[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stichting Hemato-Oncologie voor Volwassenen Nederland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":261},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,79,101,126,150,174,196,217,238],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100610148","phase-3-bleximenib-in-combination-with-standard-induction-and-consolidation-therapy-followed-by-maintenance-for-treatment-of-patients-with-acute-myeloid-leukemia-aml-100610148",false,"NCT07223814","Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)","Bleximenib or Placebo in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for the Treatment of Patients With Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a Double-blind Phase 3 Study","Inclusion Criteria:\n\n1. ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.\n2. New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.\n3. Considered eligible for intensive chemotherapy.\n4. WHO\u002FECOG performance status ≤2.\n5. Adequate renal and hepatic functions prior to randomization.\n\nExclusion Criteria:\n\n1. Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents\n2. Known active leukemic involvement of the central nervous system (CNS).\n3. Recipient of solid organ transplant.\n4. Cardiac disease:\n\n   1. Any of the following within 6 months of randomization: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (NYHA Class III or IV), uncontrolled or symptomatic arrhythmias, stroke, or transient ischemic attack.\n   2. QTc interval using Fridericia's formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted.\n   3. Left ventricular ejection fraction (LVEF) \\\u003C40% by ECHO or MUGA scan obtained within 28 days prior to the start of study treatment.\n   4. Previously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg\u002Fm2.\n5. Chronic respiratory disease requiring supplemental oxygen.","ALL","18 Years",{"count":19,"type":20},875,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation.\n\nBleximenib blocks the interaction between a protein called menin and another protein called KMT2A in the leukemia cells. When this interaction is disrupted in AML with mutations in the NPM1 or KMT2A gene, bleximenib can cause leukemia cells to die.\n\nThe main objective is to assess if treatment with bleximenib, when added to chemotherapy treatment will improve treatment outcome in adult participants with newly diagnosed AML who present with mutations in the NPM1 or KMT2A genes.\n\nThis is a randomized, double-blind, placebo-controlled, phase 3 clinical trial. All of the participants will receive standard chemotherapy treatment, combined with either bleximenib or a placebo. A placebo is a substance that looks like the study medicine but has no active ingredients (e.g., a sugar pill). In a double blind trial neither the participant nor the doctor know if placebo or active study drug is given.\n\nAfter the end of the protocol treatment there will be an observational follow-up of 4 years from the time of inclusion of the last patient. The results of the different treatment groups will be compared.\n\n875 previously untreated patients with AML with a specific change in the DNA of the leukemia cells (a KMT2A rearrangement or a NPM1 mutation) will be included. Participants must be 18 years or older and considered eligible for intensive chemotherapy.",[26],"Acute Myeloid Leukemia",[28,29,30,31,32],"AML","adult","newly diagnosed AML","NPM1","KMT2A","RECRUITING","2026-03-31",{"date":36,"type":37},"2026-04-06","ACTUAL",{"date":39,"type":37},"2026-03-01",{"date":41,"type":20},"2033-12",{"name":43,"class":44},"Stichting Hemato-Oncologie voor Volwassenen Nederland","OTHER",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100532993","phase-3-prevention-of-anthracycline-induced-cardiac-dysfunction-with-dexrazoxane-in-patients-with-diffuse-large-b-cell-lymphoma-100532993","NCT06220032","Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma","ANTICIPATE: Prevention of ANThracycline-Induced Cardiac Dysfunction by Dexrazoxane In PATients With diffusE Large B-cell Lymphoma: a Phase III National Multicenter Prospective Randomized Open-label Trial","HO170DLBCL","Inclusion Criteria:\n\n1. Untreated patients with a confirmed histologic diagnosis of CD20+ DLBCL according to WHO classification 2022:\n\n   * DLBCL, not otherwise specified (NOS)\n   * High-grade B-cell lymphoma NOS\n   * High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 translocation when DA-EPOCH-R is not an option. R2- CHOP is allowed.\n   * Follicular lymphoma\n   * T-cell\u002Fhistiocyte-rich B cell lymphoma (THRBCL)\n\n   Note: Transformed, previously untreated lymphoma is allowed.\n\n   Note: 5-day treatment of dexamethasone 15 mg\u002Fday or prednisone 100 mg\u002Fday or local radiotherapy in order to control life-threatening\u002Finvalidating tumor related symptoms is allowed.\n\n   Note: It is allowed to start with a first cycle of R-CHOP21 pending the FISH results.\n2. Planned treatment with 6 R-CHOP21. The following regimens are also allowed:\n\n   * Treatment with reversed R-CHOP21\n   * Treatment with R2-CHOP21 (6 R-CHOP21 + lenalidomide 15 mg day 1-14) in case of double hit lymphoma\n   * Two additional administrations of rituximab after 6 cycles of R-CHOP21\n   * High dosis MTX and\u002For MTX-it for CNS prophylaxis\n3. Ann Abor stages II-IV and stage I if the treatment plan is 6 R-CHOP21 in case of bulky disease (defined as a ≥10 cm mass);\n4. Age ≥ 18 years;\n5. WHO performance status ≤ 2, WHO 3 performance status is allowed when considered directly related to the DLBCL;\n6. Negative pregnancy test at study entry for women of childbearing potential;\n7. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice two effective methods of contraception, at the same time, from the time of signing the informed consent through at least 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse;\n8. Male patient, even if surgically sterilized, (i.e., status post vasectomy) agrees to practice effective barrier contraception during the entire study period and through 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse;\n9. Patient is able to adhere to the study visit schedule and other protocol requirements;\n10. Written informed consent.\n\nExclusion Criteria:\n\n1. Any of the following B-cell lymphomas according to WHO classification 2022:\n\n   o Central Nervous System involvement by DLBCL;\n\n   Note: high CNS-IPI is allowed\n   * Testicular DLBCL;\n   * Primary mediastinal B-cell lymphoma;\n   * Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder;\n2. Any prior malignancy or present malignancy other than DLBCL that required or requires systemic therapy. Prior surgery or local radiotherapy is allowed in case the heart has not been exposed.\n3. Patients requiring treatment with mini-R-CHOP\n4. Pre-existing cardiac disease including:\n\n   * LVEF \\\u003C50% measured with echocardiography (2D or 3D)\n   * Symptomatic heart failure (NYHA ≥II) or hospitalization for heart failure in the last year;\n   * Refractory anginal symptoms\n   * Cardiac arrhythmias not controlled with optimal medical treatment, in case of atrial fibrillation the ventricular response needs to be \\\u003C110\u002Fmin;\n   * Significant valvular dysfunction on echocardiography;\n   * Non-ischemic cardiomyopathy\n5. Non-diagnostic\u002Fpoor transthoracic echocardiography imaging quality at baseline;\n6. Severe pulmonary dysfunction defined as breathlessness at rest (COPD GOLD III or IV), unless clearly related to DLBCL;\n7. Severe neurological or psychiatric disease;\n8. Inadequate hematological function (absolute Neutrophil Count (ANC) \\\u003C1.0x109\u002FL or platelets \\\u003C75x109\u002FL), unless clearly related to DLBCL;\n9. Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times the upper limit of normal) unless related to lymphoma infiltration of the liver;\n10. Active hepatitis B or C infection (serology testing is required at screening). Patients positive for hepatitis B surface antigen (HBsAg) regardless of antibody status or HBsAg negative but anti-HBc positive are only eligible if HBV-PCR is negative and patients are protected with lamuvidine or entecavir. Patients with positive hepatitis C serology are only eligible if HCV-(RNA) is confirmed negative;\n11. Significant renal dysfunction (creatinine clearance \\\u003C 30 ml\u002Fmin after rehydration) or requiring dialysis;\n12. Active uncontrolled fungal, bacterial and\u002For viral infection;\n13. Patient known to be HIV-positive;\n14. Breast-feeding female patients;\n15. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;\n16. Participation in another clinical trial with anti-cancer therapy or a cardiovascular drug.",{"count":55,"type":20},324,[23],"Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity. Thereby patients treated for this malignancy are at double the risk of developing symptomatic heart failure \u002F cardiomyopathy when compared to the general population. This corresponds to a cumulative incidence of 5-10% within 5-years after receiving R-CHOP. In the elderly, an incidence of 26% has been reported after 8-years of follow-up. Among patients who die in complete remission, heart failure has been described to be one of the most important causes of death. ANTICIPATE aims to evaluate if dexrazoxane can prevent AICD in DLBCL patients and identify those at highest risk of AICD. Of all patients treated with anthracyclines in a first-line setting, DLBCL patients were chosen for this trial for two primary reasons. Firstly, these patients have a favourable oncological prognosis with a 5-year relative survival in the Netherlands of 64-78% in those aged 18-74 years increasing the importance of preventing long-term toxicity. Secondly, the cumulative anthracycline dose used for the treatment of DLBCL is higher than the dose used in breast cancer. The cumulative anthracycline dose is the most important risk factor for AICD known.",[59],"DLBCL - Diffuse Large B Cell Lymphoma",[61,62,63,64,65,66,67,68,69],"dexrazoxane","primary prevention","cardiotoxicity","heart failure","diffuse large B-cell lymphoma","R-CHOP","FL","R2CHOP","LVEF","2026-01-02",{"date":72,"type":37},"2026-01-05",{"date":74,"type":37},"2024-08-15",{"date":76,"type":20},"2028-12-15",{"name":43,"class":44},25,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100402681","phase-2-retreatment-with-venetoclax-and-acalabrutinib-after-venetoclax-limited-duration-reveal-100402681","NCT04523428","REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)","A Prospective, Multicenter, Phase-II Trial of Venetoclax Plus Acalabrutinib in Patients Who Have Relapsed After First Line Venetoclax + Anti-CD20 mAb Treatment for Chronic Lymphocytic Leukemia (CLL or SLL)","Inclusion Criteria:\n\n* Documented CLL or SLL requiring treatment according to IWCLL criteria (appendix A) after at least (clinical) partial response as best response after the following initial study treatment: venetoclax-rituximab in HOVON 140\u002FGAIA or venetoclax-obinutuzumab in HOVON 139\u002FGIVE or HOVON 140\u002FGAIA;\n* WHO\u002FECOG performance status 0-3 (appendix C), stage 3 only if attributable to CLL\n* Age at least 18 years;\n* Adequate BM function defined as:\n\n  * Hemoglobin \\>5 mmol\u002Fl or Hb \\> 8 g\u002FdL\n  * Absolute neutrophil count (ANC) \\>0.75 x 109\u002FL (750\u002FμL), unless directly attributable to CLL infiltration of the BM, proven by BM biopsy\n  * Platelet count \\>30 x 109\u002FL (30,000\u002FμL) without transfusion and irrespective whether it is attributable to CLL infiltration in the BM;\n* Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl ≥ 30ml\u002Fmin (Cockcroft-Gault appendix E); Please note: in case eGFR or CrCl is \\\u003C50ml\u002Fmin the patient needs to be considered high risk for TLS\n* Adequate liver function as indicated:\n\n  * Serum aspartate transaminase (ASAT) and alanine transaminase (ALAT) ≤ 3.0 x upper limit of normal (ULN);\n  * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin);\n* Prothrombin time (PT)\u002FInternational normal ratio (INR) \\\u003C1.5 x ULN and activated partial thromboplastin time (aPTT) \\\u003C1.5 x ULN;\n* Negative serological testing for hepatitis B virus (HBV) (Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) negative) and hepatitis C virus (hepatitis C antibody). Subjects who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR within 6 weeks before enrollment. Those who are PCR positive will be excluded; Please note: For patients positive for anti-HBc HBV-DNA PCR has to be repeated every month until 12 months after last dose of study treatment.\n* Patient is able and willing to adhere to the study visit schedule and other protocol requirements;\n* Patient is capable of giving informed consent;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Any prior therapy with BTK inhibitor;\n* Prior treatment with venetoclax other than first line;\n* Other therapy with exception of chemo-\u002Fimmunotherapy which is allowed also after venetoclax first line relapse;\n* Transformation of CLL (Richter's transformation);\n* Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML);\n* Malignancies other than CLL currently requiring systemic therapy or not treated in curative intention or showing signs of progression after curative treatment;\n* Known allergy to xanthine oxidase inhibitors and\u002For rasburicase;\n* History of drug-specific hypersensitivity or anaphylaxis to any study drug (including active product or excipient components);\n* Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease);\n* Active fungal, bacterial, and\u002For viral infection that requires systemic therapy; Please note: active controlled as well as chronic\u002Frecurrent infections are at risk of reactivation\u002Finfection during treatment;\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled: infection, auto-immune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.);\n* Patient known to be HIV-positive;\n* Patient requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor\u002Finducer (see appendix J) or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists; Please note: Patients being treated with DOACs apixaban, edoxaban or rivaroxaban can be included, but must be properly informed about the potential risk of bleeding under treatment with acalabrutinib. (see appendix J)\n* History of stroke or intracranial hemorrhage within 6 months prior to registration;\n* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, myocardial infarction within 6 months) (CTCAE grade III-IV, see appendix D);\n* Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);\n* Severe neurological or psychiatric disease (CTCAE grade III-IV, see appendix D);\n* Patient who has difficulty with or are unable to swallow oral medication, or have significant gastrointestinal disease that would limit absorption of oral medication;\n* Vaccination with live vaccines within 28 days prior to registration;\n* Use of any other experimental drug or therapy within 28 days of registration;\n* Major surgery within 28 days prior to registration;\n* Steroid