[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PETHEMA Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":279},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,68,93,123,149,179,203,229,255],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100557951","phase-2-zanubrutinib-with-obinutuzumab-in-untreated-patients-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100557951",false,"NCT06544785","Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","A Multicenter, Phase 2 Randomized, Open Label Study to Evaluate Zanubrutinib in Combination With Obinutuzumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (GELLC-10-ZANUBIO)","Inclusion Criteria:\n\n1. Adult patients with previously untreated CLL defined following IWCLL criteria (Hallek, 2018).\n2. Must understand and voluntarily sign an informed consent form.\n3. Age ≥ 18 years at the time of signing the informed consent form and must be able to adhere to the study visit schedule and other protocol requirements.\n4. Must have a documented diagnosis of CLL or SLL \\[IWCLL guidelines for diagnosis and treatment of CLL (Hallek, 2018)\\] meeting at least one of the following criteria:\n\n   * Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and\u002For thrombocytopenia.\n   * Massive (i.e. ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.\n   * Massive nodes (i.e. ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.\n   * Progressive lymphocytosis with an increase of ≥50% over a 2-month period, or lymphocyte doubling time (LDT) of less than 6 months.\n   * A minimum of any one of the following disease-related symptoms: unintentional weight loss ≥ 10% within the previous 6 months, significant fatigue (i.e., ECOG PS 2 or worse; cannot work or unable to perform usual activities), fevers of greater than 38.0°C for 2 or more weeks without other evidence of infection, or night sweats for more than 1 month without evidence of infection.\n   * Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids.\n   * Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine).\n5. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.\n6. Female patients of childbearing potential must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib and 18 months after last dose of obinutuzumab.\n\n   Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with other applicable highly effective methods described below during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib and 18 months after last dose of obinutuzumab.\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. Contraception methods include the following:\n   * Combined (estrogen- and progestogen- containing) hormonal contraception associated with the inhibition of ovulation - Oral, intravaginal, or transdermal.\n   * Progestogen-only hormonal contraception associated with the inhibition of ovulation - Oral, injectable, implantable.\n   * An intrauterine device.\n   * Intrauterine hormone-releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the woman of childbearing potential study participant and that the vasectomized partner has received medical assessment of surgical success).\n   * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib or ibrutinib. Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational medicinal product, and withdrawal are not acceptable methods of contraception.\n\n   Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception, and, if used, this method must be used in combination with another acceptable method listed above.\n\n   If patient is using hormonal contraceptives such as birth control pills or devices, a barrier method of contraception (eg, condoms) must also be used.\n\n   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle-stimulating hormone measurement is insufficient.\n7. Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of child bearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.\n\nExclusion Criteria:\n\n1. Prior treatment for CLL.\n2. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and\u002For Hepatitis C Virus (HCV) infection. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative could be eligible if they have an undetectable HBV DNA (negative polymerase chain reaction (PCR) \\\u003C20 IU). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.\n\n   Per published guidelines (NCCN 2012) or institutional guidelines, patients should be closely monitored for hepatitis B reactivation. Obtaining repeated hepatitis B PCR every 3 months during treatment and for the 12 months after last dose of study drug according to usual clinical practice in order to monitor for reactivation of hepatitis B is recommended.\n3. Estimated Glomerular Filtration Rate (Cockcroft-Gault Appendix C) ≤30 mL\u002Fmin\u002F1.73m2.\n4. Absolute neutrophil count (ANC) \\\u003C 1.0 X 109\u002FL.\n5. Platelet count \\\u003C 75 X 109\u002FL, except for patients with bone marrow involvement by CLL in which case the platelet count must be ≥ 30 X 109\u002FL.\n6. Serum aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)\u002Fserum glutamate pyruvate transaminase (SGPT) \\>2.5 x upper limit of normal (ULN).\n7. Serum total bilirubin \\> 1.5 x ULN, except in cases of Gilbert's syndrome.\n8. Prothrombin time\u002FINR or aPTT (in the absence of Lupus anticoagulant) \\> 2x ULN.\n9. Active bleeding, history of bleeding diathesis (eg, haemophilia or von Willebrand disease).\n10. Unable to swallow capsules, or has disease significantly affecting gastrointestinal function that would limit absorption of oral medication.\n11. Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 3 months prior to enrollment. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening can enrol on study.\n12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.