Leukemia, Myeloid, Chronic-PhaseNCT03239886
Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
A study testing imatinib discontinuation in people with Leukemia, Myeloid, Chronic-Phase, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic-Phase
- What is being tested?
- imatinib discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Dec 2016to 31 Jan 2020
- Phase
- Interventional
- 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
Who may be able to join
- Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria
- Treatment with imatinib for at least 36 months
- BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months
Who cannot join
- Previous allogeneic stem cell transplantation
- Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib
- Imatinib dose escalation at any time, due to loss or inadequate response
- BCR-ABL mutation
- IS: International Scale
- MR4log: molecular response of 4log or <0,1% (IS)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica da Hematologia do HCFMUSP
São Paulo, São Paulo
About this study
This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.
Read the detailed description
Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost during the study or if the subject withdraw the informed consenting.
The primary objective is to measure the number of subject that sustain the major molecular response (RM3log or BCR-ABL level below 0.1%) after 2 years of follow-up.
BCR: breakpoint cluster region
ABL: abelson murine leukemia
RM3log: major molecular response, BCR-ABL level below 0.1% (IS)
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Being tested
- imatinib discontinuation
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib discontinuationOther
imatinib discontinuation
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation | Experimental | All subjects will discontinue imatinib Receives: Other: imatinib discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects that remain with RM3log after imatinib discontinuation
Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up.
Measured: 24 months
Secondary outcomes (3)
Number of subjects that recover MR3log after imatinib reintroduction
In the population that do not sustain BCR-ABL below 0,1% during the study, the time to recover the response after imatinib reintroduction will be measured
Measured: 6 months
Analysis of immunological profile of all subjects
Study of lymphocytes population by flow cytometry, including NK and T population
Measured: 24 months
Safety and tolerability of imatinib discontinuation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start15 Dec 2016
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Jan 2020 (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 Leukemia, Myeloid, Chronic-PhaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm study; all patients will discontinue imatinib (intervention)
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239886
- Sponsor's protocol ID
- 15418
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seguro FS, Maciel FVR, Santos FM, Abdo ANR, Pereira TDM, Nardinelli L, Rocha V, Bendit I. MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial. Leuk Res. 2021 Feb;101:106516. doi: 10.1016/j.leukres.2021.106516. Epub 2021 Jan 21.
PubMed 33517185
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
- ClinicalTrials.gov ID
- NCT03239886
- Acronym / sponsor ID
- 15418
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 4 Aug 2017 (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 will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.
Detailed description
Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost during the study or if the subject withdraw the informed consenting.
The primary objective is to measure the number of subject that sustain the major molecular response (RM3log or BCR-ABL level below 0.1%) after 2 years of follow-up.
BCR: breakpoint cluster region
ABL: abelson murine leukemia
RM3log: major molecular response, BCR-ABL level below 0.1% (IS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm study; all patients will discontinue imatinib (intervention)
| Arm | Type | Receives |
|---|---|---|
| Discontinuation | Experimental | Other: imatinib discontinuationAll subjects will discontinue imatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria
- Treatment with imatinib for at least 36 months
- BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months
Key exclusion criteria (6 listed)
- Previous allogeneic stem cell transplantation
- Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib
- Imatinib dose escalation at any time, due to loss or inadequate response
- BCR-ABL mutation
- IS: International Scale
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 |
|---|---|---|
| imatinib discontinuationimatinib discontinuation | Other | Discontinuation |
Primary outcome
Number of subjects that remain with RM3log after imatinib discontinuation
Time frame: 24 months
Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up.
3 secondary outcomes
Number of subjects that recover MR3log after imatinib reintroduction
Time frame: 6 months
Analysis of immunological profile of all subjects
Time frame: 24 months
Safety and tolerability of imatinib discontinuation
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Derived from this study: PubMed 33517185Seguro FS, Maciel FVR, Santos FM, Abdo ANR, Pereira TDM, Nardinelli L, Rocha V, Bendit I. MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial. Leuk Res. 2021 Feb;101:106516. doi: 10.1016/j.leukres.2021.106516. Epub 2021 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imatinib discontinuation in people with Leukemia, Myeloid, Chronic-Phase, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 6 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 23 Mar 2018. 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 Brazil. 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?
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?
Number of subjects that remain with RM3log after imatinib discontinuation (time frame: 24 months). 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 NCT03239886, 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 23 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.