Ongoing Clinical Trials for Chronic Myeloid Leukaemia (in Remission)
Two clinical trials are currently recruiting patients with chronic myeloid leukaemia in remission to explore whether treatment with tyrosine kinase inhibitors can be safely stopped after achieving deep molecular remission. These studies are being conducted in Germany and Czechia, focusing on maintaining disease control without continuous medication.
Clinical trial locations
- Czechia
- Germany
Study on Stopping Nilotinib for Chronic Myeloid Leukemia Patients After Previous Unsuccessful Attempts to Stop Tyrosine Kinase Inhibitors
This trial is taking place in Germany and focuses on patients who have previously tried to stop their treatment with tyrosine kinase inhibitors without success. The study examines whether patients can maintain remission after stopping nilotinib (marketed as Tasigna) for a second or third time.
Who can participate: The trial is open to adults aged 18 and older who have a confirmed diagnosis with specific genetic markers (Ph chromosome and/or BCR-ABL fusion gene). Participants must have previously attempted to stop treatment with imatinib or similar medications without success, and must have been treated with any tyrosine kinase inhibitor for at least one year after their first or second stop attempt. Written informed consent is required.
Who cannot participate: Patients are excluded if they have not been treated with a tyrosine kinase inhibitor for at least one year after their first stop attempt, have not maintained a stable molecular response (MR4 for at least one year or MR4.5 for at least six months) before stopping treatment, have not been treated with nilotinib for at least two years, have not had at least three years of prior treatment, or did not meet the criteria for a failed first or second stop attempt.
Study focus: The main goal is to evaluate how long patients can remain in remission after stopping nilotinib for a second or third time. Participants will stop taking the medication and undergo regular monitoring to assess their remission status at 12 months and 36 months. The study will also track overall survival and the likelihood of disease progression. Regular check-ups will continue until 2028 to evaluate long-term outcomes.
Investigational drug: Nilotinib is a tyrosine kinase inhibitor that works by blocking specific proteins that promote the growth of cancer cells. In this trial, patients have already been treated with nilotinib for at least two years and achieved stable remission. The medication is taken orally in capsule form.
Study on Stopping Nilotinib, Imatinib, and Dasatinib in Patients with Chronic Myeloid Leukemia in Deep Remission
This trial is being conducted in Czechia and investigates whether patients in deep molecular remission can safely stop treatment after gradually reducing their medication doses. The study involves three different tyrosine kinase inhibitors: nilotinib (Tasigna), imatinib (Glivec), and dasatinib (SPRYCEL).
Who can participate: Adults aged 18 to 65 years with confirmed chronic phase disease are eligible. Patients must have a measurable BCR-ABL1 genetic marker and have been on tyrosine kinase inhibitor treatment for more than 4 years. They must have maintained deep molecular response for at least 2 years. Previous treatment with interferon-alpha is allowed. Participants of childbearing potential must agree to use reliable birth control methods during the study and for one year after the last dose.
Who cannot participate: The trial excludes patients who are not in deep remission, those who have not been taking a tyrosine kinase inhibitor, and individuals outside the 18-65 age range. Vulnerable populations requiring special protection or care are also excluded.
Study focus: The trial examines whether patients can maintain remission after a gradual two-step dose reduction followed by complete medication discontinuation. Regular monitoring will assess BCR-ABL1 levels to ensure patients maintain major molecular response (keeping levels at or below 0.1%). Follow-up assessments are scheduled at 6, 12, 18, 24, and 36 months. If the disease shows signs of returning, medication may be restarted. The study will also evaluate side effects during dose reduction and discontinuation, as well as impacts on other health factors such as cholesterol and blood sugar levels.
Investigational drugs: The trial involves three tyrosine kinase inhibitors taken orally. These medications work by blocking specific enzymes that promote cancer cell growth. The goal is to determine if patients can maintain disease control after stopping these medications, which could improve quality of life by reducing medication-related side effects.
Summary
Both clinical trials focus on an important question for patients in remission: whether treatment can be safely stopped after achieving deep molecular response. The German trial specifically addresses patients who have previously attempted to stop treatment without success, offering them another opportunity to discontinue medication with careful monitoring. The Czech trial takes a more gradual approach, testing whether dose reduction before complete discontinuation can help maintain remission.
These studies reflect a growing interest in treatment-free remission for patients who have achieved excellent disease control. Both trials emphasize rigorous monitoring to detect any signs of disease return early, with plans to restart medication if needed. The trials are expected to provide valuable insights into managing chronic myeloid leukaemia more effectively while potentially reducing the burden of continuous medication for patients in stable remission.
