Clinical trial · Observational
Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
Retro-prospective Observational Study on Risk of Progression in Chronic Phase-Chronic Myeloid Leukemia Patients Eligible for Tyrosine Kinase Inhibitor Discontinuation (TFR - PRO)
NCT04621851CI-TRIAL-00092768completedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to investigate the safety profile of TKI discontinuation in clinical practice, with particular regard on the risk of progression after treatment discontinuation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Retrospective cohort
- description
- Patients who discontinued before the opening of this study will contribute to the retrospective cohort.
- label
- Prospective cohort
- description
- Patients who will discontinue after it will contribute to the prospective cohort.
- label
- Retrospective/Prospective cohort
- description
- Patients who discontinued before the opening of this study but will continue their discontinuation after it, will contribute to both cohorts.
Primary outcomes (1)
- measure
- The quantification of the risk of progression
- timeFrame
- 36 Month
- description
- To quantify the risk of progression to accelerated phase (AP) or blast phase (BP), expressed as time adjusted rate (TAR), after TKI discontinuation in CML patients who undergo a first or subsequent TKI discontinuation attempt
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed and dated IRB/IEC-approved informed consent for the prospective cohort patients. 2. Age \>= 18 years. 3. Male or female patients with CML diagnosed in chronic phase (CP). 4. At least 4 years of TKI treatment. 5. At least 18 months of DMR. Exclusion Criteria: * Allogeneic hematopoietic stem cell transplantation. * CML diagnosed in AP or BC
References
Publications (0)
Data not yet available
No reference posted for this study.