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

NCT05439889 | Recruiting

• 1 other identifier: 202202074RINB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Myeloid Leukemia, BCR/ABL-Positive

Keywords

Chronic myeloid leukemia; Treatment free remission

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who were in major molecular response (MMR) without re-initiation of treatment

  Real-time quantitative polymerase chain reaction (RT-qPCR) would be done to determined the transcript level of BCR-ABL fusion gene in peripheral blood samples

  at week 48 of tyrosine kinase inhibitor (TKI) discontinuation

Secondary Outcomes (5)

• The proportion of patients who were in MR4.5 (BCR-ABL transcript level ⩽0.0032% IS) and off treatment

  at week 48 of TKI discontinuation

• Treatment-free survival

  From the start of TKI discontinuation until the earliest occurrence of any of the following: loss of MMR, restart of TKI for any reason, progression to accelerated phase/blast phase, or death of any cause, assessed up to 60 months

• The proportion of patients who reachieved of MMR after TKI restart

  qPCR of BCR-ABL would be checked every four weeks until MR4 is re-established, and then every 12 weeks until study completion (week 240).

• The proportion of patients who reachieved of MR4.5 after TKI restart

  qPCR of BCR-ABL would be checked every four weeks until MR4 is re-established, and then every 12 weeks until study completion (week 240).

• Incidence and severity of treatment-related adverse events [Safety and Tolerability]

  Evaluation of AEs would be conducted on an ongoing basis on study until 30 days after the last day of TFR

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with CP-CML and are regularly followed up at National Taiwan University Hospital (NTUH) or at the branch hospitals of the NTUH healthcare system

You may qualify if:

• The participant should be an adult (age ⩾20 years) with CP-CML.
• The BCR-ABL fusion should be in the form of either e13a2 or e14a2 (p210)
• The participant should not have documented resistance to a 2nd-generation TKI (Nilotinib or Dasatinib)
• 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)
• 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.
• Access to a reliable qPCR-based BCR-ABL test with a sensitivity of detecting of at least MR4.5.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wen-Chien Chou, MD. PhD.

CONTACT

+886-2312-3456; wchou@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 30, 2022
• Study Start: August 11, 2022
• Primary Completion (Estimated): August 11, 2028
• Study Completion (Estimated): August 11, 2032
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

TW (1)