Chronic Myelocytic LeukemiaNCT02975115
Evaluating True PCR-negative Rate of Frontline Dasatinib in Early Chronic Phase CML for Therapeutic Harmonization
An observational study of Chronic Myelocytic Leukemia, run by Seoul St. Mary's Hospital.
Trial summary
This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a complete molecular response and to prove a possibility of "Operational Cure" in CMR patients. 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 RNA Analysis
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jan 2018
- 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: Newly diagnosed, CP-CML patients ≥ 18 years of age. Use of dasatinib for less than three weeks prior to study entry is allowed. Adult patients with a molecularly confirmed diagnosis of BCR-ABL positive CML in new CP who have not been treated with any myeloablative or interferon alpha therapy.
Who may be able to join
- Patients must have Ph+ CML in CP
- newly diagnosed chronic phase CML, except hydroxyurea, anagrelide and within 7 days imatinib treatment
- Subjects must be enrolled in this study within approximately 3 months (90 days) after the date of first being diagnosed with CML. Subjects are allowed to have clonal chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible
- 0-2 ECOG Performance Status (PS) Score
- Adequate hepatic function test
- Adequate renal function test
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- Adequate other organ functions
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
- Subjects agree to sign informed consent
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 1 month (4 weeks) after the last dose of study medication.
- WOCBP using a prohibited contraceptive method (Not applicable for this study).
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test at enrollment or prior to administration of study medication.
- Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) after completion of study medication.
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
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- Known pleural effusion at baseline.
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML
- Prior chemotherapy for peripheral stem cell mobilization. (Prior collection of un-mobilized peripheral blood stem cells is permitted).
- Prior or concurrent malignancy
- Evidence of digestive dysfunction that would prevent administration of study therapy by mouth
- Uncontrolled diabetes
About this study
Official title: The Catholic University of Korea Cancer Research Institute
This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a complete molecular response and to prove a possibility of "Operational Cure" in CMR patients.
Read the detailed description
This study also examines kinetics of complete molecular responses using new highly sensitive PCR based technology, digital PCR, which is reported to have a sensitivity down to 6 log reduction.
- Conditions
- Chronic Myelocytic Leukemia
- Being tested
- RQ-PCR 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 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 CMR(complete molecular response)
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
Measured: 36 month
Secondary outcomes (1)
Rate of MMR(major molecular response)
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
Measured: 3,6,12,24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2013
- Primary completionNov 2016
- Study completionJan 2018 (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
- Enrolment
- 102 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975115
- Sponsor's protocol ID
- PCR-DEPTH
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Goh HG, Lin M, Fukushima T, Saglio G, Kim D, Choi SY, Kim SH, Lee J, Lee YS, Oh SM, Kim DW. Sensitive quantitation of minimal residual disease in chronic myeloid leukemia using nanofluidic digital polymerase chain reaction assay. Leuk Lymphoma. 2011 May;52(5):896-904. doi: 10.3109/10428194.2011.555569. Epub 2011 Feb 21.
PubMed 21338281
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Catholic University of Korea Cancer Research Institute
- ClinicalTrials.gov ID
- NCT02975115
- Acronym / sponsor ID
- PCR-DEPTH
- Conditions
- Chronic Myelocytic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2018 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- 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 designed to confirm the efficacy of dasatinib 100mg once daily in producing a complete molecular response and to prove a possibility of "Operational Cure" in CMR patients.
Detailed description
This study also examines kinetics of complete molecular responses using new highly sensitive PCR based technology, digital PCR, which is reported to have a sensitivity down to 6 log reduction.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed, CP-CML patients ≥ 18 years of age. Use of dasatinib for less than three weeks prior to study entry is allowed. Adult patients with a molecularly confirmed diagnosis of BCR-ABL positive CML in new CP who have not been treated with any myeloablative or interferon alpha therapy.
Key inclusion criteria (10 listed)
- Patients must have Ph+ CML in CP
- newly diagnosed chronic phase CML, except hydroxyurea, anagrelide and within 7 days imatinib treatment
- Subjects must be enrolled in this study within approximately 3 months (90 days) after the date of first being diagnosed with CML. Subjects are allowed to have clonal chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible
- 0-2 ECOG Performance Status (PS) Score
- Adequate hepatic function test
Key exclusion criteria (13 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 1 month (4 weeks) after the last dose of study medication.
- WOCBP using a prohibited contraceptive method (Not applicable for this study).
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test at enrollment or prior to administration of study medication.
- Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) after completion of study medication.
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 RNA AnalysisConventional Q-RT-PCR every 3 months | Other | – |
Primary outcome
Rate of CMR(complete molecular response)
Time frame: 36 month
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
1 secondary outcome
Rate of MMR(major molecular response)
Time frame: 3,6,12,24 and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Results publication: PubMed 21338281Goh HG, Lin M, Fukushima T, Saglio G, Kim D, Choi SY, Kim SH, Lee J, Lee YS, Oh SM, Kim DW. Sensitive quantitation of minimal residual disease in chronic myeloid leukemia using nanofluidic digital polymerase chain reaction assay. Leuk Lymphoma. 2011 May;52(5):896-904. doi: 10.3109/10428194.2011.555569. Epub 2011 Feb 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myelocytic Leukemia, run by Seoul St. Mary's Hospital.
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 10 inclusion and 13 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CMR(complete molecular response) (time frame: 36 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 NCT02975115, 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 29 Nov 2016.