Phase 4
Completed N=171
Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.
Source: ClinicalTrials.gov NCT02546674 ↗Enrolled (actual)
171
Serious AEs
22.2%
Results posted
Jul 2022
Primary outcomePrimary: Percentage of Participants With Deep Molecular Response MR4.5 at 24 Months of Study Treatment — 35.3 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Deep Molecular Response MR4.5 at 24 Months of Study Treatment |
35.3 | — |
| SECONDARY Percentage of Participants With MR4 at 24 Months of Study Treatment. |
44.9 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (MMR) at 12 Months of Study Treatment |
60.3 | — |
| SECONDARY Percentage of Participants With Complete Cytogenetic Response (CCyR) at 6 Months of Study Treatment |
89.5 | — |
| SECONDARY Progression-free Survival |
NA | — |
| SECONDARY Time to Progression to AP/BC |
NA | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL) |
5.1; 6.3; 6.0; 4.0; 2.4 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Physical Functioning |
0.2; 0.7; -1.4; -0.7; -3.2 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Role Functioning |
-0.1; 2.0; 0.5; 0.4; 0.4 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Emotional Functioning |
8.1; 8.6; 7.2; 4.7; 0.0 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Cognitive Functioning |
-2.3; -3.8; -7.1; -8.0; -8.3 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Social Functioning |
-0.7; 0.3; -1.2; -1.2; -9.2 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia Specific 24 (EORTC QLQ-CML 24): Symptom Burden |
2.9; 2.4; 3.6; 2.5; 3.2 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia Specific 24 (EORTC QLQ-CML 24): Impact on Worry/Mood |
-3.4; -4.7; -6.0; -3.8; -2.0 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia Specific 24 (EORTC QLQ-CML 24): Impact on Daily Life |
-3.6; -6.4; -6.2; -6.4; -10.0 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia Specific 24 (EORTC QLQ-CML 24): Satisfaction With Care and Information |
4.3; 5.6; -0.6; 2.2; 12.3 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia Specific 24 (EORTC QLQ-CML 24): Body Image Problems |
2.1; 3.1; 7.0; 5.7; 3.3 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia Specific 24 (EORTC QLQ-CML 24): Satisfaction With Social Life |
3.9; 9.7; 6.6; 8.5; 14.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML in chronic phase
- Patients must be previously untreated for CML with the exception of 6 months treatment with hydroxyurea and a maximum of 6 weeks treatment with imatinib
- Adequate end organ function
- Normal serum levels ≥ lower limit of normal (LLN) of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication.
Key Exclusion Criteria
- Known impaired cardiac function like long QT syndrome, history of myocardial infarction or unstable angina in the past 12 months.
- Patients who are pregnant or breast feeding.
Other inclusion/exclusion criteria might apply
Data sourced from ClinicalTrials.gov (NCT02546674). 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.