Phase 4
Completed N=52
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
Source: ClinicalTrials.gov NCT00980018 ↗Enrolled (actual)
52
Serious AEs
17.3%
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3 — 37; 43; 44 Participants
◆ Published Evidence
Established
35citations · ~4 / year
Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study.
Summary
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
Linked Publications
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Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3 |
37; 43; 44 | — |
| SECONDARY Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline |
2; 3; 0; 2; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline |
2; 6; 3; 2; 2; 0 | — |
| SECONDARY Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy |
-0.177; -0.407; -0.540; -0.718; -0.844; -0.902 | — |
| SECONDARY Duration of Complete Cytogenetic Response |
319.7; 266.3 | — |
| SECONDARY Time to Complete Cytogenetic Response in Participants Not Reporting at Baseline |
1.9 | — |
| SECONDARY Duration of Major Molecular Response |
277.6; 208.3 | — |
| SECONDARY Time to Major Molecular Response (MMR) in Participants With MMR Absent at Baseline |
2.8 | — |
| SECONDARY Time to Optimal Imatinib-related Adverse Event Improvement |
1.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
- Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
- Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
- CML-CP patients initiated on any dose of imatinib
- Ability to provide written informed consent prior to any study related screening procedures being done
Exclusion Criteria
- Loss of CHR or cytogenetic response
- Prior accelerated phase or blast phase CML
- Previously documented T315I mutation
- Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
- Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
- Treatment with other investigational agents within 30 days of Day 1.
- History of non-compliance to medical regimens or inability to grant consent.
- Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00980018) 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.