\n13. Systemic infection that has not resolved prior to initiating study treatment in spite of adequate anti-infective therapy.\n14. Pregnant or lactating females.\n15. Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.\n16. Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.\n17. Prior history of malignancies, other than CLL, unless the patient has been free of the disease for ≥ 3 years.\n\n    Exceptions include the following:\n    * Basal cell carcinoma of the skin\n    * 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 (TNM stage of T1a or T1b)\n18. Presence of autoimmune haemolytic anaemia or autoimmune thrombocytopenia.\n19. Major surgery within the last 28 days prior to registration.\n20. History of stroke or intracranial haemorrhage within 6 months prior to enrollment.\n21. Requires treatment with strong CYP3A4\u002F5 Inhibitors.\n22. Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components).\n23. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk.","ALL","18 Years",{"count":19,"type":20},106,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this phase II randomized open label study is to compare the rate of complete remission (CR) with undetectable minimal residual disease (uMRD) obtained with zanubrutinib in combination with obinutuzumab with two different schedules of administration of obinutuzumab (starting obinutuzumab at cycle 2 or 12 months) in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). There is scarce information about which is the most appropriate schedule of combining the BTKi and the anti-CD20 monoclonal antibody, and whether treatment can be safely stopped in those patients attaining deep responses (CR with uMRD) remains to be determined.\n\nResponse will be assessed after 20 cycles of treatment for the primary objective of the study. Patients attaining uMRD will stop treatment with zanubrutinib, whereas the rest of patients will continue on treatment with zanubrutinib until progression, unacceptable toxicity, or trial completion, whichever comes first.",[26,27],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma",[29,30,31],"zanubrutinib","obinutuzumab","untreated CLL\u002FSLL","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":36},"2024-09-02",{"date":40,"type":20},"2032-05-31",{"name":42,"class":43},"PETHEMA Foundation","OTHER",19,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100482153","phase-3-ndmm-patients-candidates-for-asct-comparing-extended-vrd-plus-vs-isa-vrd-vs-isa-v-iberdomide-100482153","NCT05558319","NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide","GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D","GEM21menos65","Inclusion Criteria:\n\n1. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.\n2. Patient must be able to understand the study procedures.\n3. Patient has given voluntary written informed consent before performance of any studyrelated procedure non part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.\n4. Newly diagnosed multiple myeloma patient who requires start active treatment according to the 2014 IMWG criteria, namely clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events: evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia, Anaemia, Renal Insufficiency, or Bone lesions (one or more osteolytic lesions on skeletal radiography, CT, or PET-CT), and any one or more of the following biomarkers: clonal BMPC% ≥60%, i\u002Fu free light ratio ≥100 or \\> 1 focal lesions on MRI or PET\u002FCT) \\[Lancet Oncol. 2014;15(12): e538-e548\\].\n5. Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g\u002Fdl or urine monoclonal (light chain) protein ≥ 200 mg\u002F24 h. For patients whose disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg\u002FdL (100 mg\u002FL), with an abnormal serum FLC ratio.\n6. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n7. Patient must be ≤ 65 years of age.\n8. Patient must have adequate organ function, defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥1.0 X 109\u002FL without G-CSF use in the prior 7 days\n   * Hemoglobin ≥8.0 g\u002FdL (prior red blood cell (RBC) transfusion or recombinant human erythropoietin use is permitted)\n   * Platelets ≥ 75 x 109\u002FL in participants in whom \\\u003C50% of bone marrow nucleated cells are plasma cells and ≥ 50×109\u002FL in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test).\n   * Calcium Corrected serum calcium ≤13.5 mg\u002FdL (≤3.4 mmol\u002FL); or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL).\n   * Total bilirubin ≤2 X ULN\n   * ALT ≤2.5 X ULN\n   * AST ≤2.5 X ULN\n   * Renal: eGFRa: ≥40 mL\u002Fmin\u002F 1.73 m2\n   * Cardiac: LVEF (echo) ≥ 50%\n9. Female patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a woman of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy OR\n   * Is a WOCBP and\n\n     * She understands the potential teratogenic risk to the unborn child\n     * She understands the need for effective contraception as stated in the protocol, without interruption, 28 days before starting study treatment, throughout the entire duration of study treatment, during dose interruptions and for at least 28 days after the last dose of study treatment.\n     * She understands and agrees to inform the Investigator if a change or stop of method of contraception is needed.\n     * She must be capable of complying with effective contraceptive measures.\n     * She is informed and understands the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy.\n     * She understands the need to commence study treatment as soon as it is dispensed following a negative pregnancy test.\n     * She understands and accepts the need to undergo pregnancy testing based on the frequency outlined in this plan and in the Informed Consent.