Chronic Myeloid LeukemiaPhase 2READITNCT04578847
A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)
A Phase 2 study testing Imatinib, Nilotinib and Dasatinib in people with Chronic Myeloid Leukemia and Chronic Myeloid Leukemia in Remission, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial summary
The main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Myeloid Leukemia in Remission, BCR-ABL Positive Chronic Myelogenous Leukemia
- What is being tested?
- Imatinib, Nilotinib and Dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2020to 15 Jan 2025
- Phase
- Phase 2
- 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
- CML in chronic phase.
- TKI treatment for at least 3 years.
- DMR (BCR-ABL≤0.01%) for at least 1 year, MMR (BCR-ABL≤0.1%) for at least 2 years
- At least 3 molecular results over the preceding 24 months, which confirm the presence of MMR and DMR
- Written Informed Consent
- CML patients with DMR for at least 1 years and MMR for at least 2 years after STOP TKI in anamnesis.
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- For patients who are on the reduced dose TKI (1 stage) at the time of inclusion in the study
- 1. The duration of therapy at reduced doses of TKI phase I is at least 6 months.
- For patients on the reduced dose TKI (2 stage, before TFR phase) at the time of inclusion in the study
- DMR (BCR-ABL≤0.01%) for at least 2 years
- The duration of therapy at reduced doses of TKI phase 1 is for at least 6 months, the total duration of therapy at reduced doses is for at least 12 months.
Who cannot join
- Age under 18
- ECOG >2
- CML in accelerated phase or blast crisis at any time
- Lack of Written Informed Consent
- Pregnant or lactating women
- Incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Non-randomized Stratified Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib) in Adults With Ph+ Chronic Myeloid Leukemia With Stable Deep Molecular Response
The main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib.
Read the detailed description
The duration of the dose reduction phase will be 12 months. This phase will have two stage of 6 months, respectively.
The dose of imatinib, nilotinib, dasatinib or bosutinib will be reduced by 25-50% on the first stage, and by another 25% on the second stage.
- The initial dose of imatinib will be 400 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.
- The initial dose of nilotinib will be 300 or 400 mg twice daily. The dose will be reduced by 400 mg daily on the first stage, by 200 mg daily - on the second stage.
- The initial dose of dasatinib will be 100 or 140 mg daily. The dose will be reduced by 50 mg daily on the first stage, by 25 mg daily - on the second stage.
- The initial dose of bosutinib will be 500 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.
All patients with stable deep molecular response (at least 2 years) will be included in treatment free remission phase (TFR-phase). The duration of TFR-phase will be 24 months.
The CML patients can enter the study already on reduced doses TKI, if they will meet the inclusion criteria.
It is possible to include patients, who have already received therapy with reduced doses of TKI. The duration of TKI therapy with reduced doses of 1 stage should be at least 6 months, if TKI doses meet of stage 1. The duration of TKI therapy with reduced doses of 2 stage should be for at least 6 months and the general duration of TKI therapy with reduced doses should be for at least 12 months, if TKI doses meet of stage 2.
- Conditions
- Chronic Myeloid Leukemia, Chronic Myeloid Leukemia in Remission, BCR-ABL Positive Chronic Myelogenous Leukemia
- Being tested
- Imatinib, Nilotinib, Dasatinib, Bosutinib
- Keywords
- chronic myeloid leukimea, tyrosine kinase inhibitors, the TKI dose reduction, discontinuation treatment TKI, imatinib, nilotinib, dasatinib, bosutinib
- 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.
ImatinibDrug
Initial dose - 400 mg daily. If on imatinib, the dose should be decreased to 300 mg daily on the first stage, to 200 mg daily - on the second stage.
NilotinibDrug
Initial dose - 300 or 400 mg twice daily. If on nilotinib to 400mg daily on the first stage, to 200 mg daily - on the second stage.
DasatinibDrug
Initial dose 100 or 140 mg daily. If on dasatinib then to 50 mg daily on the first stage, to 25 mg daily - on the second stage.
BosutinibDrug
Initial dose 500 mg daily. If on bosutinib, the dose should be reduced to 300 mg daily on the first stage, to 200 mg daily on the second stage.
| Study group | Role | What they receive |
|---|---|---|
| The TKI dose reduction | Experimental | Imatinib, nilotinib, dasatinib or bosutinib; the two stage of TKI dose reduction phase for 12 months (6 months and 6 months, respectively). Receives: Drug: Imatinib; Drug: Nilotinib; Drug: Dasatinib; Drug: Bosutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival, survival without molecular relapse
Measured: 37 months
Secondary outcomes (9)
The proportion of patients with molecular relapse who achieved MMR and DMR after the resumption TKI therapy in standard doses
Measured: 37 months
The proportion of patients who resolved the adverse events after TKI dose reduction and discontinuation of TKI therapy
Measured: 37 months
The proportion of patients who have TKI withdrawal syndrome after TKI dose reduction and discontinuation of TKI therapy.
