Phase 2
Completed N=59
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
CML
Source: ClinicalTrials.gov NCT01744665 ↗
Enrolled (actual)
59
Serious AEs
32.2%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase — 12 Participants
Summary
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase |
12 | — |
| SECONDARY Relapse Free Survival is Defined as Time From the Date of Nilotinib Treatment Discontinuation to the First Documented Molecular Relapse (Confirmed Loss of MR4.5). |
21.4 | — |
| SECONDARY Percentage of Participants Without Molecular Relapse Within 12 and 24 Months After Starting the Treatment -Free Remission (TFR) Phase |
8; 2 | — |
| SECONDARY Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse |
7; 17; 17 | — |
| SECONDARY Number of Participants Who Progressed to Accelerated Phase/Blastic Crisis (AP/BC) or Died From From Any Cause. |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment |
0.125; 0.012; 0.021; 0.026; 0.160; -0.005 | — |
| SECONDARY Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set |
83.250; 2.000; 3.250; 1.350; 80.00; 10.00 | — |
| SECONDARY Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set |
50.508; 50.720; 49.020; 47.648; 48.382; 46.605 | — |
| SECONDARY Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set |
22; 4; 0; 25; 1; 0 | — |
| SECONDARY Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set |
23; 8; 0; 31; 0; 0 | — |
| SECONDARY Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set |
19; 8; 0; 28; 0; 0 | — |
| SECONDARY Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set |
7; 3; 0; 10; 0; 0 | — |
| SECONDARY Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set |
4; 1; 0; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of CML
- Treated with at least 1 year of imatinib
- Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale confirmed during screening
- Written informed consent obtained prior to any screening procedures performed
Exclusion Criteria
- T315I mutation
- Prior imatinib failure or had accelerated phase or blast crisis CML
- Impaired cardiac function
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01744665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.