Chronic Myeloid LeukemiaKIWISNCT03996096
Tyrosine Kinase Inhibitor Withdrawal Syndrome in CML Patients: Observatory Trial Studying the Biological Factors.
An observational study of Chronic Myeloid Leukemia and Tyrosine Kinase Inhibitor, run by University Hospital, Caen at 1 site in France.
Trial summary
Patients who suffer from chronic myeloid leukemia are treated by tyrosin kinase inhibitors (TKI) saying imatinib, nilotinib, dasatinib, bosutinib and ponatinib. These drugs are highly efficient with excellent response allowing some patients to definitely stop their cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Tyrosine Kinase Inhibitor, Withdrawal Syndrome
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2019to 16 Mar 2023
- 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: This study concerns patients suffering from Chronic myeloid leukemia treated with TKI (Imatinib, Nilotinib, dasatinib, bosutinib or Ponatinib) for at least 5 years with deep molecular response (MR4) for at least 2 years who agree to stop their drug. Other situation of TKI discontinuation. Five cities are participating in the study: CHU de Caen, CHU d'Amiens, CHU de Clermont-Ferrand, Centre Henri Becquerel de Rouen et le CH de Valenciennes.
Who may be able to join
- Adult CML patient candidate for TKI discontinuation.
- Performans status : 0-2
- Patient provided with information
Who cannot join
- Patient unable to fulfill the questionnaires
- Patient suffering from demantia
- Patient treated with any cytokine antagonist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Observationnelle Biologique Sur le Syndrome de Sevrage Des Inhibiteurs de Tyrosine Kinase Dans la Leucémie Myéloïde Chronique.
Patients who suffer from chronic myeloid leukemia are treated by tyrosin kinase inhibitors (TKI) saying imatinib, nilotinib, dasatinib, bosutinib and ponatinib. These drugs are highly efficient with excellent response allowing some patients to definitely stop their cancer treatment. However, in 30% of cases, when the treatment is stopped, pains could arise in shoulders, hips, joints… These symptoms occurring after the withdrawal of a drug are odd and biologically unexplained so far. This study seeks to discover the biological factors behind these symptoms called 'TKI withdrawal syndrome' by the scientific community.
Read the detailed description
The success of TKI in the treatment of chronic myeloid leukemia is undeniable. Indeed, since the advent of imatinib in 2000 and the subsequent 4 other TKIs, this once fatal disease has become just another chronic disease with patient life expectancy close to the general population. Lifelong TKI therapy offers an 'operational cure' which means quiescent BCR-ABL leukemic stem cells are not eradicated but only controlled.
This statement was challenged in 2008 by the French 'STIM' study in which patients with undetectable BCR-ABL were proposed to discontinue their imatinib: 40% of these patients successfully achieved treatment free remission (TFR) with no recurrence of the disease. These figures are confirmed by the Australian 'TWISTER' study. The resumption of Imatinib therapy was triggered by the positivity of BCR-ABL. In the A-STIM study, the loss of major molecular response is the main criteria to resume imatinib. Accordingly, TFR was a success in 60% of patients. Similar figures was published with second generation TKIs with the same criteria.
In the light of these studies, it is clear that the fields have moved to a more ambitious goal than the operational cure, without the need for remaining on TKI.
Paradoxically, a new syndrome emerged from the Sweden group in 2014: 'the TKI withdrawal syndrome. It consisted of musculoskeletal pains resembling the Polymyalgia Rheumatica in CML patients after discontinuation of Imatinib. It occurred within 6 weeks in 30% of the patients who went on stopping imatinib. Patients with severe pain responded to 10-20 mg of prednisolone. Similar manifestations were described in the European 'EuroSki' study. No explanation was found.
It is well known that TKIs have off-target effects. In addition to BCR-ABL, they inhibit c-Kit, SRC, PDGFR, BTK, TEC, NFKB pathways resulting in anti-inflammatory effects. They can also cause disturbances in electrolyte balance (hypophosphatemia) and bone metabolism. Some research teams have correlated the success of TFR to the increase in cytotoxic NK cells and production IFN and TNFα.
Is the TKI withdrawal syndrome a rebound phenomenon from these off-target effects with excessive release of some cytokines? Of note, an Italian team showed in 4 out of 8 patients with WS an increase of PDGFβ (in 1 patient there was also increase in IL6, TGFβ and VEGF). But no tests were performed in the other patients who stopped TKI and did not presented with the WS as comparison.
Here, the proposed study concerns any CML patient candidate for TKI discontinuation. Will prospectively be checked a number of cytokines and biological factors susceptible to contribute to the clinical features taking into account the off-target effects of TKIs. Therefore, the investigators could compare the variation in a potentially involved cytokine within patients with or without withdrawal syndrome. In addition, the study will prospectively provide a broader description of TKI WS using Brief pain Inventory (BPI) questionnaire.
