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
Source : Import from center
Cohorts
Proposed Therapy or Intervention
Cohorts
Name
Medical condition
Treatment
Recruitment status
Retrospective cohort
Patients who discontinued before the opening of this study will contribute to the retrospective cohort.
Data not available
Unknown
Prospective cohort
Patients who will discontinue after it will contribute to the prospective cohort.
Data not available
Unknown
Retrospective/Prospective cohort
Patients who discontinued before the opening of this study but will continue their discontinuation after it, will contribute to both cohorts.
Data not available
Unknown
Retrospective cohort
Recruitment status
unknown
Patients who discontinued before the opening of this study will contribute to the retrospective cohort.
Prospective cohort
Recruitment status
unknown
Patients who will discontinue after it will contribute to the prospective cohort.
Retrospective/Prospective cohort
Recruitment status
unknown
Patients who discontinued before the opening of this study but will continue their discontinuation after it, will contribute to both cohorts.
Current data since :
July 28, 2025 20:00
Study's description
Study description
Study summary
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.
Source : Import from center
This study will enroll approximately 3000 CP-CML patients that must have a history of at least 4 years of TKI treatment and at least 18 months of DMR. Events developing in patients after the end of discontinuation and TKI resumption will be considered as linked to the discontinuation if they will develop within 36 months from the end of discontinuation. This rule will apply also to subsequent TD attempts. In case of a second or subsequent discontinuation attempt after the failure of a previous one (for molecular relapse), patients must have re-achieved a DMR with TKI therapy resumption and must keep DMR for at least 18 months before another TD.
Collection of data will be retrospective and prospective, as each center will collect the data for 24 months. Patients who discontinued before the opening of this study will contribute to the retrospective cohort, while those who will discontinue after it will contribute to the prospective cohort. Patients who discontinued before the opening of this study but will continue their discontinuation after it, will contribute to both cohorts. For patients prospectively recruited, monitoring of disease status will be performed to assess the maintenance of the molecular remission during the study period.
Patients with an atypical BCR-ABL1 fusion gene, which does not allow the use of Q-RT-PCR, will be monitored by qualitative PCR and will be analyzed separately. For these patients, negativity of nested qualitative RT-PCR will be considered a surrogate of DMR of patients monitored by Q-RT-PCR, while loss of negativity of first-round qualitative PCR will be considered a surrogate of loss of MMR (i.e. molecular relapse). Accordingly, for patients monitored by qualitative PCR, TKI resumption after TD will be provided in case of a new positivity of first-round PCR.
.
Source : Import from center
Locations
Locations
Participating centers
10
shown
out of
26
centers
CENTRE UNIVERSITAIRE DE SANTÉ MCGILL
Montréal
QUÉBEC, CANADA
Local recruitment
Recruiting status:
CLOSED
ASST-MONZA
Monza
ITALY/MB, ITALY
Local recruitment
Recruiting status:
CLOSED
AZIENDA OSPEDALIERA DI RILIEVO NAZIONALE "A. CARDARELLI"
Napoli
ITALY
Local recruitment
Recruiting status:
CLOSED
AZIENDA OSPEDALIERA UNIVERSITARIA UNIVERSITÀ DEGLI STUDI DI NAPOLI "FEDERICO II" FACOLTÀ DI MEDICINA E CHIRURGIA
Napoli
ITALY
Local recruitment
Recruiting status:
CLOSED
AZIENDA UNITÀ SANITARIA LOCALE IRCCS
Reggio emilia
ITALY
Local recruitment
Recruiting status:
CLOSED
CHARITÉ UNIVERSITY OF BERLIN - CLINIC OF MEDICINE - HEMATOLOGY AND ONCOLOGY
Berlin
GERMANY
Local recruitment
Recruiting status:
CLOSED
CTMO EMATOLOGIA OSPEDALE "BUSINCO"
Cagliari
ITALY
Local recruitment
Recruiting status:
CLOSED
DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA S.C. EMATOLOGIA 2 A.O. CITTÀ DELLA SALUTE E DELLA SCIENZA DI TORINO S. G.BATTISTA
Torino
ITALY
Local recruitment
Recruiting status:
CLOSED
EMATOLOGIA OSPEDALE CUNEO
Cuneo
ITALY
Local recruitment
Recruiting status:
CLOSED
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO UOC DI EMATOLOGIA
Milano
ITALY/MILANO, ITALY
Local recruitment
Recruiting status:
CLOSED
Participating centers
Information source
Last modification :
July 28, 2025
Current data since :
01 Aug 18:14
Data source :
clinicaltrials.gov