Clinical trial · Interventional
A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)
Prospective Non-randomized Stratified Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib) in Adults With Ph+ Chronic Myeloid Leukemia With Stable Deep Molecular Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCR-ABL Positive Chronic Myelogenous Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Myeloid Leukemia in Remission | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The TKI dose reduction
- description
- Imatinib, nilotinib, dasatinib or bosutinib; the two stage of TKI dose reduction phase for 12 months (6 months and 6 months, respectively).
- interventionNames
- Drug: Imatinib
- Drug: Nilotinib
- Drug: Dasatinib
- Drug: Bosutinib
Primary outcomes (1)
- measure
- Overall survival, survival without molecular relapse
- timeFrame
- 37 months
Secondary outcomes (9)
- measure
- The proportion of patients with molecular relapse who achieved MMR and DMR after the resumption TKI therapy in standard doses
- timeFrame
- 37 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. CML in chronic phase. 2. TKI treatment for at least 3 years. 3. DMR (BCR-ABL≤0.01%) for at least 1 year, MMR (BCR-ABL≤0.1%) for at least 2 years 4. At least 3 molecular results over the preceding 24 months, which confirm the presence of MMR and DMR 5. Written Informed Consent 6. CML patients with DMR for at least 1 years and MMR for at least 2 years after STOP TKI in anamnesis. For patients who are on the reduced dose TKI (1 stage) at the time of inclusion in the study 1\. The duration of therapy at reduced doses of TKI phase I is at least 6 months. For patients on the reduced dose TKI (2 stage, before TFR phase) at the time of inclusion in the study 1. DMR (BCR-ABL≤0.01%) for at least 2 years 2. The duration of therapy at reduced doses of TKI phase 1 is for at least 6 months, the total duration of therapy at reduced doses is for at least 12 months. Exclusion Criteria: 1. Age under 18 2. ECOG \>2 3. CML in accelerated phase or blast crisis at any time 4. Lack of Written Informed Consent 5. Pregnant or lactating women 6. Incapacity
References
Publications (0)
Data not yet available