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

Last updated: May 16, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT05439889
202202074RINB
  • Ages > 20
  • All Genders

Study Summary

In recent years, the goal of stopping drug therapy, also known as treatment-free remission (TFR), is emerging as one of the management goals of chronic myeloid leukemia (CML) therapy. Because there is no available data on Asian patients with CML undergoing tyrosine kinase inhibitor discontinuation (TKI), the investigators plan to recruit chronic phase CML patients with deep treatment response and good medical compliance in Taiwan to evaluate the feasibility, safety and clinical consequences of TKI discontinuation.

Eligibility Criteria

Inclusion

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 withimatinib, or ≥ 4 years of consecutive treatment with a 2nd-generation TKI (Nilotinibor Dasatinib)

  5. The participant should have achieved MR4.5 (BCR-ABL ⩽0.0032% IS) or undetectabledisease in the peripheral blood or bone marrow, for ≥ 2 years, which is documentedon ≥ 4 separate tests performed ≥ 3 months apart.

  6. Access to a reliable qPCR-based BCR-ABL test with a sensitivity of detecting of atleast MR4.5.

Exclusion

Exclusion Criteria:

  1. After evaluation, the participant is deemed to be ineligible by the investigator ofthis study.

  2. The participant has no intention to be recruited into this study.

Study Design

Total Participants: 100
Study Start date:
August 11, 2022
Estimated Completion Date:
August 11, 2032

Study Description

  1. Primary goal: To evaluate the feasibility, safety and clinical consequences of TKI discontinuation in chronic phase CML(CP-CML) patients with deep treatment response and good medical compliance in Taiwan

  2. Molecular response monitoring:

  3. After discontinuation of TKI therapy, participants will receive monthly molecular monitoring of BCR-ABL transcript levels by real-time quantitative polymerase chain reaction (RT-qPCR) for one year, every two months for the second year and every three months thereafter.

  4. If loss of major molecular response (MMR) (BCR-ABL transcript level ⩽ 0.1% IS) is detected at any time point post TKI discontinuation, the participant should receive repeated testing within two weeks. If loss of MMR is confirmed, TKI should be resumed within four weeks

  5. RT-qPCR of BCR-ABL would be ordered every four weeks until MR4 (BCR-ABL transcript level ⩽ 0.01% IS) is re-established, and then every 12 weeks indefinitely.

  6. For patients who fails to achieve MMR again within three months after TKI is re-initiated, BCR-ABL kinase domain mutation testing would be performed

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

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