therapy within 10 days prior to registration, with the exception of inhaled steroids for asthma, topical steroids, steroids up to 20 mg or dose equivalents of prednisolone daily to control autoimmune phenomenon's, or replacement\u002Fstress corticosteroids;\n* Pregnant women and nursing mothers;\n* Fertile men or women of childbearing potential unless: (1) surgically sterile or ≥ 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method such as oral contraceptives, intrauterine device, sexual abstinence or combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) during study treatment and for 30 days after end of treatment;\n* Current participation in other clinical trial (other than follow up HOVON139\u002FHOVON140);\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":87,"type":20},60,[89],"PHASE2","Fixed-duration regimens containing combinations of venetoclax with CD20 targeting agents are expected to soon become standard practice in first-line patients with chronic lymfocytic leukemia (CLL). The advantage of a fixed duration venetoclax combination as part of first-line treatment is the potential to retreat with venetoclax in patients who develop relapsed disease after a treatment free period. However, efficacy of venetoclax retreatment following a fixed duration venetoclax combination is still hypothetical as clinical data are lacking. Thus, there is an urgent need for data proving efficacy of venetoclax combinations following venetoclax treatment cessation. Testing of a novel venetoclax-containing regimen for relapsed CLL without the repeat of anti-CD20 monoclonal antibody (mAb) is a rational approach.",[92],"CLL\u002FSLL",{"date":94,"type":37},"2026-01-06",{"date":96,"type":37},"2020-12-23",{"date":98,"type":20},"2032-12",{"name":43,"class":44},18,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100598709","phase-3-ivosidenib-and-azacitidine-with-or-without-venetoclax-in-adult-patients-with-newly-diagnosed-idh1-mutated-aml-or-mdsaml-considered-ineligible-for-intensive-chemotherapy-100598709","NCT07075016","Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS\u002FAML Considered Ineligible for Intensive Chemotherapy","EVOLVE 1","Inclusion Criteria:\n\n1. Patient with newly diagnosed IDH1-mutated AML, or IDH1-mutated MDS\u002FAML according to the 2022 International Consensus Classification (Appendix A). Patients with AML with both IDH1 and IDH2 mutation are eligible as well. Of note: in case both NPM1 and IDH1 are mutated and both EVOLVE-1 (HO173\u002FAMLSG 3423\u002FACT-HOV-AML-001) and EVOLVE-2 (HO177\u002FAMLSG 35-24\u002FACT-HOV-AML-002are open for inclusion at your site, then patients can only be included in the EVOLVE-1 trial (HO173)\n2. Central confirmation of IDH1 mutation in one of the dedicated central genetic laboratories.\n3. Age ≥ 18 years, no upper age limit.\n4. Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:\n\n   * older than or equal to 75 years of age ineligible for intensive chemotherapy per physician's discretion (with an ECOG performance status 0-2; Appendix C).\n   * 18-74 years: patient is not eligible for standard chemotherapy because of any of the following co-morbidities: o ECOG performance status 2 or 3 (Appendix C). o Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina.\n\n     * DLCO ≤ 65% or FEV1 ≤ 65%.\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C45 ml\u002Fmin calculated by the Cockcroft Gault formula.\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C 3.0 x upper limit of normal (ULN).\n     * Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy. If a patient meets this criterion, sponsor must be informed via HO173@erasmusmc.nl\n5. Patient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician).\n6. Patient must have a white cell blood (WBC) count of \\\u003C 25 x 109\u002FL. Hydroxyurea can be used prior to study enrollment to reduce the WBC count to meet this criterion.\n7. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of normal (ULN) or creatinine clearance \\>30 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR).\n8. Adequate hepatic function as evidenced by:\n\n   * Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease, or leukemic involvement. If a patient meets this criterion, sponsor must be informed via HO173@erasmusmc.nl Page 30 of 117 HOVON 173 AML \u002F AMLSG 34-23 \u002F ACT-HOV-AML-001 Version 1.1, UK 11 FEB 2025\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement. If a patient meets this criterion, sponsor must be informed via HO173@erasmusmc.nl\n9. Female patients :\n\n   * of nonchildbearing potential must be: o postmenopausal (defined as at least 1 year without any menses). o documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy or bilateral salpingectomy) or status posthysterectomy (at least 1 month prior to screening).\n   * of childbearing potential (not surgically sterile and not postmenopausal) must agree to avoid pregnancy during the study and for 6 months after the final study drug administration o and have a negative urine or serum pregnancy test at screening.\n\n     o and, if heterosexually active, agree to consistently apply one highly effective\\* method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration.\n   * must agree not to breastfeed starting at screening and throughout the study period, and for 1 month after the final study drug administration.\n   * must agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.\n10. Men must use a latex condom during any sexual contact with women of childbearing potential (WOCBP), even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control.\n11. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.\n12. Able to understand and willing to sign an informed consent form (ICF).\n13. Institutional Review Board\u002FIndependent Ethics Committee-approved written informed consent and privacy language as per national regulations must be obtained from the participant prior to any study-related procedures (including consent for withdrawal of prohibited medication, if applicable).\n\nExclusion Criteria:\n\n1. Subject has previously been treated for AML; a treatment period with hydroxyurea to control WBC counts is allowed; prior treatment with a hypomethylating agent for MDS-EB is not allowed; prior treatment with erythropoiesis-stimulating agents or luspatercept for MDS is allowed.\n2. Acute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations \u002F fusion genes.\n3. AML with BCR-ABL1; or myeloid blast crisis of CML\n4. Significant active cardiac disease within 3 months prior to the start of study treatment, including:\n\n   \\- New York Heart Association (NYHA) class III or IV congestive heart failure (Appendix F)\n\n   \\- Myocardial infarction\n\n   \\- Unstable angina\n   * Severe cardiac arrhythmias\n   * Congenital long QT syndrome of family member with this condition\n   * QTcF \\>480 msec on screening electrogram (mean of triplicate recordings).\n5. Familial history of sudden death or polymorphic ventricular arrhythmia.\n6. Severe obstructive or restrictive ventilation disorder.\n7. History of stroke or intracranial hemorrhage within 6 months prior to randomization.\n8. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.\n9. Active infection, including hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial; an infection controlled with an approved antibiotic\u002F antiviral\u002F antifungal treatment that is not a strong or moderate CYP3A inducer is allowed. Patients with COVID-19 infection can be enrolled, if the patient has no symptoms and was tested negative twice by PCR test prior to inclusion in the trial.