A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)

• Status: Active, not recruiting
• Trial end date: 2025-01-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Center for Hematology, Russia
• Treatments: Dasatinib; Imatinib Mesylate

Criteria

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