\n     * She acknowledges she understands the hazards iberdomide or lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of study drugs.\n\n   The Investigator must ensure that a WOCBP: i) Complies with the conditions of the pregnancy prevention plan, including confirmation that she has an adequate level of understanding. ii) Acknowledges the aforementioned requirements.\n\n   A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study drug.\n\n   Nonchildbearing potential is defined as follows (by other than medical reasons):\n   * Has not achieved menarche at some point.\n   * Has undergone a hysterectomy or bilateral oophorectomy.\n   * Has been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).\n10. Male patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n    Male patient is eligible to participate if he agrees to the following from the time of first dose of study until 6 months after the last dose of iberdomide or lenalidomide to allow for clearance of any altered sperm:\n    * Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a WOCBP.\n    * Understand the need for the use of a condom even if he has had a vasectomy, if engaged in sexual activity with a pregnant female or a FCBP\n    * Understand the potential teratogenic risk, so the subject should not donate semen or sperm.. Understand that the effects on fertility are currently unknown, therefore all family planning options and\u002For alternatives should be thoroughly discussed with the study doctor prior to receiving iberdomide.\n11. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 must be ≤ Grade 1 at the time of enrolment except for alopecia.\n\nExclusion Criteria:\n\n1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia or active POEMS syndrome at the time of screening.\n2. Patient has had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma.\n3. Prior history of malignancies, other than multiple myeloma (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or the breast), unless the patient has been free of the disease for ≥ 5 years.\n4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and\u002For lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.\n5. Pregnant or breastfeeding females.\n6. Men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception).\n7. Patient is simultaneously enrolled in other interventional clinical trial.\n8. Patient has used an investigational drug within 28 days or five half-lives, whichever is longer, preceding the first dose of study drug.\n9. Patient must not have received prior radiotherapy (except localized palliative radiotherapy for pain, palliation or fracture) within 2 weeks of start of study therapy. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n10. Major surgery (except kyphoplasty) ≤ 4 weeks prior to initiating protocol therapy.\n11. Patient has peripheral neuropathy or neuropathic pain grade 1 with pain or ≥2, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.\n12. Patient evidence of cardiovascular risk including any of the following:\n\n    * Myocardial infarction within 6 months before randomization, or an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV).\n    * Uncontrolled cardiac arrhythmia.\n    * Screening 12-lead ECG showing a baseline interval QTcF\\> 470 msec (exception: subjects with pacemaker).\n    * Patients with uncontrolled hypertension.\n13. Patients who have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.\n14. Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria.\n15. Evidence of active mucosal or internal bleeding.\n16. Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form.\n17. Uncontrolled endocrine diseases (i.e. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).\n18. Patient with acute diffuse infiltrative pulmonary disease and\u002For pericardial disease.\n19. Patient with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEV1) less than 50%.\n20. History of interstitial lung disease or ongoing interstitial lung disease.\n21. Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and\u002For other oral study treatment.\n22. Patient has an active infection requiring systemic antibiotic, antiviral, or antifungal treatment at the time of starting treatment.\n23. Patient has known HIV infection.\n24. Patient has positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment.\n25. Patient has positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required.\n26. Patient require concurrent administration of a strong inhibitor or inducer of cytochrome P450 (CYP3A4\u002F5) (including within 14 days of initiating study treatment).\n27. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to iberdomide or drugs chemically related to iberdomide.\n28. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to isatuximab or drugs chemically related to isatuximab, hypersensitivity reactions, or idiosyncratic reactions to other molecular antibodies.\n29. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to lenalidomide or dexamethasone or drugs chemically related to lenalidomide or dexamethasone.","65 Years",{"count":55,"type":20},480,[57],"PHASE3","This is a Phase III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation. Patients will be randomized from 3 arms. Patients will receive VRD extended + ASCT plus ERI or Isatuximab-VRD + ASCT or Isatuximab-VID + ASCT.",[60],"Newly Diagnosed Multiple Myeloma",{"date":35,"type":36},{"date":63,"type":36},"2022-11-10",{"date":65,"type":20},"2029-04",{"name":42,"class":43},68,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100641132","study-to-evaluate-efficacy-and-safety-of-belantamab-based-combinations-for-relapsed-multiple-myeloma-100641132","NCT07637526","Study to Evaluate Efficacy and Safety of Belantamab-based Combinations for Relapsed Multiple Myeloma","Retrospective Observational Study to Evaluate the Effectiveness and Safety of Belantamab Mafodotin-based Combinations (Belantamab Mafodotin, Bortezomib, Dexamethasone [BVd] or Belantamab Mafodotin, Pomalidomide, Dexamethasone [BPd]) Used as Compassionate Use in Patients With Multiple Myeloma in First or Second Relapse","GEM-BELACOMBOS","Inclusion Criteria:\n\n* Confirmed diagnosis of relapsed\u002Frefractory MM.