\n10. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation.\n11. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs\n12. Patient with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C 30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n\n    * Basal or squamous cell carcinoma of the skin;\n    * Carcinoma in situ of the cervix;\n    * Carcinoma in situ of the breast;\n    * Incidental histologic finding of prostate cancer.\n13. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patient, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).\n14. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n15. Contraindication to any of the anti-leukemic agents used (as per SmPC). 16. Participation in other prospective studies with anti-leukemic and\u002For investigational agents.\n\n17\\. Patient taking Dabigatran unless they can be transferred to other medications within ≥5 half-lives prior to dosing. Patients taking other P-gP transporter-sensitive medications (see Appendix J) should be properly monitored during the study if they cannot be transferred to other medications.\" 18. Patients taking known strong cytochrome P450 (CYP) 3A4 inducers (see Appendix H), unless they can be transferred to other medications within ≥5 half-lives prior to dosing.\n\n19\\. The patient is a pregnant or lactating woman, or plans to become pregnant during the study.\n\n20\\. Patient who has once been screened and randomized into this HO173 trial but was considered ineligible cannot re-enter this trial at a later date.\n\n\\-",{"count":109,"type":20},227,[23],"The standard treatment for patients with acute myeloid leukemia (AML) with an abnormality in the IDH1 gene, who are not eligible for intensive chemotherapy, is a combination of ivosidenib and azacitidine. In this study it is investigated whether adding venetoclax to the standard treatment can improve the outcome of the treatment of this specific form of AML. The safety is investigated and how well it works. In order to properly assess the value of venetoclax, the effect of venetoclax is compared with the effect of a placebo. A placebo is a product without an active ingredient, a 'fake medicinal product'.",[26],[114,115,116],"IDH1","Newly AML diagnosed","Ineligible for intensive chemotherapy","2025-08-13",{"date":119,"type":37},"2025-08-19",{"date":121,"type":37},"2025-08-05",{"date":123,"type":20},"2029-03",{"name":43,"class":44},119,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100566227","phase-3-revumenib-in-combination-with-azacitidine--venetoclax-in-patients-npm1-mutated-or-kmt2a-rearranged-aml-100566227","NCT06652438","Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML","Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n1. Patient with newly diagnosed NPM1-mutated AML, consistent with NPM1c, according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts).\n\n   OR Patient with newly diagnosed KMT2A-rearranged AML according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts). KMT2A partial tandem duplications or deletions are NOT eligible.\n\n   Of note: in case both NPM1 and IDH1 are mutated and both EVOLVE-1 (HO173) and EVOLVE-2 (HO177) are open for inclusion at your site, then patients can only be included in the EVOLVE-1 trial (HO173)\n2. Central confirmation of NPM1 mutation or KMT2A rearrangement in one of the dedicated central genetic laboratories.\n3. Age ≥ 18 years, no upper age limit.\n4. Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:\n\n   * ≥ 75 years of age: ineligible for intensive chemotherapy per physician's discretion (with an ECOG performance status 0-2) .\n   * 18-74 years: patient is not eligible for standard chemotherapy because any of the following co-morbidities: o ECOG performance status 2 or 3 .\n\n     * Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina.\n     * DLCO ≤ 65% or FEV1 ≤ 65%.\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C45 ml\u002Fmin calculated by the Cockcroft Gault formula.\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C 3.0 x upper limit of normal (ULN).\n     * Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor's (co-) Principal Investigator (written approval must be sent to HO177@erasmusmc.nl before study enrolment).\n5. Patient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician).\n6. Patient must have a white cell blood (WBC) count of \\\u003C 25 x 109\u002FL. Hydroxyurea can be used prior to study enrolment to reduce the WBC count to meet this criterion.\n7. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \\>30 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR).\n8. Adequate hepatic function as evidenced by:\n\n   * Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease, or leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n9. Female patient must:\n\n   * be of nonchildbearing potential:\n\n     o postmenopausal (defined as at least 1 year without any menses).\n\n     o documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening).\n   * or, if of childbearing potential (not surgically sterile and not postmenopausal) agree to avoid pregnancy during the study and for 6 months after the final study drug administration.\n\n     o and have a negative urine or serum pregnancy test at screening.\n\n     o and, if heterosexually active, agree to consistently apply one highly effective\\* method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration.\n\n     \\*Highly effective forms of birth control include\n\n     \\- Consistent and correct usage of established hormonal contraceptives that inhibit ovulation for at least 1 month prior to taking study drug. (hormonal contraception is only a highly effective method of birth control, if a combined \\[estrogen and progestogen containing\\] hormonal contraception or a progestogen-only hormonal contraception - both associated with inhibition of ovulation - is used.\n\n     \\- Established intrauterine device (IUD) or intrauterine system (IUS)\n\n     \\- Bilateral tubal occlusion\n     * Vasectomy - a vasectomy is highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n     * Male is sterile due to a bilateral orchiectomy.\n     * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.\n\n   List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period.\n   * agree not to breastfeed starting at screening and throughout the study period.\n   * agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.\n10. Men must use a latex condom during any sexual contact with women of childbearing potential (WOCBP), even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control.\n11. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.\n12. Able to understand and willing to sign an informed consent form (ICF).\n13. Institutional Review Board\u002FIndependent Ethics Committee-approved written informed consent as per national regulations must be obtained from the patient prior to any study-related procedures (including consent for withdrawal of prohibited medication, if applicable).\n\nExclusion Criteria:\n\nSubject has previously been treated for AML; a treatment period with hydroxyurea to control WBC counts is allowed; prior treatment with a hypomethylating agent for MDS-EB is not allowed; prior treatment with erythropoiesis-stimulating agents or luspatercept for MDS is allowed.\n\n2\\. Acute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations \u002F fusion genes. 3. AML with BCR-ABL1; or myeloid blast crisis of CML. 4. Significant active cardiac disease within 3 months prior to the start of study treatment, including:\n\n* New York Heart Association (NYHA) class III or IV congestive heart failure\n* Myocardial infarction\n* Unstable angina\n* Severe cardiac arrhythmias\n* Congenital long QT syndrome of family member with this condition QTcF \\>450 msec on screening electrogram for males and \\>470msec on screening electrogram for females (mean of triplicate recordings; calculated using Fridericia's correction). 5. Severe obstructive or restrictive ventilation disorder. 6. History of stroke or intracranial hemorrhage within 6 months prior to randomization.\n\n  7\\. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening. 8. Active infection, including hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial; an infection controlled with an approved antibiotic\u002F antiviral\u002F antifungal treatment that is not a strong or moderate CYP3A inducer is allowed. Patients with COVID-19 infection can be enrolled, if the patient has no symptoms and was tested negative twice by PCR test prior to inclusion in the trial. 9. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation. 10. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n\n  11\\. Patient with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C 30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n* Basal or squamous cell carcinoma of the skin;\n* Carcinoma in situ of the cervix;\n* Carcinoma in situ of the breast;\n* Incidental histologic finding of prostate cancer. 12. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patient, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).\n\n  13\\. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n\n  14\\. Known or suspected hypersensitivity to any of the anti-leukemic agents used.\n\n  15\\. Participation in other prospective studies with anti-leukemic and\u002For investigational agents.\n\n  16\\. Patient taking Dabigatran unless they can be transferred to other medications within ≥5 half-lives prior to dosing. Patients taking other P-gP transporter-sensitive medications (see Appendix H) should be properly monitored during the study if they cannot be transferred to other medications.\n\n  17\\. Patient taking known strong cytochrome P450 (CYP) 3A4 inducers , unless they can be transferred to other medications within ≥5 half-lives prior to dosing. The patient is a pregnant or lactating woman, or plans to become pregnant during the study.\n\n  19\\. Patient who has once been screened and randomized into this HO177 trial but was considered ineligible cannot re-enter this trial at a later date.",{"count":134,"type":20},415,[23],"Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need. The combination therapy with two medicines, azacitidine and venetoclax, is the usual plan of action. This has brought significant progress in the treatment, but it nevertheless is not curative and the disease does relapse over time.\n\nRevumenib blocks a specific molecule called menin in the cell nucleus. Some types of AML are reliant on menin working properly. These are leukemia cells with a change in the DNA, i.e. a mutation in the NPM1 or KMT2A gene. Revumenib can prevent the production of these types of leukemia cells by disrupting the production of this menin.\n\nThe current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene.\n\nThis is a randomized, double-blind, placebo-controlled clinical study where subjects will be treated until disease progression, or development of side effects or death. From the moment of inclusion of the last patient, there will be a 4-year observational follow-up study in order to register survival duration and follow-up visits.\n\nApproximately 415 previously untreated patients with a mutation in the NPM1 or KMT2A gene and with newly diagnosed AML, who are not eligible for intensive chemotherapy. Patients must be ≥18 years of age.",[138],"Acute Myeloid Leukemia, Adult",[140,31,32],"newly AML diagnosed","2025-04-03",{"date":143,"type":37},"2025-04-04",{"date":145,"type":37},"2025-03-31",{"date":147,"type":20},"2031-07-10",{"name":43,"class":44},67,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100562624","phase-1-tasquinimod-in-patients-with-myelofibrosis-refractory-to-or-intolerant-for-jak2-inhibition-100562624","NCT06605586","Tasquinimod in Patients with Myelofibrosis Refractory to or Intolerant for JAK2 Inhibition","A Phase 1b\u002F2 Trial with Tasquinimod in Patients with Myelofibrosis (primary, Post-PV or PostET) Refractory to or Intolerant for JAK2 Inhibition: the TasqForce Trial","HOVON 172 MF","Inclusion Criteria:\n\n* Diagnosis of PMF or Post-PV MF or Post-ET MF based on a bone marrow (BM) biopsy not older than 6 months, according to the 2016 World Health Organization.\n* Refactory or intolerant to treatment with an approved JAK inhibitor or ineligible for JAK inhibitor treatment.\n* MF classified as Intermediate-1 with disease-related symptoms (e.g. symptomatic splenomegaly), Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System Plus\n* Spleen ≥5 cm below costal margin as measured by palpation.\n* Age ≥18 years.\n* Peripheral blood blast count of \\\u003C10%.\n* WHO\u002FECOG performance status of 0, 1, or 2.\n* Able to swallow and retain oral medication.\n* Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n* Negative pregnancy test at study entry for women of childbearing potential. Women of child-bearing potential and sexually active males must be willing and able to use highly effective methods of contraception, during treatment, and for 4 months and 6 months respectively, after study treatment.\n* Patient is capable of giving informed consent.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).\n* Splenectomy.\n* Splenic irradiation within the last 6 months.\n* Prior allogeneic stem cell transplantation.\n* Following laboratory values within 14 days prior to registration:\n\n  * Absolute Neutrophil Count (ANC) \\\u003C0.5 x 109\u002FL without G-CSF support\n  * Platelet count \\\u003C25 x 109\u002FL without platelet transfusion\n  * Serum creatinine \\>1.5 x Upper limit of normal (ULN) or GFR \\\u003C30 ml\u002Fmin\n  * Serum amylase and lipase \\>1.5 x ULN\n  * Alanine aminotransferase (ALT) ≥2.5 x ULN\n  * Total bilirubin \\>1.5 times the upper limit of the normal range (ULN), unless elevated bilirubin is due to unconjugated hyperbilirubinemia from Gilbert's syndrome or related to MF\n* Known active (acute or chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers, HIV.\n* Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis).\n* Patients with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years.\n* Failure to have fully recovered (i.e. to CTCAE Grade 1 or previous baseline) from clinically significant adverse effects of prior chemotherapy (examples of adverse effects that are not clinically significant include alopecia and lymphopenia).\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of tasquinimod (e.g., ulcerative diseases, pancreatitis uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).\n* Evidence of severe or currently uncontrolled cardiovascular condition (e.g. cardiac amyloidosis, pulmonary embolism, angina, hypertension, peripheral vascular disease, congestive heart failure class III or IV of the NYHA classification (appendix F), cardiac arrhythmia, acute coronary syndrome, myocardial infarction, cerebrovascular accident, major hemorrhage, intracranial hemorrhage, transient ischemic attack, or limb claudication) within 6 months prior to registration.\n* Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening\u002F enrollment until the course of antibiotic therapy has been completed.