A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia (NCT03874858) | Clinical Trial Compass
CompletedPhase 2
A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia
Italy124 participantsStarted 2019-03-22
Plain-language summary
This study is constituted of two stage: Treatment-Free Remission 1 (TFR1) stage and Treatment-Free Remission 2 (TFR2) stage.
The purpose of the TFR1 stage is to assess the effect of nilotinib reduced to half the standard dose for 12 months on treatment-free remission in patients with Chronic Myeloid Leukemia - Chronic Phase (CML-CP) treated with first-line nilotinib who reached a sustained deep molecular response before entering the study.
The purpose of the TFR2 stage is to evaluate whether the use of asciminib in combination with nilotinib after failure of a first attempt at TFR can lead to higher and more durable TFR rates after a second attempt at TKI discontinuation than those reported in other studies.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Male and female patients 18 years or older.
✓. Diagnosis of CML-CP according to the World Health Organization (WHO).
✓. Patients with CML-CP under first-line treatment with nilotinib at the approved daily dose of 300 mg BID mg for at least 3 calendar years.
✓. Sustained DMR defined as ≥ MR 4.0 (BCR-ABL level ≤0.01% IS) in all of the last 4 BCR-ABL RQ-PCR assessments with a minimum interval between each assessment of 3 months and a maximum interval of 6 months.
✓. Patient must meet the following laboratory values at the screening visit:
✓. Eastern Cooperative Oncology Group performance status (ECOG) 0-2.
✓. Study subjects must be able to comply with study procedures and follow-up examinations.
✓. Signed informed consent to the TFR1 stage from the patient or from his/her legal representative.
Exclusion criteria
✕. Patients with known atypical transcript.
What they're measuring
1
Percentage of patients in full treatment-free remission 96 weeks after the start of the consolidation period of TFR1 stage
Timeframe: Baseline of consolidation phase up to 96 weeks of TFR1 stage
2
Percentage of patients in treatment-free remission 48 weeks after starting a second attempt at treatment-free remission during TFR2 stage.
Timeframe: Baseline TFR2 phase (week 96 of TFR2 stage) up to week 144 of TFR2 stage
✕. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if 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).
✕. Dose reductions/interruptions due to neutropenia or thrombocytopenia in the past 6 months.
✕. Patient ever attempted to permanently discontinue 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.
✕. History of acute pancreatitis within 1 year prior to study entry or past medical history of chronic pancreatitis.
✕. Known presence of a significant congenital or acquired bleeding disorder unrelated to cancer.