\n* Having received at least one dose of a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions as treatment for a first or second relapse.\n* Patients ≥18 years of age at the start of treatment with the belantamab mafodotin combination (BVd or BPd) under compassionate use conditions.\n\nExclusion Criteria:\n\n* Any patient who has received a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions in fourth line of treatment or later will be excluded from the study.",{"count":77,"type":20},100,"OBSERVATIONAL","The goal of this retrospective observational study is to characterize multiple myeloma (MM) patients (by collecting demographics, disease characteristics and treatment history data) treated in first or second relapse with belantamab mafodotin combinations under compassionate use conditions.",[81],"Relapse Multiple Myeloma",[83],"belantamab mafodotin","NOT_YET_RECRUITING","2026-06-19",{"date":87,"type":36},"2026-06-24",{"date":89,"type":20},"2026-06-01",{"date":91,"type":20},"2027-12-31",{"name":42,"class":43},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":121,"locationsCount":122},"100631982","phase-2-oral-decitabine-plus-ivosidenib-as-first-line-for-olderunfit-adult-aml-patients-100631982","NCT07507760","Oral Decitabine Plus Ivosidenib as First Line for Older\u002FUnfit Adult AML Patients","A Phase II, Multicentre, Open Label Clinical Trial Evaluating the Efficacy and Safety of Oral Decitabine Plus Ivosidenib in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia Older Than 60 Years Old and\u002For Who Are Ineligible for Standard Induction Chemotherapy","DECISIVO","Inclusion Criteria:\n\n1. Morphological diagnosis of AML (WHO criteria 2022)\n2. Newly diagnosed AML.\n3. IDH1 R132 mutations (centrally assessed by PCR and NGS). A patient will be allowed to be included with local result after approval of the medical monitor.\n4. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2 if ≥ 60 years of age, or 0 to 3 if ≥ 18 to 60 years.\n5. Age ≥ 18 years with comorbidities contraindicating intensive chemotherapy; or age ≥ 60 years.\n\n   * ≥ 60 years of age;\n   * or ≥ 18 to 60 with at least one of the following co-morbidities:\n\n     * ECOG Performance Status of 2 or 3;\n     * Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 55% or chronic stable angina;\n     * DLCO ≤ 65% or FEV1 ≤ 65% or significant history of chronic pulmonary obstructive;\n     * Creatinine clearance ≥ 25 mL\u002Fmin to \\\u003C 50 ml\u002Fmin\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × ULN\n     * Non active\u002Fcontrolled prior neoplastic disease\n     * Any other patient´s comorbidity or disease condition that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the PETHEMA medical monitor before study enrolment (e.g, prior MDS or MPS, high-risk cytogenetics)\n6. Patients \\\u003C70 years, with favorable risk AML according to ELN will be included only if they are not candidates to standard treatment with intensive chemotherapy.\n7. Adequate renal function as demonstrated by a creatinine clearance ≥ 25 mL\u002Fmin (calculated by the Cockcroft Gault formula).\n8. Adequate liver function as demonstrated by: aspartate aminotransferase (AST) ≤ 5.0 × ULN, alanine aminotransferase (ALT) ≤ 5.0 × ULN, bilirubin ≤ 2.5 × ULN (unless considered to be due to leukemic disease, in which case it should be approved by the PETHEMA medical monitor).\n9. Subject has a white blood cell count \\\u003C 30 × 109\u002FL (Hydroxyurea is permitted to meet this criterion)\n10. Female subjects must be either postmenopausal OR permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) OR Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control. Female subjects of childbearing potential must have negative results for pregnancy tests performed along the study (screening and every three cycles). A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.\n11. Male subjects who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice the protocol specified contraception.\n12. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n\nExclusion Criteria:\n\n1. Subject has history of myeloproliferative neoplasm \\[MPN\\] with BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n2. Prior therapy for AML (except hydroxiurea).\n3. Genetic diagnosis of acute promyelocytic leukemia.\n4. Subject is known to be positive for HIV (HIV testing is not required.)\n5. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required).\n6. Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients that in the opinion of the investigator would adversely affect his\u002Fher participating in this study.\n7. Any severe uncontrolled systemic infection.\n8. Subject has a history of other malignancies within 1 year prior to study entry which is not controlled and\u002For requiring active therapy which may compromise the administration of IVO and oral decitabine.\n9. Creatinine clearance \\\u003C25 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n10. Inadequate liver function as demonstrated by AST or ALT \\> 5.0 × ULN, or bilirubin \\> 2.5 × ULN (unless considered to be due to leukemic disease, in which case it should be approved by the PETHEMA medical monitor)\n11. Subject has a white blood cell count \\> 30 × 109\u002FL that is not controlled using hydrea or 1 gr\u002Fsqm\u002Fday per 1 day of cytarabine.\n12. Contraindications for IVO or oral decitabine according to the SmPC.