Eventually, cytokines, inflammatory and bone markers will be dosed at diagnosis and every month during 3 months corresponding to the timeframe in which the withdrawal syndrome is due to occur. A variation of 20% (increase or decrease) in whatever marker(s) will be considered significant if it is (or they are) observed in the group with "TKI withdrawal (TKI WS)" but not in the group without "TKI WS". Pathophysiological explanation of this syndrome could be assumed later taking into account the clinical presentation partly explored by the pain questionnaires
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group with the TKI withdrawal syndrome | There is no intervention. Patients will stop their tyrosine kinase inhibitor yielding to 2 subsets: patients with or without the TKI withdrawal syndrome. | |
| Group without the TKI withdrawal syndrome | As abovementioned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of cytokines:
Measurement of cytokines: A variation of 20% in a given marker will be significant if it is observed in the group with "TKI WS" but not in the group without "TKI WS". Of note, the patient will be his own witness.
. In picogram/milliliter (pg/ml): IL2,IL 6, IL10, IL15, TGFβ,TNFα, IFNγ, VEGF, PDGFβ,
Measured: at diagnosis and every month during 3 months
Measurement of cytokines:
In nanogram/milliliter (ng/ml) : Osteoprotegerin
Measured: at diagnosis and every month during 3 months
Measurement of cytokines:
- In microgram/liter (µg/l): Tryptase
Measured: at diagnosis and every month during 3 months
Inflammatory markers:
C reactive protein (milligramme/liter)
Measured: at diagnosis and every month during 3 months
Inflammatory markers:
In international Unit/ liter (IU/l) Rheumatoid factor,
Measured: at diagnosis and every month during 3 months
Inflammatory markers:
In international Unit/ liter (IU/l) Creatinine phosphokinase
Measured: at diagnosis and every month during 3 months
bone metabolism markers
In microgram/ liter : Cross-laps
Measured: at diagnosis and every month during 3 months.
bone metabolism markers
In microgram/ liter : Procollagen 1
Measured: at diagnosis and every month during 3 months.
bone metabolism markers
PTH (ParaTHormon) (nanogram/Liter)
Measured: at diagnosis and every month during 3 months.
bone metabolism markers
In millimole/Liter: Phosphates
Measured: at diagnosis and every month during 3 months.
bone metabolism markers
In millimole/Liter: Calcium.
Measured: at diagnosis and every month during 3 months.
Secondary outcomes (3)
Brief Pain Inventory (BPI) questionnaire
It will help to define the WS thanks to the calculation of the score of pain intensity. The score will be checked at the time the TKI is stopped (baseline) and then every month. Any increase of at least 2 points compared to the baseline will be significant enough to conclude to the TKI WS.
Pain intensity score is the mean of the scores of the four following questions in which the number 0 confers to "No pain" and 10 to "Pain as bad as the patient can imagine":
- Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last week.
- Please rate your pain by marking the box beside the number that best describes your pain at its least in the last week
- Please rate your pain by marking the box beside the number that best describes your pain on average
- Please rate your pain by marking the box beside the number that tells how much pain you have right now
Measured: 12 months
QDSA questionnaire
It derives from the McGill questionnaire and describes the type of pain rated by the patient: None = 0; Mild = 1 Moderate =2 Severe = 3. It will complete the BPI questionnaire by giving precision on the type of pain:
-Throbbing, Shooting, Stabbing, Sharp ...
Measured: 12 months
QLQ C-30 questionnaire
It will explore the quality of life every 3 months
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 posted24 Jun 2019
- Study start23 Apr 2019
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyacinthe JOHNSON-ANSAH, Dr, Principal investigator, UNIVERSITY HOSPITAL of CAEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996096
- Sponsor's protocol ID
- 18-206
- Acronym
- KIWIS
- Status last verified
- Mar 2023
- First submitted
- 23 May 2019
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not apllicable
Publications
Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.
PubMed 20965785Rousselot P, Charbonnier A, Cony-Makhoul P, Agape P, Nicolini FE, Varet B, Gardembas M, Etienne G, Rea D, Roy L, Escoffre-Barbe M, Guerci-Bresler A, Tulliez M, Prost S, Spentchian M, Cayuela JM, Reiffers J, Chomel JC, Turhan A, Guilhot J, Guilhot F, Mahon FX. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol. 2014 Feb 10;32(5):424-30. doi: 10.1200/JCO.2012.48.5797. Epub 2013 Dec 9.
PubMed 24323036Richter J, Soderlund S, Lubking A, Dreimane A, Lotfi K, Markevarn B, Sjalander A, Saussele S, Olsson-Stromberg U, Stenke L. Musculoskeletal pain in patients with chronic myeloid leukemia after discontinuation of imatinib: a tyrosine kinase inhibitor withdrawal syndrome? J Clin Oncol. 2014 Sep 1;32(25):2821-3. doi: 10.1200/JCO.2014.55.6910. Epub 2014 Jul 28. No abstract available.
