Italian Treatment Free Remission Registry

Launched by UNIVERSITY OF TURIN, ITALY · Feb 22, 2021

Keywords

ClinConnect Summary

The Italian Treatment Free Remission Registry is a clinical trial designed to study patients with a type of blood cancer called Chronic Myeloid Leukemia (CML) who have stopped their treatment with targeted therapy medications known as TKIs. The main goal of the study is to gather information about how well these patients do after stopping treatment, especially in terms of staying healthy and free from cancer progression. Researchers want to learn more about the safety of long-term treatment and the experiences of patients who decide to discontinue their TKIs, which is becoming more common in practice.

To be eligible for this trial, participants need to have a specific phase of CML called chronic phase and must have previously received TKI treatment, either alone or with other medications. They must also have shown a significant response to treatment before stopping. This response is measured using specific tests that check for low levels of cancer-related markers in the blood. Throughout the trial, participants will be monitored to collect important data about their health after stopping treatment. It’s worth noting that patients in more advanced stages of CML will not be included in this study. If you or a loved one are considering participating, it’s essential to discuss this opportunity with a healthcare provider.

Gender

ALL

Eligibility 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