[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"French Innovative Leukemia Organisation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":272},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,69,92,115,143,164,186,208,228,250],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100593485","phase-2-phase-ii-study-evaluating-the-efficacy-and-safety-of-the-combination-of-tagraxofusp-and-venetoclax-in-treatment-naive-blastic-plasmacytoid-dendritic-cell-neoplasm-patients-100593485",false,"NCT07007052","Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients","Open Label Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients","TAGVEN","Inclusion Criteria:\n\n1. Patients with a confirmed BPDCN diagnosis according to WHO 2022 revised criteria and have not received previous treatment : patients with skin or lymph node lesions but no bone marrow involvement can be included\n2. Age \\>18 years\n3. Ability to understand the protocol and to sign an informed consent\n4. Possibility of follow-up\n5. ECOG \\\u003C 3\n6. Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault formula.\n7. Adequate cardiac function defined by LVEF \\>\u002F= 50% by MUGA or ECHO and no clinically significant abnormalities on a 12-lead ECG\n8. Albumin level≥3,2g\u002FdL\n9. Adequate liver function as demonstrated by:\n\n   * aspartate aminotransferase (AST) ≤ 2.5 × ULN\\*\n   * alanine aminotransferase (ALT) ≤ 2.5 × ULN\\*\n   * bilirubin ≤ 3.0 × ULN, unless due to Gilbert's syndrome\\* \\* Unless considered due to leukemic organ involvement, in that cases values must be ≤ 10 × ULN\n10. Men, and women of childbearing potential must be using a highly effective method of contraception\n11. Negative urine\u002Fblood pregnancy test within 1 week prior to the initiation of treatment (if applicable)\n12. Patient covered by any social security system\n\nExclusion Criteria:\n\n1. Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment.\n2. Previous treatment with venetoclax or tagraxofusp\n3. Treatment of BPDCN with any prior chemotherapy or investigational agents, except hydroxyurea for less than 14 days at the time of inclusion\n4. Concomitant immunosuppressive therapy -except for low-dose prednisone (≤10 mg\u002Fday)\n5. Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients.\n6. Pregnant or breastfeeding woman\n7. Known positivity for hepatitis B or C infection except for those subjects with an undetectable viral load or subjects with serologic evidence of prior vaccination to HBV\n8. Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal)\n9. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his\u002Fher participating in this study including, but not limited to:\n\n   * Cardiovascular disease e.g., NYHA heart failure \\> class 2, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrythmias not controlled by medication.\n   * Renal, pulmonary, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.\n10. Subject with a history of other malignancies within the last three years prior to study entry, except for:\n\n    * Adequately treated in situ carcinoma of the breast or cervix uteri\n    * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\n    * Prostate cancer without needs for specific therapy\n    * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n11. Malabsorption syndrome or other conditions that preclude enteral route of administration\n12. Patient with hereditary fructose intolerance","ALL","18 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to study the efficacy of the tagraxofusp + venetoclax combination in treatment-naive blastic plasmacytoid dendritic cell neoplasm adult patients.\n\nThe main question is to verify the response in patients after 3 cycles of tagraxofusp+venetolax and to demonstrate if the combination of tagraxofusp + venetoclax increases the rate of complete remission, assessed after 3 months of treatment.\n\nPatients will receive a ramp-up phase of venetoclax during 3 days and at least 3 cycles of venetoclax. After, the investigators will evaluate the response, and depending on the response observed, patients may receive additional cycles of treatment for a maximum of 24 cycles, or receive an allograft or discontinue the treatment in the case of therapeutic failure.",[27],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[29,30,31,32,33],"blastic plasmacytoid dendritic cell neoplasm","Combination of venetoclax + tagraxofusp","Composite complete remission","Complete remission","Evaluation of response","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2025-12-11",{"date":42,"type":21},"2031-10-02",{"name":44,"class":45},"French Innovative Leukemia Organisation","OTHER",34,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100530428","phase-2-evaluation-of-treatment-by-glofitamab-in-combination-with-rituximab-or-obinutuzumab-plus-chop-in-patients-with-richter-syndrome-100530428","NCT06186648","Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter Syndrome","A Phase 2 Study Evaluating the Bispecific CD3xCD20 Antibody GLOfitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) in Patients With RIchter Syndrome as Frontline therapY. A FILO Study","GLORIFY","Inclusion Criteria:\n\n1. Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to the revised iwCLL criteria with biopsy proven transformation to CD20 positive diffuse large B-cell lymphoma, consistent with RS according to the 2016 WHO classification\n2. A fresh or archival tissue biopsy is mandatory\n3. Previous therapy for CLL is allowed (but no prior therapy for RS)\n4. Age greater than or equal to 18 years and less or equal to 80 years\n5. ECOG performance status 0-2\n6. Participants must have at least one measurable target lesion (≥ 1.5 cm) in its largest dimension by computed tomography (CT) scan. Measurable disease, defined as at least one bi-dimensionally measurable nodal or tumor lesion, defined as \\> 1.5 cm in its longest dimension or PET-CT with at least one hypermetabolic lesion. Patients without measurable disease but with proven bone marrow infiltration by the RS are eligible.\n7. Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement of either CLL or RS cells confirmed on biopsy: absolute neutrophil count ≥ 1.5 G\u002FL, hemoglobin \\>10 g\u002FdL, and platelet count ≥75 G\u002FL independent of transfusion within 7 days of screening\n8. Subject must have adequate coagulation tests: Prothrombin Time \\> 50%, Fibrinogen \\> 1 g\u002FL\n9. Adequate liver function: Total bilirubin ≤ 1.5 x ULN; Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x ULN\n10. Adequate left ventricular ejection function (\\> 50 %)\n11. Adequate renal function: creatinine clearance calculated by MDRD\u002FCockcroft-Gault formula of ≥ 40 mL\u002Fmin\n12. Negative serologic or PCR test results for acute or chronic HBV infection\n13. Negative test results for HCV and HIV (Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation)\n14. Prior vaccination to the SARS-Cov-2 virus and and SARS-CoV-2 PCR testing and negative result before study treatment administration at each treatment cycle\n15. Negative serum or urinary pregnancy test within 7 days prior to study treatment in women of childbearing potential. Patients must agree to either remain completely abstinent or to use two effective contraceptive methods\\* until:\n\n    * If the patient is a male: at least 3 months after pre-treatment with obinutuzumab or RCHOP or 2 months after the last dose of glofitamab, whichever is longer. Men must refrain from donating sperm during this same period\n    * If patient is a female of childbearing potential: until at least 18 months after pre-treatment with obinutuzumab or RCHOP or 2 months after the last dose of glofitamab, whichever is longer\n16. Ability to understand and the willingness to sign a written informed consent document. Patient must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab. Patient must also be willing to comply with all study-related procedures\n17. Signed written informed consent\n18. Patient covered by any social security system\n\nExclusion Criteria:\n\n1. Patients with the Hodgkin variant of RS\n2. Patients with previously treated for RS\n3. Current or past history or presence of clinically relevant disorder affecting the central nervous system (CNS)\n4. Ineligible to CHOP full dose for any reason\n5. Previous treatment with a bispecific antibody\n6. Current or past history of DLBCL in the CNS (confirmed by CSF analysis)\n7. Steroids treatment (\\> 1 mg\u002Fkg\u002Fd for one week) before inclusion\n8. History of anaphylactic reactions to human, chimeric, or mouse monoclonal antibodies or to any components of the product.\n9. Prior allogeneic HSCT\n10. Patients with known acute infection or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, EBV, cytomegalovirus (CMV), hepatitis B, hepatitis C, HIV and SARS-CoV-2), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to the first study treatment.\n11. History of other malignancies, except: i) malignancy treated with curative intent and with no recurrence over the last 3 years ii) adequately treated non-melanoma skin cancer without evidence of disease iii) adequately treated carcinoma in situ without evidence of disease\n12. Prior solid organ transplantation\n13. History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:\n\n    * Grade ≥ 3 adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy\n    * Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation\n14. Current uncontrolled autoimmune disease\\*\n15. History of human immunodeficiency virus\n16. Hepatitis B or C seropositivity (unless clearly due to vaccination)\n17. Pregnant or breastfeeding women\n18. Unwilling or unable to participate in all required study evaluations and procedures.\n19. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form and authorization to use protected health information (in accordance with national and local subject privacy regulations)\n20. Persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care\n21. Fertile male patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study.\n22. Patients with history of macrophage activation syndrome (MAS) \u002F hemophagocytic lymphohistiocytosis (HLH)\n23. LVEF \\\u003C 50% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan, significant or extensive cardiovascular disease such as New York HeartAssociation Class III or IV cardiac disease or Objective Assessment Class C or D,myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina.\n24. Abnormal screening laboratory values as defined as following: a) ALT (SGOT) and\u002For ALT (SGPT) and\u002For ALP ≥ 3 x upper limit of normal (ULN); b) Total bilirubin ≥ 1.5 x ULN, unless due to Gilbert's disease; c) Creatinine ≥ 2.0 x ULN or creatinine clearance \\\u003C 40 mL\u002Fmin (calculated).\n25. Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)\n26. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n27. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug\n28. Major surgery or significant traumatic injury \\\u003C 28 days prior to the obinutuzumab infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment\n29. Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion\n30. Treatment with another investigational agent or participating in another trial within 30 days prior to entering the study\n31. Clinically significant history of liver disease or cirrhosis\n32. Pregnant or breast-feeding or intending to become pregnant during the study\n33. No affiliation to social security\n34. Inability to comply with protocol mandated hospitalization and restrictions.",{"count":56,"type":21},40,[24],"This is a national clinical trial, multicentric (28 centers), non-randomized phase 2 study.\n\nPopulation: Patients with previously untreated Richter's syndrome (RS), defined as the occurrence of an aggressive lymphoma (of diffuse large B-cell lymphoma histology) in a patient with chronic lymphocytic leukemia (CLL).\n\nStudy treatment:\n\nThe duration of each cycle is 21 days.\n\nCycle 1:\n\nParticipants will receive standard of care doses of R-CHOP in cycle 1 as follows:\n\n* Rituximab 375 mg\u002Fm² IV Day 1\n* Cyclophosphamide 750 mg\u002Fm² IV Day 1\n* Doxorubicin 50 mg\u002Fm² IV Day 1\n* Vincristine 1.4 mg\u002Fm² \\[capped at 2.0 mg\\] IV Day 1\n* Prednisone 60 mg\u002Fm2 per day PO Day 1-5\n\nCycle 2:\n\nIn order to minimize cytokine release syndrome (CRS), participants will then receive G-CHOP as cycle 2 (with obinutuzumab) and glofitamab:\n\n* Obinutuzumab 1000 mg single dose IV Day 1\n* Cyclophosphamide 750 mg\u002Fm² IV Day 1\n* Doxorubicin 50 mg\u002Fm² IV Day 1\n* Vincristine 1.4 mg\u002Fm² \\[capped at 2.0 mg\\] IV Day 1\n* Prednisone 60 mg\u002Fm2 per day PO Day 1-5\n* Glofitamab : administered intravenously (IV) as a step-up dose on Days 8 (2.5 mg) and 15 (10 mg)\n\nCycle 3-6:\n\nParticipants will receive standard of care doses of R-CHOP and Glofitamab as follows:\n\n* Rituximab 375 mg\u002Fm² IV Day 1\n* Cyclophosphamide 750 mg\u002Fm² IV Day 1\n* Doxorubicin 50 mg\u002Fm² IV Day 1\n* Vincristine 1.4 mg\u002Fm² \\[capped at 2.0 mg\\] IV Day 1\n* Prednisone 60 mg\u002Fm2 per day PO Day 1-5\n* Glofitamab : 30 mg IV Day 8\n\nCycle 7 and 8 (only for patient in Complete Response or Partial response after Cycle 6):\n\nCycle 7 and 8 consist of 2 infusions of glofitamab only at D8C7 and D8C8:\n\n● Glofitamab : 30 mg IV Day 8\n\nPrimary endpoint Percentage of participants with a complete response as assessed by the investigator using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3) after 6 cycles of R\u002FG-CHOP + glofitamab or at permanent treatment discontinuation.\n\nEnd of treatment is defined as after 6 cycles of R\u002FG-CHOP + glofitamab. Permanent treatment discontinuation is defined as the discontinuation of all treatments (R\u002FG-CHOP, glofitamab).",[60],"Richter Syndrome",{"date":62,"type":38},"2026-06-30",{"date":64,"type":38},"2024-03-21",{"date":66,"type":21},"2029-09-04",{"name":44,"class":45},23,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":79,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100394053","observatory-of-prolymphocytic-leukemia-t-100394053","NCT04411043","Observatory of Prolymphocytic Leukemia T","Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T. A FILO Study.","T-PLL","Inclusion Criteria:\n\n* Man or woman aged 18 or over\n* Patient with prolymphocytic T leukemia\n\nExclusion Criteria:\n\n* Absence of signature of informed consent",{"count":78,"type":21},50,"3 Years","OBSERVATIONAL","Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + \u002F CD8-, but also CD4 + \u002F CD8 + or CD8 + \u002F CD4-.