KIWIS
Etude Observationnelle Biologique Sur le Syndrome de Sevrage Des Inhibiteurs de Tyrosine Kinase Dans la Leucémie Myéloïde Chronique.
Sponsor study identifier
observational
50
1 country
1
Study Start
April 23, 2019
Actual (reported)Primary Completion
March 16, 2023
Actual (reported)Study Completion
March 16, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 16, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2019
Actual (reported)May 23, 2019
Actual (reported)June 24, 2019
Actual (reported)March 16, 2023
Actual (reported)March 16, 2023
Actual (reported)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,
at diagnosis and every month during 3 months
Measurement of cytokines:
In nanogram/milliliter (ng/ml) : Osteoprotegerin
at diagnosis and every month during 3 months
Measurement of cytokines:
• In microgram/liter (µg/l): Tryptase
at diagnosis and every month during 3 months
Inflammatory markers:
C reactive protein (milligramme/liter)
at diagnosis and every month during 3 months
Inflammatory markers:
In international Unit/ liter (IU/l) Rheumatoid factor,
at diagnosis and every month during 3 months
Brief Pain Inventory (BPI) questionnaire
12 months
QDSA questionnaire
12 months
QLQ C-30 questionnaire
12 months
There is no intervention. Patients will stop their tyrosine kinase inhibitor yielding to 2 subsets: patients with or without the TKI withdrawal syndrome.
As abovementioned.
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.
University hospital
Caen, 14033, France
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.
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.
Plasma samples, if not used, will be kept frozen for further exploration if necessary. An amendment is produced and approved by ethics commitee in 2021/03/03. It relates to the KIR genes polymorphism and HLA class study in Caen patients in whom NK cell phenotype is available.
Hyacinthe JOHNSON-ANSAH, Dr
UNIVERSITY HOSPITAL of CAEN
50 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2019
First Posted
June 24, 2019
Study Start
April 23, 2019
Actual (reported)Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia
Inflammatory markers:
In international Unit/ liter (IU/l) Creatinine phosphokinase
at diagnosis and every month during 3 months
bone metabolism markers
In microgram/ liter : Cross-laps
at diagnosis and every month during 3 months.
bone metabolism markers
In microgram/ liter : Procollagen 1
at diagnosis and every month during 3 months.
bone metabolism markers
PTH (ParaTHormon) (nanogram/Liter)
at diagnosis and every month during 3 months.
bone metabolism markers
In millimole/Liter: Phosphates
at diagnosis and every month during 3 months.
bone metabolism markers
In millimole/Liter: Calcium.
at diagnosis and every month during 3 months.
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
March 16, 2023
Actual (reported)Study Completion
March 16, 2023
Actual (reported)Last Updated
February 14, 2024
Record last verified: 2023-03
Not apllicable
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