\n13. Patient has a heart rate-corrected QT interval using Fridericia's method QT for corrected heart rate (QTcF) ≥450 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (e.g., hypokalemia, family history of long QT interval syndrome). Patients with prolonged QTcF interval in the setting of bundle branch block may participate in the trial.",{"count":102,"type":20},50,[23],"The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who are older than 18 years old with defined comorbidities that make them not suitable for standard induction therapy. The main objectives of this clinical trial are:\n\n* Asses the Complete Remission (CR) and Complete Remission with incomplete marrow recovery (CRi) rates of this treatment.\n* Determine the incidence and severity of all adverse events (AEs).\n\nAll participants will receive oral ivosidenib and oral decitabine in treatment cycles of 28 days until disease progression, lack of clinical benefit or the end of the study. Patients who achieve CR\u002FCRi will be elegible to receive allogeneic stem cell transplantation.",[106],"Acute Myeloid Leukemia With Gene Mutations",[108,109,110,111,112,113,114],"AML","older adult","unfit","IDH1 R132 mutation","Decitabine","Ivosidenib","allogeneic stem cell transplant","2026-03-27",{"date":117,"type":36},"2026-04-02",{"date":119,"type":20},"2026-04",{"date":65,"type":20},{"name":42,"class":43},15,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100629770","phase-3-azacytidine-venetoclax-plus-minus-quizartinib-for-first-line-olderunfit-aml-patients-venp-a-qui-100629770","NCT07478991","Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older\u002FUnfit AML Patients (VENP-A-QUI)","A Randomized Phase III, Global, Multicentre, Open Label Clinical Trial Comparing Venetoclax Azacytidine and Quizartinib Versus Venetoclax and Azacytidine in Newly Diagnosed Acute Myeloid Leukemia Patients Unelegible for Standard Induction Chemotherapy","VENP-A-QUI","Inclusion Criteria:\n\n1. The subject must have confirmation of AML by 2022 WHO criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline based induction regimen due to age and\u002For comorbidities.\n2. Patients must be considered ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or co-morbidities defined by the following criteria:\n\n   * ≥ 75 years of age;\n   * or ≥ 18 to 75 years of age with at least one of the following co-morbidities:\n\n     * ECOG Performance Status of 2 or 3;\n     * Cardiac history of cardiac heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) \\>45% and ≤ 55% or chronic stable angina.\n     * DLCO ≤ 65% or FEV1 ≤ 65% and\u002For significant history of chronic pulmonary obstructive;\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 50 ml\u002Fmin (see Appendix 7);\n     * Moderate hepatic impairment with total bilirubin, SGPT or SGOT \\> 1.5 to ≤ 3.0 × ULN;\n     * Non active\u002Fcontrolled prior neoplastic disease;\n     * Any other patient´s comorbidity or disease condition that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Clinical Trial Coordinator before study enrollment (e.g, prior neoplastic disease, high-risk cytogenetics). All patients aged less than 60 years old must be reviewed and approved by Clinical Trial Coordinator before study enrollment.\n3. ECOG performance status ≤2 for patients \\>75 years, ≤3 for patients ≥ 60 to 75 years of age.\n4. Male subjects who are sexually active, must agree, from Study Day 1 through at least 120 days after the last dose of study drug, to practice the protocol specified contraception.\n5. Female subjects must be either postmenopausal for at least 1 year before screening OR permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) or Women of Childbearing Potential (WOCBP) must agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 7 months after the last dose of study drug (female and male condoms should not be used together), or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception). Female subjects of childbearing potential must have negative results for pregnancy test performed and must not be lactating and breastfeeding.\n6. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study specific procedures, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years old at screening.\n2. Subject has received prior treatment with hypomethylating agent, FLT3 or BCL2 inhibitors.\n3. Confirmed diagnosis of prior myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS\u002FMPNs including CMML, aCML, JMML and others. This exclusion criterion will not be applicable to patients with FLT3 or NPM1 mutations (as per technical sensitivity threshold of local and\u002For central laboratory), who can be enrolled.\n4. Genetic diagnosis of acute promyelocytic leukemia.\n5. Treated (excluding surgery or hormone-therapy) for another malignancy within 6 months before randomization or previously diagnosed with another malignancy and have any evidence of disease which may compromise the administration of investigational treatment schedule.\n6. Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial.\n7. Serum creatinine ≥ 2.5 mg\u002FdL or creatinine clearance \\\u003C 30 mL\u002Fmin.\n8. Bilirubin \\>1.5 times, SGPT or SGOT \\> 3 times the upper normal limit (unless it is attributable to AML activity).\n9. WBC \\>25 x 109\u002FL before randomization.\n10. Contraindications for Azacitidine, Quizartinib or Venetoclax (such as history of hypersensitivity to any excipients in Azacitidine, Quizartinib, or Venetoclax).\n11. Known central nervous system (CNS) active leukemia, including cerebrospinal fluid positive for AML blasts.\n12. Prior treatment with any investigational drug or device within 14 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational interventional procedures.