\n\nThe main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.\n\nOn the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis.\n\nPatients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .\n\nMain objective: Better manage prolymphocytic T leukemias.\n\nSecondary objectives:\n\n* Molecular characterization of prolymphocytic leukemia T.\n* Study of the response to treatment, disease-free survival, overall survival.\n* Impact of prognostic factors on response to treatment, and survival.",[83,84],"Prolymphocytic Leukemia","T-cell Leukemia",{"date":37,"type":38},{"date":87,"type":38},"2020-07-01",{"date":89,"type":21},"2028-07-30",{"name":44,"class":45},1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100641030","phase-2-fixed-duration-treatment-with-combined-pirtobrutinib-and-short-course-immuno-chemotherapy-in-fit-patients-with-previously-untreated-symptomatic-chronic-lymphocytic-leukemia-cll-100641030","NCT07624799","Fixed Duration Treatment With Combined Pirtobrutinib and Short Course Immuno-chemotherapy in Fit Patients With Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL).","Fixed Duration Treatment With Combined Pirtobrutinib and Short Course Immuno-chemotherapy in Fit Patients With Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL). A Phase II FILO Trial","PACIFIC","Inclusion Criteria:\n\n* Immunophenotypically confirmed CLL according to IWCLL 2018 guidelines\n* Binet stage C or Binet stage A and B with active disease could be considered for inclusion according to IWCLL 20108 for initiation of treatment.\n* Absence of Del(17p) and TP53 mutation in NGS (cut off 1%)\n* ECOG performance status 0-2\n* CIRS (Cumulative Illness Rating Scale) ≤ 6\n* Adequate coagulation: defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN\n* Calculated creatinine clearance ≥ 30 ml\u002Fmin according to Cockcroft\u002FGault Formula: (140 - age) × body weight (kg) × 0.85 (if female) serum creatinine (mg\u002FdL) × 72\n* Adequate liver function:\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase or (ALT) ≤ 3 × the ULN or ≤ 5 × ULN with documented liver involvement,\n* Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement and\u002For Gilbert's Disease\"\n* Adequate hematology values:\n* absolute neutrophil count ≥ 0.75 x 109\u002FL,\n* platelet count ≥ 50 x 109\u002FL (accordance to the coordinator if linked to the disease),\n* Hemoglobin ≥ 80g\u002FL Notes: Hgb and platelets: independent of transfusions within 7 days of Screening assessment. ANC: independent of growth factor support within 7 days of Screening assessment. Criteria must be met on C1D1 without transfusion\u002FG-CSF within 7 days of assessment\n* Prior vaccination to the SARS-Cov-2 virus and SARS-CoV-2 PCR testing (if clinically indicated) and negative result before study treatment administration at each treatment cycle\n* The patient is able to take oral medications\n* Signed written informed consent\n* Willing or able to participate in all required study evaluations and procedures.\n* Ability to understand the purpose and risks of the study and to provide a signed and dated informed consent form and authorization to use protected health information (in accordance with national and local subject privacy regulations)\n\nExclusion Criteria:\n\n1. Presence of Clonal hematopoiesis of indetermined potential or CHIP (To define patients with CHIP: Presence of a myeloid mutation (whatever the mutation) with a VAF \\>2% in the granular fraction\n2. Binet stage A without active disease according to IWCLL 20108 criteria\n3. Life expectancy \\\u003C 6 months\n4. Current or past history or presence of clinically relevant disorder affecting the central nervous system (CNS)\n5. Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)\n6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   \\- Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal): Known history of human immunodeficiency virus, serologic status reflecting active hepatitis B virus or hepatitis C virus infection, any uncontrolled active systemic infection along with subjects who are ongoing anti-infective treatment and subjects who have received vaccination with a live attenuated vaccine within 4 weeks before the first dose of study treatment\n   1. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antibody (anti-HBs) negative will need to have a negative hepatitis B virus PCR result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B virus PCR positive will be excluded.\n   2. Subjects who are hepatitis C virus antibody positive will need to have a negative hepatitis C virus PCR result before enrollment. Those who are hepatitis C virus PCR positive will be excluded\n\n      * Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.\n      * Active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) (isolated positive DAT is not an exclusion criteria) and idiopathic thrombocytopenic purpura (ITP).\n7. Concomitant disease requiring prolonged use of corticosteroids (\\> 1 month)\n8. Patients treated by vitamin K antagonist or dual antiaggregant or anticoagulants (coumadin, warfarin)\n9. History of bleeding diathesis (e.g. hemophilia or von Willebrand disease)\n10. Prior solid organ transplantation\n11. Concurrent severe diseases that exclude the administration of therapy :\n\n    * Heart insufficiency NYHA grade III\u002FIV, LEVF LVEF \\\u003C 50% and or RF \\\u003C 30%, myocardial infarction within the past 6 months prior to study\n    * Significant cardiovascular disease such as symptomatic arrhythmias (including atrial fibrillation), congestive heart failure, unstable angina or acute coronary syndrome within the past 2 months prior to randomization or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional (Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study)\n    * Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33).\n\n      * Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n      * Correction for underlying bundle branch block (BBB) allowed\n    * Severe chronic obstructive lung disease with hypoxemia\n    * History of stroke or intra-cranial hemorrhage within the last 6 months\n    * Severe diabetes mellitus\n    * Uncontrolled hypertension\n    * Impaired renal function with creatinine clearance \\\u003C 30 ml\u002Fmin according the formula of Cockroft and Gault\n12. Patient who requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole (unless of separate dosing of pirtobrutinib capsules with antacids by at least 2 hours. Pirtobrutinib capsules should be taken 2 hours before an H2-receptor antagonist. Avoid co-administration of pirtobrutinib capsules with proton pump inhibitors).\n13. Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection)\n14. Evidence for Richter syndrome\n15. Treatment with any of the following within 7 days prior to the first dose of study drug: steroid therapy (see criteria 7 above) for anti-neoplastic intent.