\n* Any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), anagrelide, immunosuppressive therapy, corticosteroids \\>10 mg\u002Fday prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 2 weeks prior to initiation of tasquinimod; erythropoetin use within 28 days prior to initiation of tasquinimod. The only chemotherapy allowed will be hydroxyurea which has to be stopped within 1 day prior to initiation of tasquinimod.\n* Treatment with fedratinib within 7 days, or momelotinib within 2 days prior to initiation of tasquinimod. For ruxolitinib no wash-out period is required before start of tasquinimod.\n* Any investigational treatment for MF within 2 weeks or 5 half-lives whichever is shorter.\n* History of severe hypersensitivity reaction to any component of tasquinimod.\n* Systemic treatment within 14 days prior to the initiation of tasquinimod with any of the moderate or strong inhibitor, or moderate or strong inducer of cytochrome P-3A4 (CYP3A4)\n* Need for ongoing therapy with drug substances of narrow therapeutic range that are metabolized mainly by CYP3A4\n* Need for ongoing therapy with drug substances of narrow therapeutic range metabolized mainly by CYP1A2\n* Ongoing treatment with vitamin K antagonist, unless the INR is ≤ 3.0\n* Prior treatment with tasquinimod.\n* Major surgery within 3 months.\n* Pregnant or breast feeding (lactating) women.\n* Any other condition that would, in the Investigator's judgment, contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures e.g. any uncontrolled disease such as pulmonary disease, infection or seizure disorder; intestinal obstruction, inability to swallow medication, any altered mental status or psychiatric condition that would interfere with the understanding of the informed consent\n* Current participation (during interventional treatment) in another clinical trial.\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":159,"type":20},20,[161,89],"PHASE1","The goal of this clinical trial is to learn if therapy can be improved in patients with myelofibrosis (MF) who have primary resistance or who have progressed after treatment with a Janus kinase (JAK) inhibitor or are intolerant for this category of drugs.\n\nThe main questions it aims to answer are:\n\n* To evaluate the feasibility and safety of once daily dose of tasquinimod for 24 weeks (6 cycles)\n* To determine the optimal dose\n\nPatients will be treated once daily with tasquinimod for a maximum period of 24 weeks (6 cycles).\n\nDuring the study most (diagnostic) procedures are part of the standard of care. Different from standard of care:\n\n* Participation may lead to extra visits to the outpatient clinic\n* Additional blood will be drawn when blood is already taken per standard of care\n* Bone marrow sampling at entry and at the end of the trial\n* MRI scans (or CT-scans) have to be performed\n* Quality-of-life questionnaires have to be filled out",[164],"Myelofibrosis","2025-03-05",{"date":167,"type":37},"2025-03-07",{"date":169,"type":37},"2025-02-20",{"date":171,"type":20},"2030-03",{"name":43,"class":44},6,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100530489","phase-3-feasibility-of-a-treatment-free-interval-in-newly-diagnosed-mm-patients-treated-with-daratumumab-lenalidomide-dexamethasone-hovon174mm-100530489","NCT06187441","FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)","FeAsiBility of a Treatment Free Interval in Newly Diagnosed mUltiple myeLOma Patients Treated With DaratumUmab-Lenalidomide-DexamethaSone- the FABULOUS Study. A Nationwide Open-label Randomized Phase III Clinical Trial Comparing Daratumumab-lenalidomide-dexamethasone Continuously Versus Including a Treatment Free Interval","HOVON174MM","Inclusion Criteria:\n\n* Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease at the time of diagnosis (appendix A).\n* Age ≥ 18 years.\n* Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and will continue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to less than 5 mg, and previous discontinuation or dose reduction of dexamethasone is allowed.\n* Partial response or better after treatment with 12 cycles of Dara-Rd, without signs of biochemical progression.\n* ANC ≥ 1.0x109\u002FL and platelets ≥ 75x109\u002FL.\n* Patient is capable of giving informed consent.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patient with non-secretory MM at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.\n* Patient in whom a plasmacytoma was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.\n* Patient in whom urine M-protein was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.\n* Patient in whom treatment with daratumumab, lenalidomide or both has been discontinued for whatever reason (patients may only have discontinued dexamethasone).\n* Patient in whom continuation of treatment with Dara-Rd is deemed not feasible because of medical reasons.\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":183,"type":20},599,[23],"In the Netherlands, the standard treatment for multiple myeloma is a combination of different medicines named daratumumab-lenalidomide-dexamethasone, abbreviated as Dara-Rd. In many patients this treatment results in suppressing the disease for a long time. The treatment is continued until it is not effective anymore and the disease progresses.\n\nBut until now it is unknown whether continuous therapy also leads to prolonging life. In addition, there are concerns about side effects, leading to a reduced quality of life, the development of severe toxicity that remains, which hampers subsequent therapy, and high costs due to prolonged treatment.\n\nThere are indications that temporarily stopping treatment is safe, leading to fewer side effects and allows recovering from toxicity or damage due to treatment. This may improve the quality of life.",[187],"Multiple Myeloma",{"date":189,"type":37},"2024-08-19",{"date":191,"type":37},"2024-05-14",{"date":193,"type":20},"2037-12",{"name":43,"class":44},38,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100500065","phase-1-venetoclax-treatment-26-cycles-with-6-cycles-or-12-cycles-of-epcoritamab-in-patients-with-relapsed-or-refractory-cll-or-sll-100500065","NCT05791409","Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL","A Prospective Randomized Phase I\u002FII Trial of Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","AETHER","Inclusion Criteria:\n\n* Documented relapsed or refractory CLL or SLL (SLL in phase II part only) following at least one systemic 1st-line treatment\n* Requiring treatment according to IWCLL criteria (appendix A);\n* Age at least 18 years;\n* ECOG\u002FWHO performance status 0-2;\n* In case of prior venetoclax treatment, enrollment can only occur at least 24 months after end of treatment and patients must not have progressed during venetoclax treatment;\n* Adequate BM function defined as:\n\n  * Hemoglobin \\>5.6 mmol\u002Fl or Hb \\> 9 g\u002FdL, unless low Hb is directly attributable to CLL infiltration of the BM, proven by BM biopsy;\n  * Absolute neutrophil count (ANC) \\>1.0 x 109\u002FL (1,000\u002FμL), unless low ANC is directly attributable to CLL infiltration of the BM, proven by BM biopsy;\n  * Platelet count \\>30 x 109\u002FL (30,000\u002FμL), unless low platelets is directly attributable to CLL infiltration in the BM;\n* Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl) ≥ 50ml\u002Fmin (Cockcroft-Gault appendix F);\n* Adequate liver function as indicated:\n\n  * Serum aspartate transaminase (ASAT) and alanine transaminase (ALAT) ≤ 3.0 x upper limit of normal (ULN);\n  * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or controlled autoimmune hemolytic anemia);\n* Prothrombin time (PT)\u002FInternational normal ratio (INR) \\\u003C1.5x ULN and activated partial thromboplastin time (aPTT) \\\u003C1.5 x ULN; unless receiving anticoagulation;\n* Negative serological testing for hepatitis B virus (HBV) (Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) negative) and hepatitis C virus (hepatitis C antibody). Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR within 6 weeks before enrollment. Those who are PCR positive will be excluded; Please note: For patients positive for anti-HBc, HBV-DNA PCR has to be repeated every month until 12 months after last dose of study treatment.\n* Patient is able and willing to adhere to the study visit schedule and other protocol requirements;\n* Patient is capable of giving informed consent;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Active CLL\u002FSLL directed therapy within the last 14 days;\n* Prior treatment with a CD3 × CD20 bispecific antibody or CAR T-cell therapy\n* Transformation of CLL (Richter's transformation);\n* Prior allogeneic stem cell transplantation and\u002For solid organ transplantation;\n* Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML);\n* Malignancies other than CLL currently requiring systemic therapy or not treated in curative intention or showing signs of progression after curative treatment;\n* Known allergy to xanthine oxidase inhibitors and\u002For rasburicase;\n* History of drug-specific hypersensitivity or anaphylaxis to any study drug (including active product or excipient components);\n* Active bleeding or uncontrolled severe bleeding diathesis (e.g., hemophilia or severe von Willebrand disease);\n* Active fungal, bacterial, and\u002For viral infection CTCAEgrade \\> 1; Please note: active controlled as well as chronic\u002Frecurrent infections are at risk of reactivation\u002Finfection during treatment;\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled: infection, auto-immune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.);\n* Patient known to be HIV-positive;\n* Patient requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor\u002Finducer (see appendix J) or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists;\n* CTCAE grade III-IV cardiovascular disease including but not limited to:\n\n  * Unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function, eg, unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association (see appendix E), uncontrolled clinically significant cardiac arrhythmia (CTCAE grade II or higher), or clinically significant electrocardiogram (ECG) abnormalities.\n  * Myocardial infarction, intracranial bleed, or stroke within the past 6 months.\n  * Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \\>480 msec. NOTE: this criterion does not apply to subjects with a left bundle branch block.\n  * Stroke or intracranial hemorrhage within 6 months prior to registration.\n* Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);\n* Severe neurological or psychiatric disease (CTCAE grade III-IV, see appendix D);\n* Neuropathy \\> CTCAE grade II\n* Patient who has difficulty with or are unable to swallow oral medication, or have significant gastrointestinal disease that would limit absorption of oral medication;\n* Vaccination with live vaccines within 28 days prior to registration;\n* Use of any other experimental drug or therapy within 28 days of registration;\n* Major surgery within 28 days prior to registration;\n* Pregnant women and nursing mothers;\n* Fertile men or women of childbearing potential unless: (1) surgically sterile or ≥ 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method such as oral contraceptives, intrauterine device, sexual abstinence or combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) during study treatment and for 12 months after last dose of epcoritamab and 30 days after last dose of venetoclax;\n* Previous participation in the HOVON 139 CLL or HOVON 140 CLL trial and eligible for and willing to participate in the HOVON 159 CLL trial;\n* Current participation in other clinical trial with medicinal products;\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":205,"type":20},112,[161,89],"In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed\u002Frefractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.",[92],"2024-04-10",{"date":211,"type":37},"2024-04-12",{"date":209,"type":37},{"date":214,"type":20},"2032-11",{"name":43,"class":44},24,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":100},"100517203","phase-2-a-trial-to-assess-cobicistat-boosted-venetoclax-in-combination-with-azacitidine-in-adult-patients-with-newly-diagnosed-aml-100517203","NCT06014489","A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML","A Single Arm Phase II Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine (sc) in Adult Patients With Newly Diagnosed Acute Myeloid Leukaemia (AML) Who Are Not Considered Candidates for Intensive Treatment Regimens","HO171","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n* Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia) (appendix A). Patients may have had previous treatment with erythropoiesis stimulating agents (ESA) for an antecedent phase of MDS. ESAs must be stopped at least two weeks before registration.\n* Patients 18 years and older who are considered not fit for intensive chemotherapy or who decline the option of intensive chemotherapy.\n* WHO performance status 0, 1 or 2 (appendix E).\n* Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:\n\n  * Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.\n  * Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert's syndrome.\n  * Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related.\n* Male subjects who are sexually active, must agree, from Study Day 1 until at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.\n* Female subjects must be either postmenopausal defined as: Age \\>55 years with no menses for ≥12 months, without an alternative medical cause. OR willing and able to use adequate contraception during and until 180 days after the last protocol treatment.\n* Written informed consent.\n* Patient is capable of giving informed consent.\n* Patient agrees not to participate in another interventional study while on treatment without approval of the (co-) Principal Investigator.\n\nExclusion Criteria:\n\nA patient who meets any of the following criteria cannot be included in this study:\n\n* Acute promyelocytic leukemia.\n* Myelodysplastic syndrome (MDS).\n* Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating agents (ESAs); 2) hydroxyurea (hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis).\n* Diagnosis of any previous or concomitant malignancy is an exclusion criterion:\n\n  * except when the patient successfully completed treatment (chemotherapy and\u002For surgery and\u002For radiotherapy) with curative intent for this malignancy at least 24 months prior to registration;\n  * except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.\n* Blast crisis of chronic myeloid leukemia.\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.).\n* Cardiac dysfunction as defined by:\n\n  * Myocardial infarction within the last 3 months of study entry, or\n  * Reduced left ventricular function with an ejection fraction \\\u003C 40% as measured by MUGA scan or echocardiogram, or\n  * Unstable angina or New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix G), or\n  * Unstable cardiac arrhythmias.