\n13. Known uncontrolled or significant cardiovascular disease, including any of the following:\n\n    1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;\n    2. QTcF interval \\>450 msec;\n    3. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);\n    4. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;\n    5. History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);\n    6. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);\n    7. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;\n    8. History of New York Heart Association Class 3 or 4 heart failure;\n    9. Known history of LVEF ≤45%;\n    10. Complete left bundle branch block;\n    11. Severe aortic stenosis\n14. Prior therapy for AML (except hydroxyurea, or maximum 1 gram\u002Fsqm\u002Fday per 2 days of cytarabine allowed to control hyperleukocytosis during the screening period).\n15. Subject must not have consumed grapefruit, grapefruit products, Seville oranges (including marmalade-containing Seville oranges), or star fruit within 3 days before anticipated first dose of Venetoclax and must consent not to consume through the last dose of Venetoclax.\n16. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy at physician discretion.\n17. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C)\n18. Known history of human immunodeficiency virus (HIV).\n19. Uncorrected Grade 3 or 4 hypokalemia, hypomagnesemia or hypocalcemia (Subjects with Grade 1 or 2 electrolyte abnormalities can be enrolled while electrolytes are being corrected).\n20. Uncontrolled hypothyroidism.",{"count":132,"type":20},376,[57],"The goal of this clinical trial is to learn if Venetoclax+Azacytidine+Quizartinib works better than standard therapy (Venetoclax+Azacytdine) to treat naïve adult patients with acute myeloid leukemia (AML) who are not suitable for standard induction therapy due to age, co-morbidities or other risk factors. The main question it aims to answer is:\n\n\\- Does the combination of Venetoclax+Azacytidine+Quizartinib show more probability of overall survival than Venetoclax+Azacytdine?\n\nResearchers will compare Venetoclax+Azacytidine+Quizartinib to Venetoclax+Azacytdine to see if Venetoclax+Azacytidine+Quizartinib works better than Venetoclax+Azacytdine to treat AML.\n\nParticipants will be randomized to one of the two treatment arms in a 1:1 ratio, both of which will have treatment cycles of 28 days.",[136],"Acute Myeloid Leukemia, Adult",[108,138,139],"adult","old\u002Funfit","2026-03-13",{"date":142,"type":36},"2026-03-18",{"date":144,"type":20},"2026-03",{"date":146,"type":20},"2030-04",{"name":42,"class":43},51,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100627050","treatment-for-ph-negative-all-for-adults-up-to-65-years-100627050","NCT07443592","Treatment for Ph-negative ALL for Adults up to 65 Years","Protocol for the Treatment of BCR::ABL1-negative Acute Lymphoblastic Leukemia in Adults up to 65 Years","LAL-2025","Inclusion Criteria:\n\n* De novo ALL.\n* Age 18-65 years.\n* No prior treatment, except:\n\nUrgent leukapheresis, Urgent treatment of hyperleukocytosis with hydroxyurea, Urgent cranial irradiation (one dose) for CNS leukostasis, Urgent mediastinal irradiation for superior vena cava syndrome.\n\n* Adequate general condition (ECOG score 0-2), or \\>2 if due to ALL.\n* Negative pregnancy test for women of childbearing age.\n\nExclusion Criteria:\n\n* Age \\> 65 years.\n* ALL type L3 or with mature B phenotype (sIg+) or with the cytogenetic alterations characteristic of mature B-cell ALL (t(8;14), t(2;8), t(8;22)).\n* Ph-positive B-cell ALL (BCR::ABL1).\n* Lymphoid blast crisis of chronic myeloid leukemia.\n* Patients with a history of coronary artery disease, valvular heart disease, or hypertensive heart disease, which contraindicates the use of anthracyclines.\n* Patients with active chronic liver disease.\n* Patients with severe chronic respiratory failure.\n* Renal insufficiency not due to ALL.\n* Severe neurological disorders, not due to ALL, that contraindicate the use of these treatments (especially blinatumomab).\n* History of clinically significant pancreatitis, at the investigator's discretion (taking into account the date of the pancreatitis, its previous severity, and sequelae).\n* Pregnancy or breastfeeding.\n* Psychiatric or mental illness that prevents providing informed consent for sample submission or adequately participating in the study.\n* Impaired general health (ECOG scores 3 and 4) not attributable to ALL.",{"count":158,"type":20},330,[160],"NA","The goal of this trial is to provide a protocol for treatment for adults with Ph-negative acute lymphoblastic leukemia (ALL) and to learn if this provides higher probability of survival than the previous one. The main question is to know if the incorporation of blinatumomab for B-cell precursor ALL, substituting some chemotherapy blocks, offers better probability of survival than the previous trial, which did not use immunotherapy. In addition, T-cell precursor ALL participants will receive different treatment approaches depending on the stage of maturation of the tumor.",[163],"Acute Lymphoblastic Leukemia",[16,138,165,166,167,168,169],"Philadephia-negative","minimal residual disease","genetics","immunotherapy","transplantation","2026-02-25",{"date":172,"type":36},"2026-03-02",{"date":174,"type":20},"2026-03-06",{"date":176,"type":20},"2033-06-01",{"name":42,"class":43},95,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":5},"100596472","phase-2-efficacy-and-safety-of-anitocabtagene-autoleucel-in-participants-with-newly-diagnosed-multiple-myeloma-gem-anitofirst-100596472","NCT07045909","Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)","A Phase 2, Open-label, Multicenter Multi-cohort Study to Evaluate the Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma","GEM-AnitoFIRST","Inclusion Criteria:\n\n1. Newly diagnosed Multiple Myeloma according to the IMWG criteria published in 2014.