\n16. A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the investigator's opinion, would adversely affect the patient's participation in this study or interpretation of study outcomes.\n17. Major surgery within 30 days prior to the first dose of study treatment.\n18. History of prior other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following:\n\n    * Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study.\n    * Other cancers not specified above that have been curatively treated by surgery and\u002For radiation therapy from which patient is disease-free for ≥ 5 years without further treatment.\n19. Have a known hypersensitivity to any of the excipients of pirtobrutinib or to any intended study medications.\n20. Persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care\n21. Treatment with another investigational agent or participating in another trial within 30 days prior to entering the study\n22. No affiliate to social security\n23. Currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n24. Women of Childbearing Potential (WOCBP) unless the following criteria are met- a negative pregnancy test is required for all WOCBP within 21 days before start of study intervention, followed by immediate highly effective contraception; further pregnancy testing will be performed monthly.\n25. Fertile men or WOCBP unless the following criteria are met:\n\n    Willing to use 2 methods of reliable contraception, including one highly effective contraceptive method (Pearl Index \\\u003C 1) and one additional effective (barrier) method during study intervention and for 1 month after last pirtobrutinib dose (for WOCBP). Men must refrain from sperm donation during the study.\n26. Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study.\n27. Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.",{"count":101,"type":21},82,[24],"The evidence base in support of fixed-duration, first-line approaches in medically fit patients with CLL is clearly strengthening, whether through combining targeted agents with immunochemotherapy or through chemotherapy-free combinations. The long-term PB MRD response rates with the investagators fixed-duration (15-month) immunochemotherapy approach remain the best to date, even compared to the new targeted agent combinations of ibrutinib-venetoclax or obinutuzumab-venetoclax.\n\nThe investigators' phase 2 ICLL07 trial in previously untreated fit CLL patients with a fixed-duration immunochemotherapy approach (with 4 cycles of FC-obinutuzumab and chemosparing strategy) carries a low risk for short and long term toxicities which still exist, including cardiac toxicities probably related to BTK inhibitors, moreover, two patients experienced treatment related myelodysplastic syndrome or acute myeloid leukemia beyond the end of treatment. Follow-up at 5,5 years from treatment start showed a persistent PB MRD benefit beyond end of treatment, high survival rates, and low long term toxicity with no difference in the durability of MRD response between the mutated and unmutated IGHV patients.\n\nThe investigators aim to explore the safety and efficacy of a fixed duration strategy combining a new BTK inhibitor with a favorable safety profile and a limited number of ICT courses.\n\nThe main goals and concerns are:\n\ni) to ensure deep response and long lasting MRD ii) to reduce the duration of BTKi exposure and the risk of clonal evolution with the appearance of deleterious mutations iii) to limit the risk of hematopoietic secondary cancers (MDS\u002FAML) by excluding patients in whom clonal hematopoiesis of undetermined potential (CHIP) is detected before inclusion and decreasing the number of courses of chemotherapy to 3 cycles. Moreover, patients with TP53 abnormalities will be excluded with a lower cut off (1% versus 10% in the previous studies) iv) to limit the risk of BTKi toxicity by using a non-covalent BTKi",[105],"CLL (Chronic Lymphocytic Leukemia)","NOT_YET_RECRUITING","2026-05-29",{"date":109,"type":38},"2026-06-03",{"date":111,"type":21},"2026-09-01",{"date":113,"type":21},"2033-09-01",{"name":44,"class":45},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100628602","phase-2-study-evaluating-the-efficacy-and-safety-of-the-addition-of-ivosidenib-to-oral-azacitidine-onureg-in-patients-over-55-with-acute-myeloid-leukemia-aml-and-idh1-mutation-in-complete-remission-after-intensive-chemotherapy-100628602","NCT07463768","Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.","A Single Arm Phase II Study Investigating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy. A Study of the French AML Intergroup.","MIVONU","Inclusion Criteria:\n\n1. Male or female ≥ 55 years of age at the time of signing informed consent\n2. Patients with confirmation of newly diagnosed AML by 2022 WHO criteria\n3. Presence of IDH1 R132 mutation at AML diagnosis\n4. Achievement CR or CRi following induction therapy by intensive chemotherapy (according to ELN 2022, appendix 2), within 17 weeks prior to enrollment.\n5. Received at least 2 consolidations :\n\n   1. with intermediate dose of cytarabine (IDAC)\n   2. or with standard dose cytarabine and idarubicin (5+1)\n6. Adequate BM function: ANC ≥1 × 109\u002FL and platelet count ≥50 × 109\u002FL at the time of inclusion\n7. Patients who are not candidate for Allo-HSCT\n8. Adequate baseline organ function defined by the following criteria:\n\n   * Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml\u002Fmin (using CKD-EPI).\n   * aspartate aminotransferase (AST) ≤ 2.5 × ULN\n   * alanine aminotransferase (ALT) ≤ 2.5× ULN\n   * bilirubin ≤ 1.5 × ULN\n9. ECOG \\\u003C 3 (appendix 1)\n10. Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule\n11. Patient suitable for oral administration of study drug.\n12. A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP) as defined in post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented as surgically sterile (at least 1 month prior to Screening)\n    2. WOCBP agrees to follow the contraceptive treatment starting at screening and continued throughout the study period, and for at least 180 days after the final study drug administration.\n    3. WOCBP agrees to perform planned pregnancy tests in the study\n13. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for one month after the final study drug administration.\n14. Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.\n15. A male subject with a partner(s) of childbearing potential must agree to use contraception starting at screening and continue throughout the study period, for at least 90 days after the final study drug administration.