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NCT01844765 · ClinicalTrials.gov registry record · Phase 2
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
A Phase 2 study of Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT01844765: Completed Phase 2 study of Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.
NCT01844765 is a Phase 2 study of Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01844765, a Phase 2 study of Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
Primary Outcome
MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR at 6 cycles if the patient met the MMR criteria at the Cycle 6 Visit.
Conditions Studied
Interventions
- DRUG nilotinib
Study Locations (20)
Other
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Poitiers
- Novartis Investigative Site - Budapest
California
- Loma Linda University Cancer Center - Loma Linda
- Lucile Salter Packard Children's Hospital at Stanford - Palo Alto
Florida
- Nemours Childrens Hospital - Orlando
- St. Mary's Hospital - West Palm Beach
Texas
- University of Texas Southwestern Medical Center Oncology - Dallas
- Cook Children's Medical Center Oncology - Fort Worth
Maryland
- Johns Hopkins Oncology Center ORA - Baltimore
North Carolina
- UNC Chapel Hill - Chapel Hill
Ohio
- Nationwide Childrens Hospital - Columbus
Washington
- Seattle Childrens Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2013-08-20 |
| Est. Completion | 2020-08-28 |
| Phase | Phase 2 |
What the finished NCT01844765 record still lists
NCT01844765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention - of which nilotinib is the first listed.
NCT01844765 names 20 study sites across 14 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01844765 about?
NCT01844765 is a clinical study titled "Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.". To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
What is the current status of trial NCT01844765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2013-08-20. Estimated completion is 2020-08-28.
What conditions does trial NCT01844765 study?
This clinical trial studies the following conditions: Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia.
What interventions are being tested in trial NCT01844765?
The interventions under investigation include: nilotinib (DRUG).
Who is sponsoring clinical trial NCT01844765?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01844765 being conducted?
This trial has 20 study locations across California, Florida, Maryland, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01844765's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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