CMLASTNCT05926128
Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase
A study testing Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment in people with CML, run by Fundaleu at 1 site in Argentina.
Trial summary
The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- CML
- What is being tested?
- Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Feb 2019to Jan 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed consent.
- Patients with a diagnosis of CML BCR-ABL positive in CP treated with approved TKI (Imatinib, Nilotinib or Dasatinib) in 1st line or in 2nd line due to intolerance to the 1st line or in 2nd line due to the lack of deep MR with 1st line TKI, which never presented criteria for treatment failure.
- Age ≥ 18 years
- ≥ 4 years of treatment with imatinib, nilotinib or dasatinib.
- Achievement of MR 4.5 in a standardized laboratory (BCR-ABL1 IS ≤ 0.0032%).
- Evidence of MR 4.5 sustained for ≥ 2 years, as documented in at least 4 tests performed at least 3 months apart.
- Evidence of typical quantifiable BCR-ABL1 transcript (b3a2 [e14a2] and / or b2a2 [e13a2], typical isoforms of p210).
Who cannot join
- Patients who previously discontinued TKI and demonstrated recurrence of the disease.
- Patients with failure to any TKI at any time.
- Patients who presented accelerated phase or CML in blast crisis at any time.
- Patients with atypical transcript not quantifiable by RT qPCR
- BCR-ABL mutation detected at any time during the course of the resistant disease
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
FUNDALEU
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1114
Carolina Pavlovsky, MD, +541148771070, cpavlovsky@fundaleu.org.ar
Mariana Juni, +541148771070, mjuni@fundaleu.org.ar
About this study
Official title: Prospective Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Achieved Deep Molecular Response With Tyrosine Kinase Inhibitors in Real Life Setting in Argentina - (Argentine Stop Trial)
The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. The second aim is to characterize the immunological status of patients with CML at the time of TKI interruption and then at 3 months after the interruption.
Read the detailed description
ARGENTINA STOP TRIAL is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase Chronic Myeloid Leukemia (CML) in Deep Molecular Response after stopping Tyrosine Kinase Inhibitor (TKI)
Primary Objective:
- To identify the proportion of patients who continue on Major Molecular Response after discontinuing treatment with TKI.
Secondary objectives:
- To characterize the immunological status of patients with CML at the time of interruption and then at 3 and 12 months after the interruption.
Tertiary objective: To evaluate the pharmacoeconomic impact of interrupting the treatment.
- Conditions
- CML
- Being tested
- Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
- Keywords
- DISCONTINUATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolmentDrug
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24.
| Study group | Role | What they receive |
|---|---|---|
| CML patient TKI discontinuation study | Other | Treatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors Receives: Drug: Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular relapse free survival during 24 months
Molecular relapse free survival, defined as the time from the start of TKI interruption until the loss of the MMR.
RQ PCR (IS) >0.1% BCR ABL will be considered as loss of MMR
Measured: 24 months
Secondary outcomes (1)
Treatment-free survival during 24 months
Treatment-free survival , defined as the time from the start of TKI interruption to the restart of the TKI.
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 posted3 Jul 2023
- Study start1 Feb 2019
- Primary completion1 Jun 2022
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMLStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multicentre, open-label, uncontrolled trial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundaleu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Pavlovsky, Fundaleu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926128
- Sponsor's protocol ID
- Argentina Stop Trial
- Other IDs
- AST2018
- Acronym
- AST
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Achieved Deep Molecular Response With Tyrosine Kinase Inhibitors in Real Life Setting in Argentina - (Argentine Stop Trial)
- ClinicalTrials.gov ID
- NCT05926128
- Acronym / sponsor ID
- AST / Argentina Stop Trial
- Conditions
- CML
- Keywords
- DISCONTINUATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- FundaleuUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 3 Jul 2023 (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.
The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. The second aim is to characterize the immunological status of patients with CML at the time of TKI interruption and then at 3 months after the interruption.
Detailed description
ARGENTINA STOP TRIAL is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase Chronic Myeloid Leukemia (CML) in Deep Molecular Response after stopping Tyrosine Kinase Inhibitor (TKI)
Primary Objective:
- To identify the proportion of patients who continue on Major Molecular Response after discontinuing treatment with TKI.
Secondary objectives:
- To characterize the immunological status of patients with CML at the time of interruption and then at 3 and 12 months after the interruption.
Tertiary objective: To evaluate the pharmacoeconomic impact of interrupting the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multicentre, open-label, uncontrolled trial
| Arm | Type | Receives |
|---|---|---|
| CML patient TKI discontinuation study | Other | Drug: Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolmentTreatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed consent.
- Patients with a diagnosis of CML BCR-ABL positive in CP treated with approved TKI (Imatinib, Nilotinib or Dasatinib) in 1st line or in 2nd line due to intolerance to the 1st line or in 2nd line due to the lack of deep MR with 1st line TKI, which never presented criteria for treatment failure.
- Age ≥ 18 years
- ≥ 4 years of treatment with imatinib, nilotinib or dasatinib.
- Achievement of MR 4.5 in a standardized laboratory (BCR-ABL1 IS ≤ 0.0032%).
Key exclusion criteria (5 listed)
- Patients who previously discontinued TKI and demonstrated recurrence of the disease.
- Patients with failure to any TKI at any time.
- Patients who presented accelerated phase or CML in blast crisis at any time.
- Patients with atypical transcript not quantifiable by RT qPCR
- BCR-ABL mutation detected at any time during the course of the resistant disease
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 |
|---|---|---|
| Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolmentDiscontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24. | Drug | CML patient TKI discontinuation study |
Primary outcome
Molecular relapse free survival during 24 months
Time frame: 24 months
Molecular relapse free survival, defined as the time from the start of TKI interruption until the loss of the MMR. RQ PCR (IS) >0.1% BCR ABL will be considered as loss of MMR
1 secondary outcome
Treatment-free survival during 24 months
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 3 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for CML
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment in people with CML, run by Fundaleu at 1 site in Argentina.
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 7 inclusion and 5 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 3 Jul 2023. 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 Argentina. 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 Carolina Pavlovsky, MD (+541148771070, cpavlovsky@fundaleu.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular relapse free survival during 24 months (time frame: 24 months). 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 3 Jul 2023.