Chronic Myeloid Leukemia, BCR/ABL-PositiveNCT05439889
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
An observational study of Chronic Myeloid Leukemia, BCR/ABL-Positive, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, BCR/ABL-Positive
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Aug 2022to 11 Aug 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Wen-Chien Chou, MD. PhD., +886-2312-3456 ext. 265997, wchou@ntu.edu.tw
About this study
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.
Read the detailed description
- 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
- Molecular response monitoring:
- 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.
- 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
- 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.
- 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
- Keywords
- Chronic myeloid leukemia, Treatment free remission
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: at week 48 of TKI discontinuation
Treatment-free survival
Measured: 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
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
Measured: 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
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
Measured: 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]
Adverse events (AEs) would be assessed according to the CTCAE v4.03
Measured: Evaluation of AEs would be conducted on an ongoing basis on study until 30 days after the last day of TFR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start11 Aug 2022
- Primary completion11 Aug 2028 (estimated)
- Study completion11 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia, BCR/ABL-PositiveStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439889
- Sponsor's protocol ID
- 202202074RINB
- Status last verified
- May 2024
- First submitted
- 15 Jun 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
- ClinicalTrials.gov ID
- NCT05439889
- Acronym / sponsor ID
- 202202074RINB
- Keywords
- Chronic myeloid leukemia, Treatment free remission
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 11 Aug 2028 (estimated)
- Study completion
- 11 Aug 2032 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
- Molecular response monitoring:
- 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.
- 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
- 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.
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients who were in major molecular response (MMR) without re-initiation of treatment
Time frame: at week 48 of tyrosine kinase inhibitor (TKI) discontinuation
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
5 secondary outcomes
The proportion of patients who were in MR4.5 (BCR-ABL transcript level ⩽0.0032% IS) and off treatment
Time frame: at week 48 of TKI discontinuation
Treatment-free survival
Time frame: 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
Time frame: 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
Time frame: 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]
Time frame: Evaluation of AEs would be conducted on an ongoing basis on study until 30 days after the last day of TFR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, BCR/ABL-Positive, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen-Chien Chou, MD. PhD. (+886-2312-3456 ext. 265997, wchou@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who were in major molecular response (MMR) without re-initiation of treatment (time frame: at week 48 of tyrosine kinase inhibitor (TKI) discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.