Chronic Myelocytic LeukemiaNCT04150471
Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients
An observational study of Chronic Myelocytic Leukemia, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelocytic Leukemia
- What is being tested?
- RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2018to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult CML-CP Ph+ patients with BCR-ABL1 will start frontline dasatinib 100mg QD treatment. Dasatinib monotherapy must have been started within 3 months of CP-CML diagnosis. Patients having BCR-ABL1 transcript level < 10% IS (International Standard) after 3 months of treatment with frontline dasatinib will reduce dasatinib dose to 80mg QD and all of patients must have any grade of adverse events at 3 months.
Who may be able to join
- Adult CML-CP Ph+ (Philadelpia) patients with BCR-ABL1 patients diagnosed within 3 months
- Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN(Upper limit of normal)
- Adequate hepatic function defined as: total bilirubin ≤ 2 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the institutional upper limit of normal (ULN).
- Adequate cardiac function (see exclusion criteria)
- Adequate pulmonary function (see exclusion criteria)
- Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or equal to the institutional lower limit of normal. Subjects with low K, Mg levels, total serum Ca and/or ionized Ca must be replete to allow for protocol entry: Rescreening is permitted in the event of temporary biochemical abnormalities
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- CML-CP Ph+ patients with CHR but with BCR-ABL level < 10% IS after 3 months of frontline dasatinib 100 mg treatment. And currently persisting any grade adverse events to dasatinib 100 mg QD
- ECOG(Eastern Cooperative Oncology Group) performance status 0-2
- Women must not be pregnant
Who cannot join
- Previous diagnosis of accelerated phase or blast crisis
- Documented any major ABL1 mutation
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive dasatinib
- Pulmonary arterial hypertension
- Congenital bleeding disorders
- Prior or concurrent malignancy, except for the following
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- Subject with any anti-CML other than dasatinib
- Subjects with prior stem cell transplantation and/or high dose chemotherapy for CML
- Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
- Subjects who were previously treated with over 100mg at second phase screening
- Subjects who are not tolerable to 80mg at second phase screening
- Patients who are pregnant or breast feeding or likely to become pregnant
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul, 137-701
Sahee Park, MS, +82-2-2258-7622, saheepark@catholic.ac.kr
Dong-Wook Kim, Professor
About this study
Official title: An Open Label, Observational Clinical Study to Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Any Grade of Adverse Events and Early Molecular Response Within 3 Months of Frontline Dasatinib Therapy
This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Subjects will be allocated to 80mg QD based on EMR (Early Molecular Response) achievement and early safety profile following a standard of care approach.
Read the detailed description
Patients will sign the consent forms for screening prior to frontline dasatinib therapy (1st) and the 3 month molecular test date (2nd). The molecular samples will be analyzed in the central lab as part of the screening procedure.
Subjects will be treated for a maximum of 60 months after allocation of the last subject on the assigned regimen (dasatinib 80mg QD), unless disease progression, treatment failure or unacceptable toxicity occurs, the subject withdraws consent, or the study is discontinued by the sponsor. Subjects who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years after allocation of the last subject. All subjects will be followed yearly for progression-free survival and overall survival.
For patients who continue their assigned treatment, safety assessments will be conducted every 6 months and cytogenetic assessment as investigator assessment.
Follow up visits after the last dose of study drug will be required at least every 4 weeks until all study related toxicities resolve to baseline (or CTC Grade ≤ 1), stabilize or are deemed irreversible.
- Conditions
- Chronic Myelocytic Leukemia
- Being tested
- RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA AnalysisOther
Conventional Q-RT-PCR every 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MMR
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
Measured: 12 month
Secondary outcomes (2)
To assess: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Safety
Measured: 12 months
MMR and MR4.5 rates by 5 years
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start18 Oct 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myelocytic LeukemiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Dong-Wook Kim, Seoul St. Mary's Hospital
- Investigators
- Sahee Park, Study director, Cancer Research Institute, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150471
- Sponsor's protocol ID
- DAS-CHANGE
- Status last verified
- Oct 2019
- First submitted
- 20 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cortes JE, Saglio G, Kantarjian HM, Baccarani M, Mayer J, Boque C, Shah NP, Chuah C, Casanova L, Bradley-Garelik B, Manos G, Hochhaus A. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016 Jul 10;34(20):2333-40. doi: 10.1200/JCO.2015.64.8899. Epub 2016 May 23.
PubMed 27217448
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Observational Clinical Study to Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Any Grade of Adverse Events and Early Molecular Response Within 3 Months of Frontline Dasatinib Therapy
- ClinicalTrials.gov ID
- NCT04150471
- Acronym / sponsor ID
- DAS-CHANGE
- Conditions
- Chronic Myelocytic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 4 Nov 2019 (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.
This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Subjects will be allocated to 80mg QD based on EMR (Early Molecular Response) achievement and early safety profile following a standard of care approach.
Detailed description
Patients will sign the consent forms for screening prior to frontline dasatinib therapy (1st) and the 3 month molecular test date (2nd). The molecular samples will be analyzed in the central lab as part of the screening procedure.
Subjects will be treated for a maximum of 60 months after allocation of the last subject on the assigned regimen (dasatinib 80mg QD), unless disease progression, treatment failure or unacceptable toxicity occurs, the subject withdraws consent, or the study is discontinued by the sponsor. Subjects who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years after allocation of the last subject. All subjects will be followed yearly for progression-free survival and overall survival.
For patients who continue their assigned treatment, safety assessments will be conducted every 6 months and cytogenetic assessment as investigator assessment.
Follow up visits after the last dose of study drug will be required at least every 4 weeks until all study related toxicities resolve to baseline (or CTC Grade ≤ 1), stabilize or are deemed irreversible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult CML-CP Ph+ patients with BCR-ABL1 will start frontline dasatinib 100mg QD treatment. Dasatinib monotherapy must have been started within 3 months of CP-CML diagnosis. Patients having BCR-ABL1 transcript level < 10% IS (International Standard) after 3 months of treatment with frontline dasatinib will reduce dasatinib dose to 80mg QD and all of patients must have any grade of adverse events at 3 months.
Key inclusion criteria (9 listed)
- Adult CML-CP Ph+ (Philadelpia) patients with BCR-ABL1 patients diagnosed within 3 months
- Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN(Upper limit of normal)
- Adequate hepatic function defined as: total bilirubin ≤ 2 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the institutional upper limit of normal (ULN).
- Adequate cardiac function (see exclusion criteria)
- Adequate pulmonary function (see exclusion criteria)
Key exclusion criteria (14 listed)
- Previous diagnosis of accelerated phase or blast crisis
- Documented any major ABL1 mutation
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive dasatinib
- Pulmonary arterial hypertension
- Congenital bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA AnalysisConventional Q-RT-PCR every 3 months | Other | – |
Primary outcome
Rate of MMR
Time frame: 12 month
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
2 secondary outcomes
To assess: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 12 months
MMR and MR4.5 rates by 5 years
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Results publication: PubMed 27217448Cortes JE, Saglio G, Kantarjian HM, Baccarani M, Mayer J, Boque C, Shah NP, Chuah C, Casanova L, Bradley-Garelik B, Manos G, Hochhaus A. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016 Jul 10;34(20):2333-40. doi: 10.1200/JCO.2015.64.8899. Epub 2016 May 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sahee Park study director
Cancer Research Institute, The Catholic University of Korea
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 Myelocytic Leukemia, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 Nov 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Wook Kim (+82-2-2258-7030, dwkim@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MMR (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04150471, which also lists 1 linked publication.
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 4 Nov 2019.