Chronic LeukemiaFREE CMLNCT07760311
Feasibility Study to Evaluate a Digital Tool for Monitoring Patients Who Have Discontinued Treatment for Chronic Myeloid Leukemia
A study testing Integration of a digital tool in people with Chronic Leukemia, run by Versailles Hospital at 1 site in France.
Trial summary
The objective of this project is to evaluate, over a 12-month period, the feasibility of integrating a digital tool into the follow-up care of patients with chronic myeloid leukemia who have been off treatment for up to 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leukemia
- What is being tested?
- Integration of a digital tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 18 or older
- Patients with chronic myeloid leukemia who have been off treatment for ≤ 2 years
- Patients with access to a digital device with internet access
- Be enrolled in the social security system
- Have given verbal consent after reviewing the study information sheet
Who cannot join
- Patients who cannot read or understand French;
- Individuals entitled to enhanced protection, namely minors, individuals deprived of their liberty by a judicial or administrative decision, individuals staying in a health or social care facility, adults under legal guardianship, and, finally, patients in emergency situations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CH de Versailles
Le Chesnay, 78150
Laure MORISSET, 0139239785, lmorisset@ght78sud.fr
About this study
The objective of this project is to evaluate, over a 12-month period, the feasibility of integrating a digital tool into the follow-up care of patients with chronic myeloid leukemia who have been off treatment for up to 2 years. Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least:
- once a month, if treatment discontinuation was ≤ 6 months;
- once a quarter, if treatment discontinuation was > 6 months. The usage rate will be assessed and compared to a threshold of 60%; if the rate falls below this threshold, feasibility will be considered insufficient.
- Conditions
- Chronic Leukemia
- Being tested
- Integration of a digital tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integration of a digital toolOther
Integration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Integration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years. Receives: Other: Integration of a digital tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least: - once a month, if treatment interruption is ≤ 6 months; - once a quarter, if treatment interruption is > 6 months.
To evaluate, over a 12-month period, the feasibility of integrating a digital tool into the care of patients with chronic myeloid leukemia
Measured: 12 months
Secondary outcomes (7)
Number of times patients used the device.
Assess how often the device is used.
Measured: 12 months
The number of days between when the blood test is performed and when the IPA and the patient view the results on the device.
Assess the time it takes for the Study Nurse and the patient to access laboratory results.
Measured: 12 months
The frequency with which patients contact the study nurse through the system's communication module.
Evaluate the use of the digital device's data exchange module between the patient and the Study Nurse
Measured: 12 months
Anxiety scores will be assessed at enrollment, at M3, M6, and M12 using the 7-item Generalized Anxiety Disorder Screening Scale (GAD-7) (scores range from 0 to 21).
To study anxiety symptoms and their progression over the course of follow-up.
Measured: 12 months
Changes in the GAD-7 anxiety score (0 to 21) based on the duration of treatment interruption (months) and the frequence
To examine the relationship between changes in anxiety scores based on the duration of treatment interruption and the use of the device.
Measured: 12 months
Patient satisfaction will be assessed using a questionnaire designed specifically for this population, consisting of 9 items (with a score ranging from 0 to 36) and a numerical scale for overall satisfaction ranging from 0 to 10.
Assess patient satisfaction with the digital tool.
Measured: 12 months
The tool's usability will be evaluated using the 10-item System Usability Scale (SUS) (0 to 100).
Evaluate the usability of the digital device.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy JAFFRY, Versailles Hospital
- Investigators
- Cindy JAFFRY, Principal investigator, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760311
- Sponsor's protocol ID
- P25/02_FREE CML
- Other IDs
- 2025-A02577-42
- Acronym
- FREE CML
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate a Digital Tool for Monitoring Patients Who Have Discontinued Treatment for Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07760311
- Acronym / sponsor ID
- FREE CML / P25/02_FREE CML
- Conditions
- Chronic Leukemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Aug 2026 (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 objective of this project is to evaluate, over a 12-month period, the feasibility of integrating a digital tool into the follow-up care of patients with chronic myeloid leukemia who have been off treatment for up to 2 years. Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least:
- once a month, if treatment discontinuation was ≤ 6 months;
- once a quarter, if treatment discontinuation was > 6 months. The usage rate will be assessed and compared to a threshold of 60%; if the rate falls below this threshold, feasibility will be considered insufficient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Integration of a digital toolIntegration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 or older
- Patients with chronic myeloid leukemia who have been off treatment for ≤ 2 years
- Patients with access to a digital device with internet access
- Be enrolled in the social security system
- Have given verbal consent after reviewing the study information sheet
Key exclusion criteria (2 listed)
- Patients who cannot read or understand French;
- Individuals entitled to enhanced protection, namely minors, individuals deprived of their liberty by a judicial or administrative decision, individuals staying in a health or social care facility, adults under legal guardianship, and, finally, patients in emergency situations
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 |
|---|---|---|
| Integration of a digital toolIntegration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years. | Other | Intervention arm |
Primary outcome
Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least: - once a month, if treatment interruption is ≤ 6 months; - once a quarter, if treatment interruption is > 6 months.
Time frame: 12 months
To evaluate, over a 12-month period, the feasibility of integrating a digital tool into the care of patients with chronic myeloid leukemia
7 secondary outcomes
Number of times patients used the device.
Time frame: 12 months
The number of days between when the blood test is performed and when the IPA and the patient view the results on the device.
Time frame: 12 months
The frequency with which patients contact the study nurse through the system's communication module.
Time frame: 12 months
Anxiety scores will be assessed at enrollment, at M3, M6, and M12 using the 7-item Generalized Anxiety Disorder Screening Scale (GAD-7) (scores range from 0 to 21).
Time frame: 12 months
Changes in the GAD-7 anxiety score (0 to 21) based on the duration of treatment interruption (months) and the frequence
Time frame: 12 months
Patient satisfaction will be assessed using a questionnaire designed specifically for this population, consisting of 9 items (with a score ranging from 0 to 36) and a numerical scale for overall satisfaction ranging from 0 to 10.
Time frame: 12 months
The tool's usability will be evaluated using the 10-item System Usability Scale (SUS) (0 to 100).
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Related trials for Chronic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
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.
Cindy JAFFRY principal investigator
Versailles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integration of a digital tool in people with Chronic Leukemia, run by Versailles Hospital at 1 site in France.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure Morisset (+33139239785, lmorisset@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least: - once a month, if treatment interruption is ≤ 6 months; - once a quarter, if treatment interruption is > 6 months. (time frame: 12 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 12 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.