Registry for patients with Chronic Myeloid Leukemia who stop treatment
Observational Study in Adult Patient With Chronic Myeloid Leukemia Who Discontinue Tyrosine Kinase Inhibitors in Italy
University of Turin, Italy · NCT04769947
This study is looking to see if patients with Chronic Myeloid Leukemia can safely stop their medication and stay healthy without it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Turin, Italy (other) |
| Locations | 1 site (Turin) |
| Trial ID | NCT04769947 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect and analyze data from Italian patients with Philadelphia-positive chronic phase Chronic Myeloid Leukemia (CP-CML) who have discontinued Tyrosine Kinase Inhibitors (TKIs). The study includes both retrospective and prospective cohorts, gathering clinical data from existing medical records as well as new data from patients who stop TKI therapy. The goal is to assess the feasibility and safety of treatment-free remission in this patient population. Participants will not undergo any additional procedures outside of standard clinical practice.
Who should consider this trial
Good fit: Ideal candidates are patients with CP-CML who have achieved a deep molecular response and have discontinued TKI therapy.
Not a fit: Patients who have not achieved a deep molecular response or are still undergoing TKI treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of treatment-free remission for patients with CP-CML.
How similar studies have performed: Other studies have shown promising results regarding treatment-free remission in CP-CML, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with CP-CML, treated with TKI monotherapy or TKI in association with other drugs (such as interferon, BCR-ABL1 peptidic vaccine and others) * Treatment with TKI discontinued for any reason * Deep Molecular Response (DMR), defined as MR4 (BCR-ABL1 ratio ≤ 0.01% with at least 10,000 ABL1 copies), or MR4.5 (BCR-ABL1 ratio ≤ 0.0032% with at least 32,000 ABL1 copies), or MR5 (BCR-ABL1 ratio ≤ 0.001% with at least 100,000 ABL1 copies), confirmed at least three times before TKI discontinuation. In patients who discontinued TKIs before the establishment of molecular standardization, DMR will be defined as a level of BCR-ABL1 transcript undetectable by qPCR or by qualitative PCR, confirmed in at least two controls. * Participant is willing and able to give informed consent for participation in the study Data regarding patients discontinuing in less than DMR (as defined above) will be collected and analysed separately. Exclusion Criteria: * Patients who were diagnosed with accelerated or blastic phase CML will be excluded
Where this trial is running
Turin
- Division of Hematology-AO Mauriziano Hospital, University of Turin — Turin, Italy (RECRUITING)
Study contacts
- Study coordinator: Carmen Fava, MD, PhD
- Email: carmen.fava@unito.it
- Phone: 0115085523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Treatment Free Remission, Chronic Myeloid Leukemia