\n\n   1. For cohort A, patients will ≤ 70 years of age.\n   2. For the cohorts B and C, patients will be ≤ 80 years of age.\n2. Measurable disease at screening per IMWG, defined as any of the following:\n\n   1. Serum M-protein level ≥ 1 g\u002FdL or urine M-protein level ≥ 200 mg\u002F24 hours; or\n   2. Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg\u002FdL and abnormal serum free light chain ratio.\n\n      * Note: Local laboratory results may be used to establish measurable disease at screening if the results are ≥ 125% of requirements.\n3. Only participants who are candidates to receive either D-VRd or Isa-VRd induction regimens, as determined by the investigator, should be considered for this study.\n4. Male or female aged 18 years or older and has capacity to give informed consent.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Adequate hematological function defined as the following:\n\n   * Hemoglobin count ≥ 7.5 g\u002FdL (without any red blood cell \\[RBC\\] transfusion within 7 days prior to the test result; use of recombinant human erythropoietin is permitted).\n   * Absolute neutrophil count (ANC) ≥ 500\u002FμL (without non-PEGylated myeloid growth factor support within 7 days or PEGylated myeloid growth factor support within 14 days prior to the test result).\n   * Platelet count ≥ 75,000\u002FμL (unless secondary to bone marrow or spleen involvement of MM, in which platelet count ≥ 50,000\u002FμL is permitted) without any platelet cell transfusion within 7 days prior to the test result. Bone marrow involvement by MM is demonstrated by bone marrow aspiration or biopsy. Spleen involvement by MM is demonstrated by splenomegaly.\n   * Absolute lymphocyte count (ALC) ≥ 100\u002FμL.\n   * PTT\u002FPT\u002FINR \\\u003C 1.5x upper limit of normal (ULN), unless on a stable dose of anticoagulant for a thromboembolic even (subjects with a history of thromboembolic stroke or history of Grade 2 or greater hemorrhage within 1 year are excluded.\n7. Adequate renal, hepatic, pulmonary, and cardiac function defined as the following:\n\n   * Estimated glomerular filtration rate (eGFR) (as estimated by Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation \\[Section 12.14\\]) ≥ 45 mL\u002Fmin.\n   * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.\n   * Total bilirubin ≤ 1.5 mg\u002FdL, except in participants with Gilbert's syndrome or documented MM liver or pancreatic involvement where ≤ 3 x ULN is permitted.\n   * Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion as determined by echocardiogram (ECHO). Multigated acquisition (MUGA) scan may be used if an ECHO is not available at the site.\n   * No evidence of Grade 2 or higher (per National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5.0) pleural effusion or ascites (participants with Grade 1 pleural effusion or ascites are eligible).\n   * Baseline oxygen saturation \\>92% on room air.\n8. Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential; refer to Section 12.2).\n9. Willing to comply with and able to tolerate study procedures, including consent to participate in separate Long-term Safety Follow-up lasting up to 15 years per authorities´ guidance.\n\nExclusion Criteria:\n\n1. Active or prior history of central nervous system (CNS) or meningeal involvement of MM.\n2. Cardiac atrial or cardiac ventricular MM involvement.\n3. Diagnosis of primary amyloidosis (AL), monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia (PCL), active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or Waldenstrom's macroglobulinemia at the time of screening.\n4. Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted. Allowed malignancy exceptions are:\n\n   1. Localized skin cancer (melanoma and nonmelanoma) that has been completely resected and considered curative within the last 24 months is eligible.\n   2. Cervix carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible.\n   3. Bladder carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible.\n   4. Breast carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible. Hormonal therapy after curative-intent treatment is permitted.\n   5. Prostate cancer that is low grade and localized (Grade Group 1, has not spread to nearby lymph nodes \\[N0\\] or metastasized \\[M0\\]) within the last 24 months is eligible, including cases under surveillance only as part of standard of care. Androgen deprivation therapy is permitted.\n   6. Localized renal cell carcinoma (≤ Stage 2) that has been completely resected and considered curative within the last 24 months is eligible.\n   7. Localized (Stage 1) colorectal cancer that has been completely resected and considered curative (without need for adjuvant chemotherapy) within the last 24 months is eligible.\n5. Any prior systemic anti-myeloma treatment (including BCMA-directed treatment) and\u002For radiotherapy before enrollment. Palliative radiation and corticosteroids (up to cumulative dose of 160mg prednisone or equivalent, and not requiring ongoing therapy) prior to enrollment are permitted. Participants must have recovered from all radiation-related toxicities. Patients with radiation-induced lung injury (RILI, radiation pneumonitis) during screening are excluded.\n6. Prior allogeneic stem cell transplant (allo-SCT) (even if for another malignancy)\n7. Live vaccine ≤ 4 weeks before enrollment and\u002For anticipating needing the vaccine during study period.