Phase 4
N=45
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response
Philadelphia Chromosome Positive · Chronic Myelogenous Leukemia in Chronic Phase
Bottom Line
View on ClinicalTrials.gov: NCT01043874 ↗Enrolled (actual)
45
Serious AEs
15.6%
Results posted
Feb 2015
Primary outcome: Primary: MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later. — 51.1 % participants achieving MMR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nilotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later. |
51.1 | — |
| SECONDARY MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) |
66.7 | — |
| SECONDARY Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) . |
5.19 | — |
| SECONDARY Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) . |
51.1 | — |
Summary
To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.
Eligibility Criteria
Inclusion Criteria
- Male or female patients ≥ 18 years of age.
- ECOG 0, 1, or 2.
- Have been diagnosed with Ph+ CML-CP and receiving imatinib therapy.
- Patients with suboptimal molecular response to imatinib treatment continued for at least 18 months (first line therapy)
Suboptimal molecular response defined as all of the following conditions:
- Patients who have achieved CCyR (0% Ph+ chromosomes).
- Patients who don't achieve MMR (MMR defined as BCR-ABL/ABL ratio of ≤ 0.1% on the International Scale as detected by RQ-PCR).
The treatment with imatinib defined as:
Dose of 300 mg or higher daily must be maintained for a minimum of 3 months prior to study entry.
- Patients who meet the following laboratory tests criteria:
- total bilirubin 450 msec on screening ECG
- Use of a ventricular-paced pacemaker
- Myocardial infarction during the last 12 months
- Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina).
- Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St John's Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See Section 6.4.3 for complete list of these medications.
Data sourced from ClinicalTrials.gov (NCT01043874). 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.