\n16. A male subject must not donate sperm starting at screening nor throughout the study period and for 90 days after the final study drug administration\n17. Patient must be affiliated to the French social security (health insurance)\n18. Signed written informed consent for the study\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (FAB M3) with t(15;17) or its molecular equivalents (PML::RARA)\n2. AML associated with t(9;22) or molecular evidence of such a translocation\n3. Prior BM or hematopoietic stem cell transplantation\n4. CR\u002FCRi following treatment with hypomethylating agents\n5. Proven central nervous system leukemia\n6. Candidate for Allo-HSCT at screening\n7. Diagnosis of malignant disease within the previous 12 months (excluding MDS or CMML, basal cell carcinoma of the skin without complications, \"in- situ\" carcinoma of the cervix or breast, or other local malignancy excised or irradiated with a high probability of cure)\n8. Abnormal cardiac status with any of the following:\n\n   * Unstable angina\n   * Myocardial infarction within the last 6 months\n   * Significant cardiac arrhythmia\n   * New York Heart Association (NYHA) class 3 or 4 congestive heart failure\n   * Congenital long QT syndrome, familial history of sudden death or polymorphic ventricular arrhythmias and QT\u002FQTc interval \\> 500 msec regardless of the correction method.\n\n   For subject with 450 ≤ QTc ≤ 500 ms, practitioners should thoroughly reassess the benefit\u002Frisk of initiating ivosidenib. In case QTc interval prolongation is between 480 msec and 500 msec, initiation of treatment with ivosidenib should remain exceptional and be accompanied by close monitoring. This issue will be discussed with coordinating investigator.\n9. Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment)\n10. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study\n11. Severe medical or mental condition precluding the administration of protocol treatments\n12. Persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care\n13. Other comorbidity that the physician judges to be incompatible with the study design\n14. Any condition causing an inability to swallow tablets or known hypersensitivity to the study medication\n15. Any condition that would impair absorption of the study medication (i.e. short gut, malabsorption syndrome)\n16. Subject requiring treatment with concomitant drugs that are strong inducers\u002Finhibitors of cytochrome P450 (CYP)3A \u002FPGP or dabigatran (PGP substrate) (see appendix 6) or QT-prolongating agent other than 5-HT3 antagonists (see appendix 8) or other forbidden medications listed in section 10.7\n17. Subject with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption\n18. Subject with positive HIV test treated or planned to be treated with drugs with potential drug-drug interactions. HIV testing will be performed at screening, if required per local guidelines or institutional standards.\n19. Subject known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status with undetectable PCR viral load on antivirals (non-exclusionary medications) are not excluded.","55 Years",{"count":125,"type":21},60,[24],"After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population. We assume that the combination of ivosidenib with oral azacitidine will not be less well tolerated than in combination with the subcutaneous form, therapeutic regimen authorized until progression or toxicity. Ivosidenib and Onureg®, being already authorized treatments, it has been decided to use the classic administration schedules and dosages in combination.\n\nThe primary objective of the study is to evaluate relapse free survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib.",[129],"Acute Myeloid Leukemia",[131,132,133],"acute myeloid leukemia and IDH1 mutation","complete remission after intensive chemotherapy","ivosidenib and oral azacitidine","2026-03-10",{"date":136,"type":38},"2026-03-11",{"date":138,"type":21},"2026-09",{"date":140,"type":21},"2030-09",{"name":44,"class":45},20,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":80,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100545106","observatory-of-compassionate-use-of-ivosidenib-in-france-for-patients-with-acute-myeloid-leukemia-100545106","NCT06377579","OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patient with IDH1 R132 mutated with newly diagnosed or Relapsed or Refractory (R\u002FR) acute myeloid leukemia\n* Patient treated within French compassionate access program that have started the treatment between 01\u002F01\u002F2017 to 01\u002F08\u002F2023\n* patient treated by Ivosidenib received either as a monotherapy or in combination with other AML therapy (i.e. azacytidine, venetoclax)\n* Patient not included within IDH inhibitor clinical trial.\n\nExclusion Criteria:\n\n* Patients who expressed their opposition to entered in the study\n* Patients who received IVO through a trial",{"count":150,"type":21},250,"6 Months","Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)\u002FαKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis\n\nIvosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R\u002FR) AML and in front line settings. In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R\u002FR settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R\u002FR. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R\u002FR patients and March 2022 for first line treatment.\n\nIn this multicentric retrospective study, sponsor aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R\u002FR disease. Results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R\u002FR IDH1mut AML.",[154],"AML, Adult","2025-11-25",{"date":157,"type":38},"2025-11-26",{"date":159,"type":38},"2024-07-31",{"date":161,"type":21},"2026-06-01",{"name":44,"class":45},21,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100558188","phase-2-study-evaluating-the-efficacy-and-tolerance-of-a-zanubrutinib-and-bgb-11417-combination-in-patients-previously-treated-for-waldenstrm-macroglobulinemia-100558188","NCT06547866","Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia","Open Label Phase 2 Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia. A FILO Study","WAZABI","Inclusion Criteria:\n\n1. Be ≥ 18-year-old.\n2. Have received at least 1 prior line of treatment (excluding treatment with any BTKi or Bcl-2 antagonist, see non-inclusion criteria).\n3. Provide written informed consent.\n4. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.\n5. Have adequate renal function defined as creatinine clearance ≥ 50 mL\u002Fmin as determined by the Cockroft-Gault equation.\n6. Have adequate hepatic function defined as:\n\n   * total serum bilirubin ≤ 1.5 × ULN, unless bilirubin rise is due to Gilbert's syndrome or non-hepatic cause.\n   * alanine aminotransferase (ALAT) \\\u003C 2 × ULN\n   * aspartate aminotransferase (ASAT) \\\u003C 2 × ULN,\n7. Have adequate BM function defined as:\n\n   * absolute neutrophil count ≥ 1x109\u002FL\n   * platelet count ≥ 75 x109\u002FL\n8. For women of childbearing potential, a negative pregnancy test must be documented prior to enrollment.\n\n   * A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n   * A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.\n9. Agree to use a highly effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile). Patients using hormonal contraceptives (eg, birth control pills or devices) must use a barrier method of contraception (eg, condoms) as well.\n10. Ability to comply with study procedures, in the Investigator's opinion.