Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01593254 · ClinicalTrials.gov registry record · Phase 2
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 262
- Enrollment target
NCT01593254: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01593254 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 262 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01593254, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 262 participants
- Enrollment target
Study Summary
The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.
Primary Outcome
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals. P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (\<=4 weeks vs \>
Interventions
- DRUG Dasatinib
- DRUG Imatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2012-09-12 |
| Est. Completion | 2022-04-12 |
| Phase | Phase 2 |
What the finished NCT01593254 record still lists
NCT01593254 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 2 interventions - of which Dasatinib is the first listed.
NCT01593254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01593254 about?
NCT01593254 is a clinical study titled "Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib". The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.
What is the current status of trial NCT01593254?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 262 participants. The study started on 2012-09-12. Estimated completion is 2022-04-12.
What interventions are being tested in trial NCT01593254?
The interventions under investigation include: Dasatinib (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT01593254?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01593254's enrollment target sits among peer trials
262 210th of 2000 higher than 1,791 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
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
- NCT03713268 · 262 participants
Intraoperative OCT Guidance of Intraocular Surgery II
- NCT06074380 · 262 participants · Phase 4
Non Inferiority Trial Investigating Surfactants Administered Via MIST
- NCT06293703 · 262 participants · NA
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
- NCT06780137 · 262 participants · Phase 1
A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
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