Chronic Myeloid Leukemia Clinical Trial
— KIWISOfficial title:
Etude Observationnelle Biologique Sur le Syndrome de Sevrage Des Inhibiteurs de Tyrosine Kinase Dans la Leucémie Myéloïde Chronique.
NCT number | NCT03996096 |
Other study ID # | 18-206 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 23, 2019 |
Est. completion date | March 16, 2023 |
Verified date | March 2023 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 16, 2023 |
Est. primary completion date | March 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult CML patient candidate for TKI discontinuation. - Performans status : 0-2 - Patient provided with information Exclusion Criteria: - Patient unable to fulfill the questionnaires - Patient suffering from demantia - Patient treated with any cytokine antagonist |
Country | Name | City | State |
---|---|---|---|
France | University hospital | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Galimberti 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. — View Citation
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. — View Citation
Richter 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. — View Citation
Rousselot 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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, TGFß,TNFa, IFN?, VEGF, PDGFß, |
at diagnosis and every month during 3 months | |
Primary | Measurement of cytokines: | In nanogram/milliliter (ng/ml) : Osteoprotegerin | at diagnosis and every month during 3 months | |
Primary | Measurement of cytokines: | • In microgram/liter (µg/l): Tryptase | at diagnosis and every month during 3 months | |
Primary | Inflammatory markers: | C reactive protein (milligramme/liter) | at diagnosis and every month during 3 months | |
Primary | Inflammatory markers: | In international Unit/ liter (IU/l) Rheumatoid factor, | at diagnosis and every month during 3 months | |
Primary | Inflammatory markers: | In international Unit/ liter (IU/l) Creatinine phosphokinase | at diagnosis and every month during 3 months | |
Primary | bone metabolism markers | In microgram/ liter : Cross-laps | at diagnosis and every month during 3 months. | |
Primary | bone metabolism markers | In microgram/ liter : Procollagen 1 | at diagnosis and every month during 3 months. | |
Primary | bone metabolism markers | PTH (ParaTHormon) (nanogram/Liter) | at diagnosis and every month during 3 months. | |
Primary | bone metabolism markers | In millimole/Liter: Phosphates | at diagnosis and every month during 3 months. | |
Primary | bone metabolism markers | In millimole/Liter: Calcium. | at diagnosis and every month during 3 months. | |
Secondary | 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 |
12 months | |
Secondary | 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 ... |
12 months | |
Secondary | QLQ C-30 questionnaire | It will explore the quality of life every 3 months | 12 months |
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