\n11. Patient covered by any social security system\n\nExclusion Criteria:\n\n1. Have previously been treated with a BTK inhibitor.\n2. Have been previously treated with a bcl-2 antagonist.\n3. Have active central nervous system (CNS) disease as evidenced by cytology or pathology. In the absence of clinical signs of CNS disease, a lumbar puncture is not mandatory.\n4. Have significant or active cardiovascular disease:\n\n   * stage III to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure and\u002For with left ventricular ejection fraction \\\u003C 50%\n   * myocardial infarction within 6 months before study treatment.\n   * unstable angina within 6 months before study treatment.\n   * uncontrolled atrial arrhythmia.\n   * history of clinically significant ventricular arrhythmias (e.g sustained ventricular tachycardia, ventricular fibrillation, torsades de pointe).\n   * uncontrolled hypertension.\n   * history of stroke or intracranial hemorrhage within 180 days before the first dose of study drugs\n   * QTcF interval \\> 450 ms on screening electrocardiogram (ECG) evaluation.\n5. Have a history of stroke or intracranial hemorrhage within 6 months before first dose of study drug, have a history of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention:\n\n   * patients with constitutional hemophilia or von Willebrand's disease will be excluded.\n   * patients with acquired hemophilia will be excluded.\n   * Requires ongoing treatment with warfarin or warfarin derivatives.\n   * patients with acquired von Willebrand's disease related to WM can be included. i) if bleeding manifestations are considered as non-clinically significant (i.e.grade 2 or below) ii) or if bleeding manifestations have been corrected by plasma exchange\n6. Have received live vaccine within 4 weeks of inclusion.\n7. Receive other concomitant investigational therapy.\n8. Have a history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic condition that, in the opinion of the Investigator, would adversely affect a subject's participation in the study.\n9. Have currently active, clinically significant Child-Pugh Class B or C hepatic impairment.\n10. Present an inability or difficulty swallowing capsules\u002Ftablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function.\n11. Have a known allergy to either xanthine oxidase inhibitors or rasburicase or zanubrutinib (patients at risk for G6PD deficiency may be screened before enrolment).\n12. Are pregnant or lactating. Women of childbearing potential must agree to use highly effective contraception from the time of signing informed consent until end-of-treatment visit,\n\n    ≥90 days after last dose of BGB-11417-101 and Zanubrutinib. Male patients must be abstinent, vasectomized, or agree to the use of barrier contraception in combination with other methods.\n13. Have a history of other active malignancies requiring treatment within 3 years of study entry, with exception of (1) localized basal cell or squamous cell carcinoma of the skin, (2), adequately treated in situ endometrial carcinoma, (3) incidental histology finding of prostate carcinoma, (4) previous malignancy confined and treated locally (surgery or other modality) with curative intent.\n14. Be known to be positive for HIV.\n15. Present evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    * uncontrolled and\u002For active systemic infection (viral, bacterial or fungal) including COVID-19\n    * chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \\[c\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Patients with serologic evidence of prior resolved infection can be included according to recommendations .\n16. Suffer from any condition or illness that, in the opinion of the Investigator or medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the study drugs.\n17. Have received or consumed any of the following within 3 days prior to the first dose of study drugs:\n\n    * grapefruit or grapefruit products.\n    * Seville oranges (including marmalade containing Seville oranges).\n    * star fruit.\n18. Have received a treatment with any of the following prior to the first dose of study drugs:\n\n    * ≤7 days steroid therapy with anti-neoplastic intent.\n    * ≤ 7 days or 5 half-lives (whichever is longer) of any moderate or strong CYP3A4 inhibitor and ≤ 14 days or 5 half-lives, (whichever is longer) of moderate or strong CYP3A4 inducer before the first dose of study drugs.\n    * allogeneic or autologous stem cell transplantation or CAR-T cell therapy less than 3 months before the first dose of study drugs.\n19. Severe or debilitating pulmonary disease.\n20. Major surgery within 4 weeks of the first dose of study drug.\n21. Active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).\n22. Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.",{"count":173,"type":21},102,[24],"This is a French multicenter open label non-randomized Phase II trial evaluating the efficacy and tolerance of a combination of oral zanubrutinib and BGB-11417 in subjects aged 18 years and older with previously treated Waldenström macroglobulinemia (WM) who require therapy according to the consensus panel criteria from the Second International Workshop on Waldenström's macroglobulinemia.\n\npopulation : Patients with previously treated Waldenstrom macroglobulinemia\n\nThe investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.Treatment will be administered for a total of twenty 28 day cycles:\n\n* Cycle 1 with zanubrutinib only\n* Cycle 2 with zanubrutinib plus BGB-11417 ramp-up\n\n  * cycle 2, day 1 : 10mg\n  * cycle 2, day 2 : 20 mg\n  * cycle 2, day 3 : 40mg\n  * cycle 2, day 4-7 : 80md daily\n  * cycle 2, day 8 and beyond : 160 mg daily\n* Cycles 3-20 with zanubrutinib plus BGB-11417 full dose",[177],"Waldenstrom Macroglobulinemia","2025-11-21",{"date":157,"type":38},{"date":181,"type":21},"2025-12-01",{"date":183,"type":21},"2031-12-31",{"name":44,"class":45},37,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":196,"studyType":80,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100509313","prognostic-analyses-on-a-validation-series-of-patients-with-waldenstrms-disease-100509313","NCT05911802","Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease","Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease: Validation of International Prognostic Indexes, Evaluation of Progression-free Survival as a Surrogate Endpoint for Overall Survival. A FILO Study.","SérieProWM","Inclusion Criteria:\n\n* Patient with WM, fulfilling the diagnostic criteria defined at the 2nd Workshop on WM.\n* Patient in whom follow-up is available until at least 01\u002F01\u002F2020. Each participating center should not enroll more 10% of patients lost to follow-up.\n* Patient for whom a minimum annual follow-up is planned until 2024.\n* Having given their consent for this study\n\nExclusion Criteria:\n\n* Patient with other chronic lymphoid malignancy. Special attention will be paid to exclude other lymphoplasmacytic proliferations, especially marginal zone lymphoma.\n* Patient with histological transformation in a diffuse large B-cell lymphoma or any other lymphoma at the time of the initiation of the 1st treatment.