\n8. Presence or suspicion of fungal, bacterial, viral, or other infection that is systemic uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if the participant is responding to active treatment and satisfies the criteria of being afebrile (i.e., temperature \\\u003C 38°C) for at least 24 hours prior to the investigator confirming the participant's eligibility.\n9. Acute or chronic active hepatitis A, B, or C infection. Participants with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines or applicable country guidelines.\n10. Human immunodeficiency virus (HIV)-seropositive.\n11. Participants with history or presence of chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal will not be permitted to receive anti-CD38 monoclonal antibody in combination with VRd therapy; Note: FEV1 testing is required for participants who are planned\n12. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months before enrollment.\n\n    a. History or presence of intracranial or CNS disorder, such as hemorrhage, dementia, altered mental status, cerebellar disease, or any autoimmune disease with CNS involvement, PRES, or cerebral edema with confirmed structural defects by appropriate imaging. History of stroke or transient ischemic attack within 12 months before enrollment, or seizure disorders requiring active anticonvulsive medication. Patient with history of neurodegenerative disease (e.g., Parkinson's or Alzheimer's disease) must be excluded.\n13. Peripheral neuropathy of Grade 3 or higher (per CTCAE v5.0; participants with Grade 2 peripheral neuropathy are eligible).\n14. History of solitary plasmacytoma\n15. History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in or requiring systemic immunosuppression or systemic disease-modifying agents within 2 years.\n16. History of concomitant genetic syndrome associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome.\n17. History of DVT or PE within 6 months before enrollment. Anticoagulants (e.g., warfarin, low-molecular weight heparin, Factor Xa inhibitors) are allowed if DVT\u002FPE occurred \\> 6 months before enrollment, and if the participant is on a stable maintenance dose.\n18. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G\u002FJ tube, or pleural\u002Fperitoneal\u002Fpericardial catheter). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.\n19. Major surgery within 28 days before enrollment, or planned surgery required during study participation.\n20. Any medical, neurologic or psychiatric condition that in the investigator's opinion is likely to interfere with study procedures including assessment of safety or efficacy of the study treatment.\n21. Females who are pregnant or breastfeeding (due to the potentially dangerous effects of the lymphodepleting chemotherapy or induction regimen on the fetus or infant).\n22. Participants of both sexes who are not willing to practice highly effective birth control from the time of consent through 12 months following lymphodepleting chemotherapy administration, 12 months after the completion of anitocabtagene autoleucel, 5 months after the last dose of isatuximab, 3 months after the last dose of daratumumab, bortezomib, or 28 days after the last dose of lenalidomide, whichever is longer (refer to Section 12.2). Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential. Participants of both sexes must also comply with any relevant REMS or aRMMs as part of an RMP. Additional information is in Section 6.3.1.\n23. As per the investigator's judgment, the participant is unlikely to complete all protocol required study visits or procedures, including follow-up visits, or comply with or tolerate the study requirements for participation (e.g., participants who are at a risk for a thromboembolic event and are not willing to take venous thromboembolism prophylaxis should be excluded).\n24. Contraindication to fludarabine or cyclophosphamide.\n25. History of allergy or hypersensitivity to any study agent or study drug components. Participants with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.","80 Years",{"count":189,"type":20},30,[23],"The goal of this clinical trial is to learn if anitocabtagene autoleucel following induction therapy works to treat adult participants with newly diagnosed multiple myeloma. The main objectives of this clinical trial are:\n\n* To determine the incidence and severity of all adverse events (AEs).\n* To determine the proportion of patients achieving undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10 to -5) at 12 months (+\u002F- 3 months) after enrollment.\n\nParticipants will receive induction therapy with a quadruplet regimen including a proteasome inhibitor (Bortezomib \\[V\\]), immunomodulatory drug (Lenalidomide \\[R\\]), dexamethasone \\[d\\] and anti-CD38 monoclonal antibody (Daratumumab \\[D\\] or Isatuximab \\[Isa\\]) followed by anitocabtagene autoleucel. Participants in Cohorts A and B will receive lenalidomide maintenance therapy following infusion with anitocabtagene autoleucel.",[193,194],"De Novo Multiple Myeloma","Anitocabtagene Autoleucel","2025-07-31",{"date":197,"type":36},"2025-08-01",{"date":199,"type":36},"2025-06-30",{"date":201,"type":20},"2030-03-31",{"name":42,"class":43},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},"100560206","phase-2-ciltacabtagene-autoleucel-in-high-risk-smoldering-multiple-myeloma-100560206","NCT06574126","Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma","Phase II Open-Label, Single Arm, Multicenter Study of Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma (GEM-CAR-HiRiSMM)","CAR-HiRiSMM","Inclusion Criteria:\n\n\\- Be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.\n\n\\- High-risk SMM defined as having 1 of the following 2 criteria: i) High-risk per \"Mayo 20-2-20\" criteria defined as presence of any ≥2 of the following:\n\n1. Serum M-protein ≥2 gm\u002FdL\n2. Involved to uninvolved FLC ratio ≥20\n3. BMPC % ≥20% to \\\u003C40% OR ii) