase 4
Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
A Phase 4 study of Acute Lymphoblastic Leukemia (ALL) and Chronic Myelogenous Leukemia (CML), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 57
- Enrollment target
- 20
- Study locations
NCT01735955: Completed Phase 4 study of Acute Lymphoblastic Leukemia (ALL) and Chronic Myelogenous Leukemia (CML), sponsored by Novartis Pharmaceuticals.
NCT01735955 is a Phase 4 study of Acute Lymphoblastic Leukemia (ALL) and Chronic Myelogenous Leukemia (CML) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 57 participants, below the 6,302-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01735955, a Phase 4 study of Acute Lymphoblastic Leukemia (ALL) and Chronic Myelogenous Leukemia (CML), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 57 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the treatment as judged by the investigator
Primary Outcome
An Adverse Event (AE) is any untoward medical occurrence (eg any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Serious adverse event (SAE) case data were collected in the Safety Database. Adverse event (AE) data
Conditions Studied
Interventions
- DRUG Nilotinib
Study Locations (20)
Other
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Hong Kong SAR
- Novartis Investigative Site - Budapest
- Novartis Investigative Site - Budapest
- Novartis Investigative Site - Haifa
- Novartis Investigative Site - Amsterdam
- Novartis Investigative Site - Leiden
Ontario
- Novartis Investigative Site - Hamilton
- Novartis Investigative Site - Toronto
New York
- Novartis Investigative Site - Albany
Texas
- Novartis Investigative Site - Houston
British Columbia
- Novartis Investigative Site - Vancouver
Nova Scotia
- Novartis Investigative Site - Halifax
BO
- Novartis Investigative Site - Bologna
GE
- Novartis Investigative Site - Genova
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-03-29 |
| Est. Completion | 2023-07-07 |
| Phase | Phase 4 |
What the finished NCT01735955 record still lists
NCT01735955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 6,302-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Acute Lymphoblastic Leukemia (ALL) appearing as the primary indexed condition, and to 1 intervention - of which Nilotinib is the first listed.
NCT01735955 names 20 study sites across 11 states, led by Other, Ontario, New York.
Frequently Asked Questions
What is clinical trial NCT01735955 about?
NCT01735955 is a clinical study titled "Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study". The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the treatment as judged by the investigator
What is the current status of trial NCT01735955?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2013-03-29. Estimated completion is 2023-07-07.
What conditions does trial NCT01735955 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Receptor Tyrosine Kinase (KIT) Mutated Melanoma.
What interventions are being tested in trial NCT01735955?
The interventions under investigation include: Nilotinib (DRUG).
Who is sponsoring clinical trial NCT01735955?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01735955 being conducted?
This trial has 20 study locations across New York, Texas, British Columbia, Nova Scotia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia (ALL)
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 NCT01735955's enrollment target sits among peer trials
57 8th of 16 higher than 9 of 16 other Acute Lymphoblastic Leukemia (ALL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia (ALL) 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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