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TFR-PRO

Retro-prospective observational study on risk of progression in cp-cml patients eligible for tki discontinuation
Source : Import from center

clinicaltrials.gov reference: NCT04621851
Recruiment closed
Last modification : 2025/07/28
Study type

Observational


Target population

Medical condition (targeted specialty)

Data not available

Participants profils

Participants gender(s)

ALL

Source : Import from center

Selection criterias

Inclusion criteria

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

Source : Import from center

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
    Prospective cohort
    Recruitment status
    unknown
    Retrospective/Prospective cohort
    Recruitment status
    unknown
    Current data since : July 28, 2025 20:00

    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

    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

    Last modification : July 28, 2025
    Current data since : 01 Aug 18:14
    Data source : clinicaltrials.gov
    clinicaltrials.gov reference: NCT04621851