Phase 3
Completed N=620
A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
Source: ClinicalTrials.gov NCT01743989 ↗Enrolled (actual)
620
Serious AEs
22.0%
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase — 31.9; 37.5 Percentage of participants — p=0.383
◆ Published Evidence
Emerging
1citation · ~0 / year
Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy.
Summary
This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.
Linked Publications
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Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase |
31.9; 37.5 | 0.383 |
| SECONDARY Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry |
69.6; 37.5; 29.6; 100; 100.0; 64.3 | — |
| SECONDARY Cumulative Incidence of MMR During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry |
48.9; 38.3; 12.9; 85.9; 81.9; 26.6 | — |
| SECONDARY Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry |
97.9; 97.9; 97.9; 97.9 | — |
| SECONDARY Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry |
21.1; 17.4; 4.0; 38.5; 38.5; 8.6 | — |
| SECONDARY Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry |
70.6; 76.1; 84.4; 87.2 | — |
| SECONDARY Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase |
80.8; 86.4; 74.3; 94.2; 91.5; 81.9 | — |
| SECONDARY Cumulative Incidence of MMR During the Post-randomization Consolidation Phase |
98.3; 98.3; 98.3; 98.3 | — |
| SECONDARY Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase |
23.3; 20.3; 6.3; 60.8; 50.8; 18.4 | — |
| SECONDARY Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase |
98.3; 98.3; 98.3; 98.3 | — |
| SECONDARY Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase |
9.2; 7.6; 1.8; 28.3; 23.7; 5.8 | — |
| SECONDARY Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase |
72.9; 78.0; 85.6; 88.1 | — |
| SECONDARY Percentage of Participants Who Were in MMR During TFR Phase |
97.5; 94.2; 84.9; 80.8; 62.2; 61.5 | — |
| SECONDARY Percentage of Participants Who Were in MR4.0 During the TFR Phase |
87.4; 83.7; 58.0; 56.7; 39.5; 42.3 | — |
| SECONDARY Percentage of Participants Who Were in MR4.5 During the TFR Phase |
21.8; 26.9; 17.6; 28.8; 20.2; 26.9 | — |
| SECONDARY BCR-ABL Ratio (Expressed as a Percentage) During the Induction/Consolidation Phase |
0.1367; 0.0633; 0.5509; 0.0106; 0.0086; 0.0728 | — |
| SECONDARY BCR-ABL Ratio (Expressed as a Percentage) During the TFR Phase |
0.0042; 0.0074; 0.1162; 0.2122; 1.3774; 0.4754 | — |
| SECONDARY BCR-ABL Ratio (Expressed as a Percentage) During the Nilotinib Re-treatment Phase |
2.8246; 0.6301; 0.6276; 0.3112; 0.0311; 0.0131 | — |
| SECONDARY Progression-free Survival (PFS) During the TFR Phase of the Study. |
NA; NA | — |
| SECONDARY Treatment -Free Survival (TFS) During the TFR Phase of the Study |
4.1; 4.2 | — |
| SECONDARY Overall Survival (OS) Rate During the TFR Phase of the Study. |
NA; NA | — |
Eligibility Criteria
Key Inclusion Criteria
- Confirmed diagnosis of chronic phase Ph+ CML
- Previous first-line treatment with imatinib for a minimum of 2 years;
- Patient in complete cytogenetic response;
Key Exclusion Criteria
- Previous achievement of MR4.0 at study entry;
- Previous treatment with other target cells inhibitors other than imatinib;
- Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
- Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
- Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
- History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
- Patients who have not recovered from prior surgery;
- Treatment with other investigational agents within 4 weeks of Day 1;
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
Other inclusion/exclusion criteria might apply.
Data sourced from ClinicalTrials.gov (NCT01743989) and the linked publication. 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.