NO_LONGER_AVAILABLENot Applicable

Nilotinib, for Patients With CML-CP or CML-AP

Plain-language summary

The purpose of this Cohort Treatment Plan is to allow access to Nilotinib for eligible patients diagnosed with imatinib-intolerant and/or resistant Philadelphia Chromosome positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) or Chronic Myelogenous Leukemia in Accelerated Phase (CML-AP). The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. One of the diagnoses listed below

Exclusion criteria

✕. History of hypersensitivity to any drugs or metabolites of similar chemical classes as nilotinib.
✕. Previous treatment with any cytotoxic investigational drug ≤4 weeks prior to beginning nilotinib. At least 2 weeks must have elapsed since the last dose of hormonal therapy or any approved or investigational "targeted" kinase inhibitor agent with the exception of imatinib which must be discontinued at least 5 days prior to beginning therapy with nilotinib.
✕. Impaired cardiac function, including any one of the following:
✕. any medications that prolong the QT interval and CYP3A4 inhibitors if the treatment cannot Use of be either safely discontinued or switched to a different medication prior to starting treatment. Please see http://crediblemeds.org/index.php for a comprehensive list of agents that prolong the QT interval
✕. Severe and/ or uncontrolled concurrent medical disease that in the opinion of the treating physicians could cause unacceptable safety risks or compromise compliance with the compassionate use treatment (e.g. impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection, uncontrolled diabetes, )
✕. Patients who have undergone major surgery ≤ 2 weeks prior to Visit 1 or who have not recovered from side effects of such surgery
✕. Known Cytopathologically confirmed Central Nervous System infiltration.
✕. Use of therapeutic warfarin.

Trial details

NCT IDNCT04518644

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Chronic Myelogenous Leukemia (CML) trials