\n* History of stroke or intracranial haemorrhage within 6 months prior to registration.\n* Symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement).\n* History of non-compliance to medical regimens or considered unreliable with respect to compliance.\n* Senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Unreplaceable use of strong inhibitors or inducers of CYP3A or CYP3A\u002Fp-GP substrates with a narrow therapeutic window (e.g. cobicistat or ritonavir for HIV treatment). Please check with Appendix I.\n* Intolerability, contra-indication or allergy to one of the study drugs.",{"count":226,"type":20},142,[89],"The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.",[230],"AML, Adult","2024-01-17",{"date":233,"type":37},"2024-01-18",{"date":231,"type":37},{"date":236,"type":20},"2028-03",{"name":43,"class":44},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100313100","phase-1-phase-i-ii-study-in-cd30-positive-diffuse-large-b-cell-lymphoma-patients-refractory-to-first-line-chemotherapy-or-in-first-relapse-100313100","NCT03356054","Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse","Phase I-II Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (R-DHAP) in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Stem Cell Transplantation","HOVON 136 NHL","Inclusion Criteria:\n\n* CD30 positive DLBCL, i.e. more than 1% of DLBCL cells CD30 positive(central pathology review results not required to enter patient into the study), according to the WHO classification 2008:\n\n  * CD30 positive DLBCL, including EBV positive DLBCL\n  * CD30 positive primary mediastinal B-cell lymphoma\n* Primary refractory to or in first relapse after first line therapy with R-CHOP or R-CHOP-like therapy\n\n  * Relapse is defined as biopsy confirmed CD30 positive DLBCL after a complete response. The relapse must be histologically confirmed. In case a surgical biopsy is not possible, at least confirmation by FNA biopsy is required\n  * Refractory disease is defined as:\n\n    1. progressive disease during first line therapy, In this case biopsy confirmation of CD30 positive DLBCL is preferred but not required\n    2. stable disease after at least 3 cycles of first line therapy, In this case biopsy confirmation of CD30 positive DLBCL is preferred but not required\n    3. PR after at least 6 cycles of first line therapy, or in the case of stage I-II disease after at least 3 cycles of therapy and definitive involved field radiotherapy. In this case refractory disease must be histologically confirmed\n* Age ≥ 18 years (upper age limit for ASCT at the discretion of the participating center)\n* Measurable disease: on CT scan at least 1 lesion\u002Fnode with a long axis of \\> 1.5 cm and at least one positive lesion on 18F-FDG PET scan\n* WHO performance status 0-2, status 3 only if disease related (see appendix C)\n* Adequate hepatic function: total bilirubin ≤ 1.5 times ULN (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome as defined by \\> 80% unconjugated bilirubin) and ALAT\u002FASAT ≤ 3 times ULN (unless due to lymphoma involvement of the liver; in that case ALAT\u002FASAT may be elevated up to 5 times ULN)\n* Adequate renal function: GFR \\> 60 ml\u002Fmin as estimated by the Cockroft\\&Gault formula at rehydration: CrCL = (140-age \\[in years\\] x weight \\[kg\\] (x 0.85 for females) \u002F (0.815 x serum creatinine \\[μmol\u002FL\\])\n* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5x109\u002FL and platelet count ≥ 100 x 109\u002FL, unless caused by diffuse bone marrow infiltration by the NHL\n* Hemoglobin must be ≥ 8 g\u002FdL (5.0 mmol\u002FL), transfusion is allowed\n* Eligible for high-dose chemotherapy and ASCT\n* Resolution of relevant toxicities from first-line therapy\n* Life expectancy of \\> 3 months with treatment\n* Negative pregnancy test at study entry, if applicable\n* Female patient is either post-menopausal for at least 1 year before screening visit or surgically sterile or if of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, or agrees to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months after the last dose of study drug\n* Male patients, even if surgically sterilized, (i.e. status post vasectomy) agree to practice effective barrier contraception, or agrees to completely abstain from heterosexual intercourse, during the entire study period and through 12 months after the last dose of study drug\n* Written informed consent\n* Patient is capable of giving informed consent\n\nExclusion Criteria:\n\n* Peripheral sensory or motor neuropathy grade ≥ 2\n* Known cerebral or meningeal disease (NHL or any other etiology), including signs and symptoms of progressive multifocal leukoencephalopathy (PML)\n* Symptomatic neurological disease compromising normal activities of daily living or requiring medications\n* Transformed lymphoma\n* DLBCL after organ transplantation\n* Immunodeficiency-associated B-cell lymphoproliferative disease\n* Use of other investigational agents within at least 5 half-lives of the most recent agent used prior to study entry\n* Treatment with myelosuppressive chemotherapy or biological therapy ≤ 4 weeks before study entry\n* Female patients who are breast feeding\n* History of another malignancy less than 3 years before study inclusion, or previously diagnosed with another malignancy and have evidence of residual disease, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of the uterine cervix\n* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin\n* Active hepatitis B or C infection as defined by positive serology and transaminitis. Non-active hepatitis B carriers or anti-HBc positive patients may be included if protected with lamuvidine or entecavir (see 9.4)\n* HIV positivity\n* Radiation therapy within 8 weeks prior to start of protocol treatment. Emergency radiation therapy is allowed, as long as measurable disease (at non-irradiated sites) persists\n* Patients with a serious psychiatric disorder that could, in the investigator's opinion, potentially interfere with the completion of treatment according to protocol\n* Major organ dysfunction, unless NHL-related\n* Patients who have any severe and\u002For uncontrolled medical condition or other conditions that could affect their participation in the study such as:\n\n  * Known history of symptomatic congestive heart failure (NYHA III, IV, appendix E), myocardial infarction ≤ 6 months prior to first study drug\n  * Evidence of current serious uncontrolled cardiac arrhythmia, angina pectoris, electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n  * Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction \\\u003C45%\n  * Severely impaired pulmonary function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% or less of the normal predicted value and\u002For O2 saturation that is 90% or less at rest on room air\n* Thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication\n* Current participation in another clinical trial interfering with this trial\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Claustrophobia to the extent that PET-CT is impossible",{"count":247,"type":20},37,[161,89],"Patients with CD30 positive DLBCL, primary refractory or in first relapse after R-CHOP or R-CHOP-like therapy will receive brentuximab vedotin in combination with R-DHAP, followed in responsive patients by high dose chemotherapy and ASCT.",[251],"DLBCL","2020-12-09",{"date":254,"type":37},"2020-12-10",{"date":256,"type":37},"2018-03-05",{"date":258,"type":20},"2027-02",{"name":43,"class":44},1,""]