Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) (NCT01698905) | Clinical Trial Compass
CompletedPhase 2
Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)
United States163 participantsStarted 2012-12-20
Plain-language summary
A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Male or female patients \>= 18 years of age
✓. ECOG Performance Status of 0, 1, or 2
✓. Patient with diagnosis of BCR-ABL positive CML CP
✓. Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment (first with imatinib (\> 4 weeks) and then switched to nilotinib) since initial diagnosis
✓. Patient has at least 2 years of nilotinib treatment prior to study entry.
✓. Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
✓. Adequate end organ function as defined by:
✓. Patients must have the following electrolyte values ≥ LLN (lower limit of normal) limits or corrected to within normal limits with supplements prior to the first dose of study medication:
Exclusion criteria
✕. Prior AP, BC or allo-transplant
✕. Patient has documented MR4.5 at the time when switched from imatinib to nilotinib
✕. Patients with known atypical transcript
✕. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past)
What they're measuring
1
Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks
Timeframe: First 48 weeks following nilotinib cessation.
✕. Dose reductions due to neutropenia or thrombocytopenia in the past 6 months
✕. Patient ever attempted to permanently discontinue imatinib or nilotinib treatment
✕. Known impaired cardiac function including any one of the following:
✕. 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 (e.g. uncontrolled diabetes (defined as HbA1c \> 9%), uncontrolled infection)