PubMed 25071107Galimberti S, Fontanelli G, Barsotti S, Ricci F, Guerrini F, Barate C. Increased values of the circulating PDGFbeta sustains the "withdrawal syndrome" after tyrosine kinase inhibitor discontinuation in patients affected by chronic myeloid leukemia. Blood Cells Mol Dis. 2015 Oct;55(3):211-2. doi: 10.1016/j.bcmd.2015.06.010. Epub 2015 Jun 23. No abstract available.
PubMed 26227847
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Observationnelle Biologique Sur le Syndrome de Sevrage Des Inhibiteurs de Tyrosine Kinase Dans la Leucémie Myéloïde Chronique.
- ClinicalTrials.gov ID
- NCT03996096
- Acronym / sponsor ID
- KIWIS / 18-206
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 24 Jun 2019 (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.
Patients who suffer from chronic myeloid leukemia are treated by tyrosin kinase inhibitors (TKI) saying imatinib, nilotinib, dasatinib, bosutinib and ponatinib. These drugs are highly efficient with excellent response allowing some patients to definitely stop their cancer treatment. However, in 30% of cases, when the treatment is stopped, pains could arise in shoulders, hips, joints… These symptoms occurring after the withdrawal of a drug are odd and biologically unexplained so far. This study seeks to discover the biological factors behind these symptoms called 'TKI withdrawal syndrome' by the scientific community.
Detailed description
The success of TKI in the treatment of chronic myeloid leukemia is undeniable. Indeed, since the advent of imatinib in 2000 and the subsequent 4 other TKIs, this once fatal disease has become just another chronic disease with patient life expectancy close to the general population. Lifelong TKI therapy offers an 'operational cure' which means quiescent BCR-ABL leukemic stem cells are not eradicated but only controlled.
This statement was challenged in 2008 by the French 'STIM' study in which patients with undetectable BCR-ABL were proposed to discontinue their imatinib: 40% of these patients successfully achieved treatment free remission (TFR) with no recurrence of the disease. These figures are confirmed by the Australian 'TWISTER' study. The resumption of Imatinib therapy was triggered by the positivity of BCR-ABL. In the A-STIM study, the loss of major molecular response is the main criteria to resume imatinib. Accordingly, TFR was a success in 60% of patients. Similar figures was published with second generation TKIs with the same criteria.
In the light of these studies, it is clear that the fields have moved to a more ambitious goal than the operational cure, without the need for remaining on TKI.
Paradoxically, a new syndrome emerged from the Sweden group in 2014: 'the TKI withdrawal syndrome. It consisted of musculoskeletal pains resembling the Polymyalgia Rheumatica in CML patients after discontinuation of Imatinib. It occurred within 6 weeks in 30% of the patients who went on stopping imatinib. Patients with severe pain responded to 10-20 mg of prednisolone. Similar manifestations were described in the European 'EuroSki' study. No explanation was found.
It is well known that TKIs have off-target effects. In addition to BCR-ABL, they inhibit c-Kit, SRC, PDGFR, BTK, TEC, NFKB pathways resulting in anti-inflammatory effects. They can also cause disturbances in electrolyte balance (hypophosphatemia) and bone metabolism. Some research teams have correlated the success of TFR to the increase in cytotoxic NK cells and production IFN and TNFα.
Is the TKI withdrawal syndrome a rebound phenomenon from these off-target effects with excessive release of some cytokines? Of note, an Italian team showed in 4 out of 8 patients with WS an increase of PDGFβ (in 1 patient there was also increase in IL6, TGFβ and VEGF). But no tests were performed in the other patients who stopped TKI and did not presented with the WS as comparison.
Here, the proposed study concerns any CML patient candidate for TKI discontinuation. Will prospectively be checked a number of cytokines and biological factors susceptible to contribute to the clinical features taking into account the off-target effects of TKIs. Therefore, the investigators could compare the variation in a potentially involved cytokine within patients with or without withdrawal syndrome. In addition, the study will prospectively provide a broader description of TKI WS using Brief pain Inventory (BPI) questionnaire.
Eventually, cytokines, inflammatory and bone markers will be dosed at diagnosis and every month during 3 months corresponding to the timeframe in which the withdrawal syndrome is due to occur. A variation of 20% (increase or decrease) in whatever marker(s) will be considered significant if it is (or they are) observed in the group with "TKI withdrawal (TKI WS)" but not in the group without "TKI WS". Pathophysiological explanation of this syndrome could be assumed later taking into account the clinical presentation partly explored by the pain questionnaires
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with the TKI withdrawal syndrome | – | –There is no intervention. Patients will stop their tyrosine kinase inhibitor yielding to 2 subsets: patients with or without the TKI withdrawal syndrome. |
| Group without the TKI withdrawal syndrome | – | –As abovementioned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns patients suffering from Chronic myeloid leukemia treated with TKI (Imatinib, Nilotinib, dasatinib, bosutinib or Ponatinib) for at least 5 years with deep molecular response (MR4) for at least 2 years who agree to stop their drug. Other situation of TKI discontinuation. Five cities are participating in the study: CHU de Caen, CHU d'Amiens, CHU de Clermont-Ferrand, Centre Henri Becquerel de Rouen et le CH de Valenciennes.
Key inclusion criteria (3 listed)
- Adult CML patient candidate for TKI discontinuation.
- Performans status : 0-2
- Patient provided with information
Key exclusion criteria (3 listed)
- Patient unable to fulfill the questionnaires
- Patient suffering from demantia
- Patient treated with any cytokine antagonist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of cytokines:
Time frame: at diagnosis and every month during 3 months
Measurement of cytokines: A variation of 20% in a given marker will be significant if it is observed in the group with "TKI WS" but not in the group without "TKI WS". Of note, the patient will be his own witness. . In picogram/milliliter (pg/ml): IL2,IL 6, IL10, IL15, TGFβ,TNFα, IFNγ, VEGF, PDGFβ,
Measurement of cytokines:
Time frame: at diagnosis and every month during 3 months
In nanogram/milliliter (ng/ml) : Osteoprotegerin
Measurement of cytokines:
Time frame: at diagnosis and every month during 3 months
• In microgram/liter (µg/l): Tryptase
Inflammatory markers:
Time frame: at diagnosis and every month during 3 months
C reactive protein (milligramme/liter)
Inflammatory markers:
Time frame: at diagnosis and every month during 3 months
In international Unit/ liter (IU/l) Rheumatoid factor,
Inflammatory markers:
Time frame: at diagnosis and every month during 3 months
In international Unit/ liter (IU/l) Creatinine phosphokinase
bone metabolism markers
Time frame: at diagnosis and every month during 3 months.
In microgram/ liter : Cross-laps
bone metabolism markers
Time frame: at diagnosis and every month during 3 months.
In microgram/ liter : Procollagen 1
bone metabolism markers
Time frame: at diagnosis and every month during 3 months.
PTH (ParaTHormon) (nanogram/Liter)
bone metabolism markers
Time frame: at diagnosis and every month during 3 months.
In millimole/Liter: Phosphates
bone metabolism markers
Time frame: at diagnosis and every month during 3 months.
In millimole/Liter: Calcium.
3 secondary outcomes
Brief Pain Inventory (BPI) questionnaire
Time frame: 12 months
QDSA questionnaire
Time frame: 12 months
QLQ C-30 questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 20965785Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.
- Background: PubMed 24323036Rousselot P, Charbonnier A, Cony-Makhoul P, Agape P, Nicolini FE, Varet B, Gardembas M, Etienne G, Rea D, Roy L, Escoffre-Barbe M, Guerci-Bresler A, Tulliez M, Prost S, Spentchian M, Cayuela JM, Reiffers J, Chomel JC, Turhan A, Guilhot J, Guilhot F, Mahon FX. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol. 2014 Feb 10;32(5):424-30. doi: 10.1200/JCO.2012.48.5797. Epub 2013 Dec 9.
- Background: PubMed 25071107Richter J, Soderlund S, Lubking A, Dreimane A, Lotfi K, Markevarn B, Sjalander A, Saussele S, Olsson-Stromberg U, Stenke L. Musculoskeletal pain in patients with chronic myeloid leukemia after discontinuation of imatinib: a tyrosine kinase inhibitor withdrawal syndrome? J Clin Oncol. 2014 Sep 1;32(25):2821-3. doi: 10.1200/JCO.2014.55.6910. Epub 2014 Jul 28. No abstract available.
- Background: PubMed 26227847Galimberti S, Fontanelli G, Barsotti S, Ricci F, Guerrini F, Barate C. Increased values of the circulating PDGFbeta sustains the "withdrawal syndrome" after tyrosine kinase inhibitor discontinuation in patients affected by chronic myeloid leukemia. Blood Cells Mol Dis. 2015 Oct;55(3):211-2. doi: 10.1016/j.bcmd.2015.06.010. Epub 2015 Jun 23. No abstract available.
- Individual participant dataSharing planned: No. Not apllicable
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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.
Hyacinthe JOHNSON-ANSAH, Dr principal investigator
UNIVERSITY HOSPITAL of CAEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia and Tyrosine Kinase Inhibitor, run by University Hospital, Caen 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of cytokines: (time frame: at diagnosis and every month during 3 months). The study lists 11 primary outcomes in all. 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 NCT03996096, which also lists 4 linked publications.
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 14 Feb 2024.