Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00124748 · ClinicalTrials.gov registry record · Phase 3
Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 476
- Enrollment target
NCT00124748: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00124748 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 476 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00124748, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 476 participants
- Enrollment target
Study Summary
This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.
Primary Outcome
MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region \[Bcr\] gene and Abelson proto-oncogene \[Abl\] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction \[RT-PCR\] (performed centrally).
Interventions
- DRUG Imatinib mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 476 participants |
| Start Date | 2005-06 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
Why NCT00124748 stopped before completion
NCT00124748 is an interventional study that assigns participants to a tested intervention. The registered 476 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Imatinib mesylate is the first listed.
NCT00124748 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00124748 about?
NCT00124748 is a clinical study titled "Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)". This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.
What is the current status of trial NCT00124748?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 476 participants. The study started on 2005-06. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00124748?
The interventions under investigation include: Imatinib mesylate (DRUG).
Who is sponsoring clinical trial NCT00124748?
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 NCT00124748's enrollment target sits among peer trials
476 808th of 2000 higher than 1,193 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
- NCT06754046 · 476 participants · NA
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
- NCT03911700 · 477 participants · NA
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
- NCT06997497 · 477 participants · Phase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
- NCT01788839 · 475 participants
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia