Italian Treatment Free Remission Registry
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- STATUS
- Recruiting
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- End date
- Feb 8, 2030
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- participants needed
- 800
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- sponsor
- University of Turin, Italy
Summary
The investigator propose an extension of the previous National, multicentric study, promoting an observational registry, both retrospective and prospective, in order to expand and further characterize the series of Italian patients with Philadelphia-positive, chronic phase CML (CP-CML) who discontinue TKIs in an off-protocol setting. As safety concerns may arise for patients receiving long-term treatments, and due to the growing number of patients discontinuing TKIs in clinical practice, the study aim to collect all available data regarding feasibility and freedom from progression of the cohort of patients.
Description
This is an observational, retrospective and prospective study of CP-CML patients who discontinue TKIs in Italy. The study will not imply additional costs for the participating centers. Data already present in the clinical charts will be collected.
The patients, answering to inclusion/exclusion criteria will be enrolled in one of the follow cohorts
- Cohort 1 retrospective/prospective study: 293 patients enrolled and reported in Fava et al 2019 with at least 1 year of follow up at the end of the study (February 2017) and 107 patients enrolled but not reported in Fava et al 2019 since their follow-up was shorter than 1 year. The data for these patients will be collected since the end of previous study.
- Cohort 2 retrospective/prospective study: patient not enrolled in the previous study (Fava et al 2019). The data for these patients will be collected since patient diagnosis to the end of the study.
- Cohort 3 prospective study: patients who have discontinued TKI therapy after the study approval in each center. These patients will also participate in the validation process of Phase 2 of a questionnaire developed by an expert panel of eight CML patients with the purpose of capturing the experiences of people along all phases of the TFR.
Patients participating in the study will not be subjected to any procedure that falls outside the clinical practice; in the same way, clinical variables that will be collected for the study are those that are commonly collected by physician in daily clinical practice.
Any decision about drug administration or suspension is made by the physician based on his clinical judgment in the context of clinical practice, independently from decision to include the patient in this study.
Registration of enrolled patients will be done on-line on a key restricted accessible web-database.
Primary objective and endpoint To assess the TFR rate at 1 year from discontinuation of TKIs. Secondary objectives and endpoints
- To further describe the observed population of patients in terms of:
- treatment-free duration; o survival in MR4.5;
- survival in MR3;
- event-free survival;
- progression-free survival;
- deaths after treatment discontinuation;
- rate of achievement of MMR and DMR after treatment re-initiation
- To identify clinical and biological prognostic factors affecting the persistence of off-therapy remission.
- To identify optimal timing and modalities of molecular monitoring of BCR-ABL1 transcript
- Evaluation of the safe minimum monitoring during and after treatment discontinuation
- Evaluation of the maximum MRD positivity level acceptable to safely stay off-treatment
- Evaluation of short-term adverse events (withdrawal syndrome: fever, arthralgia, myalgia, bone pain, weight loss) after treatment discontinuation
- Evaluation of long-term adverse events (i.e. cardiovascular adverse events, second neoplasia) after treatment discontinuation
- Validation of the Italian version of the "Phase 2" of a questionnaire developed by an expert panel of eight CML patients to capture the experiences of people along all phases of the TFR
- Evaluation of patient-reported outcomes describing quality of life of patients off therapy and after resumption of TKIs
Details
| Condition | Chronic myeloid leukemia, Treatment Free Remission, Chronic Myeloid Leukemia, chronic myelogenous leukemia |
|---|---|
| Clinical Study Identifier | NCT04769947 |
| Sponsor | University of Turin, Italy |
| Last Modified on | 26 November 2021 |
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