\n* No consent for this study.",{"count":195,"type":21},500,"5 Years","Waldenström's macroglobulinemia (WM) is defined by the association of bone marrow lymphoplasmocytic infiltration and monoclonal immunoglobulin M (IgM). A mutation in the MYD88 gene is found in up to 90% of patients, and a mutation in the CXCR4 gene in approximately one third of patients. Treatment should be initiated in cases of cytopenia, bulky disease or when the physicochemical or immunological properties of IgM explain the occurrence of amyloidosis, cryoglobulin, neurological manifestations, or hyperviscosity syndrome (due to the presence of a large amount of IgM). However, approximately 30% of patients are diagnosed without any symptom and therefore they do not meet the criteria for initiating treatment.\n\nAt the time of initiation of the first treatment, the prognosis is usually estimated with the International Prognostic Index (IPSSWM) which is based on five variables: age, platelet count, haemoglobin concentrations, β2-microglobulin and monoclonal component concentration. Serum albumin and lactate dehydrogénase (LDH) levels also retain a prognostic role and these two characteristics have been incorporated in a proposal for a revision of this index.\n\nImproving prognostic assessment at the time of the first treatment initiation and taking into account the prognostic impact of events occurring in the course of evolution, should improve the strength of treatment decision at the time of initial treatment and during the follow-up. It should also help to design clinical trial for fast and effective evaluation of new treatments. Our work should also help to adjust clinical monitoring of asymptomatic patients.\n\nProspective and retrospective multicenter prognostic study with a descriptive objective, associated with a biological collection appropriately annotated and stored. A retrospective series including 470 patients with symptomatic WM is already available. The follow-up of these patients will be updated and an additional series of 250 symptomatic patients will be prospectively enrolled. 250 asymptomatic patients will be also enrolled.",[199,200],"Waldenstrom's Disease","Prognostic Index",{"date":157,"type":38},{"date":203,"type":38},"2023-08-11",{"date":205,"type":21},"2030-06-15",{"name":44,"class":45},15,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":214,"maxAge":4,"enrollmentInfo":215,"targetDuration":196,"studyType":80,"phases":4,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100584576","epidemiological-study-of-a-prospective-cohort-of-patients-aged-60-and-over-managed-for-acute-myeloid-leukemia-aml-and-receiving-intensive-induction-therapy-100584576","NCT06891144","Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy","Inclusion Criteria:\n\n* Patients aged 60 and over\n* Patients with previously untreated de novo or secondary AML\n* Patients suitable for standard intensive treatment\n* Patients who have read the information document and agreed to the collection of data concerning them (signature of informed consent).\n\nExclusion Criteria:\n\n* Patients with AML 3\n* Patients with severe, uncontrolled infection at the time of inclusion\n* Patients with psychiatric or social disorders that will prevent compliance with the protocol\n* Patients without health insurance (affiliation to a social security scheme)","60 Years",{"count":216,"type":21},1000,"This observational epidemiological study targets patients aged 60 and over with de novo or secondary acute myeloblastic leukemia suitable for intensive receive intensive induction therapy as defined by the group. The main aim of the study is to determine the epidemiological characteristics of AML patients, both clinically and biologically, and to correlate these to their outcome. The incidence of AML increases with age, exponentially after the age of 50, giving a median age at diagnosis of close to 70 years, with over half of patients half of patients are over 60 at diagnosis. The principle of treatment as in younger patients, is based on trying to achieve complete remission (CR). remission (CR). Observed complete remission rates range from 38 to 70%. Long-term survival of elderly subjects remains limited, at around 10 to 15%, despite the various types of consolidation tried out in recent years.\n\nyears. However, intensive chemotherapy remains the preferred option for initial treatment of these hematological diseases when general condition and comorbidities allow. As shown by Swedish registry studies, it is associated with improved life expectancy.\n\nThe proportion of patients who can receive intensive initial treatment is not well known in France, probably varies widely from one region to another, and certainly decreases with increasing age. Only the registry studies currently underway will enable us to assess this precisely.",[154],"2025-03-20",{"date":221,"type":38},"2025-03-24",{"date":223,"type":38},"2015-01-06",{"date":225,"type":21},"2031-01-06",{"name":44,"class":45},27,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":142},"100517781","phase-2-study-investigating-the-efficacy-and-safety-of-the-addition-of-oral-azacitidine-to-salvage-treatment-by-gilteritinib-in-subjects-18-years-of-age-with-relapsedrefractory-flt3-mutated-acute-myeloid-leukemia-100517781","NCT06022003","Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed\u002FRefractory FLT3-mutated Acute Myeloid Leukemia","Open-label, Phase 2 Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed\u002FRefractory FLT3-mutated Acute Myeloid Leukemia","OGILAR","Inclusion Criteria:\n\n1. Confirmed diagnosis of acute myeloid leukemia (AML) according to world health organization (WHO) 2016 classification\n2. Presence of FLT3-mutation(s) at inclusion: in case of FLT3-ITD, the ITD\u002Fwt ratio must be \\> 0.05 ; in case of FLT3-TKD, the mutation must be at D835 or I836 position with a VAF \\> 5% by NGS.\n3. Subjects must be primary refractory or relapsed (R\u002FR) to 1st line intensive chemotherapy (ICT) for AML. Hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis.\n\n3a. Primary refractory is defined as no CR or CRi after at least one course of ICT (including \"7+3\", gemtuzumab ozogamycin (GO)-based and CPX-351, including or not midostaurine) or two courses (maximum 4) of AZA and venetoclax 3b. Relapse after 1st line ICT for AML is defined as the first hematologic relapse with bone marrow blasts \\>5% after one line of treatment for AML that includes at least one course of ICT (one line of treatment for AML can include induction, re-induction, consolidation, allogeneic HSCT and maintenance) 3c. Relapse after 1st line non intensive chemotherapy for AML is defined as the first hematologic relapse with bone marrow blasts \\>5% after or during treatment by AZA venetoclax regardless of number of cycles 4. 1st line intensive treatment may or may not include previous treatment by tyrosine kinase inhibitor (TKI) except gilteritinib.