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The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.
Principal Objective : To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia .
Secondary Objective :
Study design : multicentric trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Imatinib treatment ending |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib ending | Behavioral | Interruption of the treatment by Imatinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts | Every month during the first year and every two months during the second year |
| Measure | Description | Time Frame |
|---|---|---|
| T lymphocytes differenciation and proliferation analyse / cytokines production analyse | first visit, M2,M4,M6,M9,M12,M18,M24 | |
| T lymphocytes apoptosis analyse | first visit | |
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Inclusion Criteria:
Exclusion Criteria:
Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe
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| Name | Affiliation | Role |
|---|---|---|
| François-Xavier MAHON, MD | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Angers | Angers | Angers | 49033 | France | ||
| Hôpital Morvan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41574312 | Derived | Mahon FX, Dulucq S, Rea D, Nicolini FE, Rigal-Huguet F, Machova Polakova K, Dubruille V, Noel MP, Ianotto JC, Villemagne B, Cayssials E, Park S, Rousselot P, Etienne G. Extended long-term follow-up and the survival of Stop Imatinib study. Blood Neoplasia. 2025 Oct 27;3(1):100177. doi: 10.1016/j.bneo.2025.100177. eCollection 2026 Feb. | |
| 28522576 |
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| Haemogramme analyse |
| every months during two years |
| Clinical exam | every three months during the first year and every four months during the second year |
| Brest |
| Brest |
| 29285 |
| France |
| Hôpital Henri-Mondor | Créteil | Créteil | 94000 | France |
| Hôpital Claude Huriez | Lille | Lille | 59037 | France |
| University Hospital Hôtel-Dieu | Nantes | Nantes | 44035 | France |
| Hôpital Saint Louis | Paris | Paris | 75475 | France |
| University Hospital Poitiers | Poitiers | Poitiers | 86021 | France |
| University Hospital Toulouse, Purpan | Toulouse | Toulouse | 31059 | France |
| University Hospital Brabois | Vandœuvre-lès-Nancy | Vandoeuvre Les Nancy | 54500 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| University Hospital Bordeaux, Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| Centre hospitalier-service de médecine interne Onco-Hématologique | La Roche-sur-Yon | 85025 | France |
| Hôpital André Mignot | Le Chesnay | 78157 | France |
| Hôpital Bicêtre, AP-HP | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Edouard Herriot | Lyon | 69374 | France |
| Institut Paoli Calmet | Marseille | 13273 | France |
| CHR de Metz-Thionville | Metz | 57038 | France |
| Centre Hospitalier de Nevers | Nevers | 58033 | France |
| University Hospital Nice | Nice | 06202 | France |
| Hôpital Necker-Enfants Malades | Paris | 75743 | France |
| Haut Lévêque Hospital | Pessac | 33604 | France |
| University Hospital Strasbourg, Hôpital Civil | Strasbourg | 67000 | France |
| Centre Hospitalier Bretagne Atlantique | Vannes | 56 017 | France |
| Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18. |
| 20965785 | Derived | 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. |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007938 | Leukemia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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