Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission

Plain-language summary

This study aims to follow the treatment-free remission state, in which the disease stays under control after stopping drug therapy, in patients with chronic myeloid leukemia. Adult patients aged 20 and older who have received long-term tyrosine kinase inhibitor therapy and achieved a deep molecular response (MR4.5) may take part. The study has no assigned phase and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

National Taiwan University Hospital

Start date

8/11/2022

Estimated completion

8/11/2032

Countries

Taiwan

Related genes

Locations

• Taipei, Taiwan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. The participant should be an adult (age ⩾20 years) with CP-CML.
2. The BCR-ABL fusion should be in the form of either e13a2 or e14a2 (p210)
3. The participant should not have documented resistance to a 2nd-generation TKI (Nilotinib or Dasatinib)
4. The participant should have received ≥ 5 years of consecutive treatment with imatinib, or ≥ 4 years of consecutive treatment with a 2nd-generation TKI (Nilotinib or Dasatinib)
5. The participant should have achieved MR4.5 (BCR-ABL ⩽0.0032% IS) or undetectable disease in the peripheral blood or bone marrow, for ≥ 2 years, which is documented on ≥ 4 separate tests performed ≥ 3 months apart.
6. Access to a reliable qPCR-based BCR-ABL test with a sensitivity of detecting of at least MR4.5.

Exclusion Criteria:

1. After evaluation, the participant is deemed to be ineligible by the investigator of this study.
2. The participant has no intention to be recruited into this study.