\n\n5\\. Patients who never received oral azacitidine 6. Age ≥ 18 years 7. Adequate baseline organ function defined by the criteria below:\n\n* adequate renal function as demonstrated by a creatinine clearance ≥ 50 ml\u002Fmin; calculated by the Cockcroft gault formula or measured by 24-hours urine collection\n* aspartate aminotransferase (AST) ≤ 2.5 × ULN\n* alanine aminotransferase (ALT) ≤ 2.5× ULN\n* bilirubin ≤ 1.5 × ULN\n* adequate cardiac function with LVEF ≥45% 8. ECOG \\\u003C 3 (appendix 1) 9. Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule 10. Patient is suitable for oral administration of study drug. 11. A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies: 9a. Not a woman of childbearing potential (WOCBP) as defined in post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented as surgically sterile (at least 1 month prior to Screening) 9b. WOCBP agrees to follow the contraceptive treatment starting at screening and continue throughout the study period, and for at least 180 days after the final study drug administration 12. Patient must be affiliated to the french social security (health insurance) 13. Signed written informed consent for the study 14. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.\n\n  15\\. Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.\n\n  16\\. A male subject with female partner(s) of childbearing potential must agree to use contraception starting at screening and continue throughout the study period, for at least 120 days after the final study drug administration.\n\n  17\\. Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.\n\nExclusion criteria\n\n1\\. Subjects with any of the following current or previous diagnoses:\n\n1a. AML secondary to prior myeloproliferative syndrome (MPN)\n\n1b. Acute promyelocytic leukemia (APL) and core binding factor (CBF) AML\n\n1c. DNA fragility or bone marrow (BM) failure syndromes\n\n1d. Blastic plasmacytoid dendritic cell neoplasm\n\n1e. Acute lymphoblastic leukemia including ambiguous lineage 2. Patients ≥ 3rd line of treatment, HSCT being not considered as a line of treatment 3. Patients previously treated by AZA as single agent for AML are not allowed 4. Subjects that have previously been treated by gilteritinib 5. Subjects that have previously been treated by oral azacitidine 6. Clinically active central nervous system (CNS) leukemia 7. Subjects who have received more than 1 prior allogeneic HSCT 8. Subjects who have relapsed within 100 days after allogeneic HSCT 9. Presence of Grade 2 or above graft-versus-host disease (GVHD), including acute, chronic, or overlap; or escalation of therapy for GVHD within 14 days prior to randomization 10. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A (Annexe 7) 11. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the subject (Annexe 7) 12. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis or hyperbilirubinemia) 13. Participant has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation (DIC).\n\n14\\. Subject exhibiting evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal).\n\n15\\. Isolated extramedullary leukemia relapse 16. History of another malignancy within the past 3 years except basal cell carcinoma of the skin or cervix in situ carcinoma 17. Any other serious medical condition, laboratory abnormalities or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent 18. Severe medical or mental condition precluding the administration of protocol treatments 19. persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care 20. Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrolment 21. Subject with Positive HIV test (due to potential drug-drug interactions). HIV testing will be performed at screening, if required per local guidelines or institutional standards. Subject known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status with undetectable PCR viral load on antivirals (non-exclusionary medications) are not excluded 22. Known hypersensitivity to the study medication 23. Subject has congestive heart failure classified as New York Heart Association Class III and IV unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45% 24. Subject with mean Fridericia-corrected QT interval (QTcF) \\> 450 ms at screening based on central reading 25. Subject with a history of Long QT Syndrome at screening",{"count":20,"type":21},[24],"Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group.\n\nUntil now, there was no established standard for relapsed subjects with FLT3 mutations and less than 20% will achieve CR with subsequent treatment.\n\nIn phase 3 Study ADMIRAL Trial, gilteritinib has resulted in CRc in over 25% of subjects receiving 120 mg\u002Fday before on study HSCT. With this treatment, the median overall survival is at 9.3 months, furthermore, gilteritinib was well tolerated at the proposed doses. This study has been designed for R\u002FR patients for which gilteritinib as single agent has been showed to be superior to high- and low-intensity chemotherapy (Perl, NEJM 2019, Supp Table S4) and patients included in this study will receive this treatment. Beyond high- or low-intensity chemotherapy, other options available are best supportive car or other clinical trials.\n\nThe aim of this study is to assess the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed\u002Frefractory FLT3-mutated acute myeloid leukemia",[154,240,241,242,243],"Refractory AML","Relapsed Adult AML","FLT3-TKD Mutation","FLT3-ITD",{"date":221,"type":38},{"date":246,"type":38},"2024-01-13",{"date":248,"type":21},"2027-10",{"name":44,"class":45},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":260,"studyType":80,"phases":4,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100536327","results-from-a-french-temporary-utilization-authorization-of-first-line-acute-myeloid-leukemia-aml-patients-ineligible-for-intensive-chemotherapy-ic-treated-with-venetoclax-azacitidine-100536327","NCT06263387","Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine","Results From a Nationwide Cohort Temporary Utilization Authorization (ATU) of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC),Treated in France With Venetoclax Azacitidine","VENAZA","Inclusion Criteria:\n\n* Adult patients\n* treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy\n* Treatment in the named-patients program (ATU)\n\nExclusion Criteria:\n\n* Treatment with VEN-AZA for previously treated AML\n\n  * Prior treatment for preexisting hematological malignancies other that AML, including AZA is not an exclusion criteria\n  * HYDROXYCARBAMIDE given for AML is not an exclusion criteria\n  * AZA started before VEN for AML is not an exclusion criteria\n* Opposition to data collection",{"count":259,"type":21},230,"18 Months","Following the results of the phase 1b and the phase 3 studies, Venetoclax\u002FAzacitidine (VEN\u002FAZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.\n\nVenetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN\u002FAZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit\u002Frisk profile of treatment. Early access to treatment in France is close to real-life setting condition.",[154],"2024-07-22",{"date":265,"type":38},"2024-07-23",{"date":267,"type":38},"2024-07-04",{"date":269,"type":21},"2025-03-30",{"name":44,"class":45},42,""]