Measured: 37 months
Clinical factors, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
sex (male, female)
Measured: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
age
Measured: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
risk group (Sokal, ELTS) at the time of diagnosis
Measured: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
duration of previous TKI treatment
Measured: 37 months
Biological factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Duration of molecular response
Measured: 37 months
Biological factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Molecular response at the time of inclusion in the study
Measured: 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Jan 2020
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Anna Turkina, Professor, Principal investigator, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578847
- Sponsor's protocol ID
- READIT-2020
- Acronym
- READIT
- Status last verified
- Oct 2020
- First submitted
- 5 Mar 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-randomized Stratified Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib) in Adults With Ph+ Chronic Myeloid Leukemia With Stable Deep Molecular Response
- ClinicalTrials.gov ID
- NCT04578847
- Acronym / sponsor ID
- READIT / READIT-2020
- Conditions
- Chronic Myeloid Leukemia, Chronic Myeloid Leukemia in Remission, BCR-ABL Positive Chronic Myelogenous Leukemia
- Keywords
- chronic myeloid leukimea, tyrosine kinase inhibitors, the TKI dose reduction, discontinuation treatment TKI, imatinib, nilotinib, dasatinib, bosutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 8 Oct 2020 (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 main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib.
Detailed description
The duration of the dose reduction phase will be 12 months. This phase will have two stage of 6 months, respectively.
The dose of imatinib, nilotinib, dasatinib or bosutinib will be reduced by 25-50% on the first stage, and by another 25% on the second stage.
- The initial dose of imatinib will be 400 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.
- The initial dose of nilotinib will be 300 or 400 mg twice daily. The dose will be reduced by 400 mg daily on the first stage, by 200 mg daily - on the second stage.
- The initial dose of dasatinib will be 100 or 140 mg daily. The dose will be reduced by 50 mg daily on the first stage, by 25 mg daily - on the second stage.
- The initial dose of bosutinib will be 500 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.
All patients with stable deep molecular response (at least 2 years) will be included in treatment free remission phase (TFR-phase). The duration of TFR-phase will be 24 months.
The CML patients can enter the study already on reduced doses TKI, if they will meet the inclusion criteria.
It is possible to include patients, who have already received therapy with reduced doses of TKI. The duration of TKI therapy with reduced doses of 1 stage should be at least 6 months, if TKI doses meet of stage 1. The duration of TKI therapy with reduced doses of 2 stage should be for at least 6 months and the general duration of TKI therapy with reduced doses should be for at least 12 months, if TKI doses meet of stage 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The TKI dose reduction | Experimental | Drug: Imatinib, Drug: Nilotinib, Drug: Dasatinib, Drug: BosutinibImatinib, nilotinib, dasatinib or bosutinib; the two stage of TKI dose reduction phase for 12 months (6 months and 6 months, respectively). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- CML in chronic phase.
- TKI treatment for at least 3 years.
- DMR (BCR-ABL≤0.01%) for at least 1 year, MMR (BCR-ABL≤0.1%) for at least 2 years
- At least 3 molecular results over the preceding 24 months, which confirm the presence of MMR and DMR
- Written Informed Consent
Key exclusion criteria (6 listed)
- Age under 18
- ECOG >2
- CML in accelerated phase or blast crisis at any time
- Lack of Written Informed Consent
- Pregnant or lactating women
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 |
|---|---|---|
| ImatinibInitial dose - 400 mg daily. If on imatinib, the dose should be decreased to 300 mg daily on the first stage, to 200 mg daily - on the second stage. | Drug | The TKI dose reduction |
| NilotinibInitial dose - 300 or 400 mg twice daily. If on nilotinib to 400mg daily on the first stage, to 200 mg daily - on the second stage. | Drug | The TKI dose reduction |
| DasatinibInitial dose 100 or 140 mg daily. If on dasatinib then to 50 mg daily on the first stage, to 25 mg daily - on the second stage. | Drug | The TKI dose reduction |
| BosutinibInitial dose 500 mg daily. If on bosutinib, the dose should be reduced to 300 mg daily on the first stage, to 200 mg daily on the second stage. | Drug | The TKI dose reduction |
Primary outcome
Overall survival, survival without molecular relapse
Time frame: 37 months
9 secondary outcomes
The proportion of patients with molecular relapse who achieved MMR and DMR after the resumption TKI therapy in standard doses
Time frame: 37 months
The proportion of patients who resolved the adverse events after TKI dose reduction and discontinuation of TKI therapy
Time frame: 37 months
The proportion of patients who have TKI withdrawal syndrome after TKI dose reduction and discontinuation of TKI therapy.
Time frame: 37 months
Clinical factors, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Time frame: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Time frame: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Time frame: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Time frame: 37 months
Biological factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Time frame: 37 months
Biological factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Time frame: 37 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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.
Anna Turkina, Professor principal investigator
National Research Center for Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib, Nilotinib and Dasatinib in people with Chronic Myeloid Leukemia and Chronic Myeloid Leukemia in Remission, run by National Research Center for Hematology, Russia at 1 site in Russia.
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 11 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 8 Oct 2020. 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 Russia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall survival, survival without molecular relapse (time frame: 37 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 8 Oct 2020.