Clinical trial · Observational
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.
- 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)
Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib. Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRQOL Survey Packet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study population
- interventionNames
- Other: HRQOL Survey Packet
Primary outcomes (1)
- measure
- Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
- timeFrame
- By the end of the study.
Secondary outcomes (5)
- measure
- Psychological wellbeing.
- timeFrame
- By the end of the study.
- measure
- Fatigue.
- timeFrame
- By the end of the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years. * CML patients meeting the following criteria: * Started IM therapy in the early chronic phase (ECP). * Have been undergoing treatment with IM, as first line therapy, for at least three years regardless of the current prescribed dose of IM. * In complete cytogenetic response (CCgR) and no clinical evidence of disease progression to accelerated phase (AP) or blast crisis (BC). * Able to read and write Italian. * Freedom from psychiatric conditions that may confound HRQOL evaluation. * Informed consent provided. Exclusion Criteria: * CML patients who were initially diagnosed in the AP or BC or those who started therapy with IM in the late chronic phase (LCP). * Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide). * Patients with a new primary malignancy.
References
Publications (1)
- BACKGROUNDEfficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, Deliliers GL, Barate C, Rossi AR, Fioritoni G, Luciano L, Turri D, Martino B, Di Raimondo F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Ulisciani S, Veneri D, Sica S, Rambaldi A, Vignetti M, Mandelli F; GIMEMA. Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood. 2011 Oct 27;118(17):4554-60. doi: 10.1182/blood-2011-04-347575. Epub 2011 Jul 12. PMID 21750313