Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00471497 · ClinicalTrials.gov registry record · Phase 3
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 846
- Enrollment target
NCT00471497: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00471497 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 846 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00471497, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 846 participants
- Enrollment target
Study Summary
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.
Primary Outcome
MMR is defined as the percentage of participants in MMR (reduction of ≥ 3 logs in BCR-ABL transcripts compared to the standardized baseline established in IRIS, or ≤ 0.1% BCR-ABL/ABL % by international scale and measured by real-time quantitative polymerase chain reaction (RQ-PCR)) at 12 months.
Interventions
- DRUG imatinib
- DRUG nilotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 846 participants |
| Start Date | 2007-07-31 |
| Est. Completion | 2019-08-21 |
| Phase | Phase 3 |
What the finished NCT00471497 record still lists
NCT00471497 is an interventional study that assigns participants to a tested intervention. The registered 846 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which imatinib is the first listed.
NCT00471497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00471497 about?
NCT00471497 is a clinical study titled "A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)". In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension pr...
What is the current status of trial NCT00471497?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 846 participants. The study started on 2007-07-31. Estimated completion is 2019-08-21.
What interventions are being tested in trial NCT00471497?
The interventions under investigation include: imatinib (DRUG), nilotinib (DRUG).
Who is sponsoring clinical trial NCT00471497?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00471497's enrollment target sits among peer trials
846 391st of 2000 higher than 1,610 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02757859 · 845 participants · NA
High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery
- NCT07142408 · 848 participants · Phase 3
The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal
- NCT06747949 · 844 participants · Phase 3
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
- NCT06439979 · 843 participants · NA
Rural Adult and Youth Sun Protection Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI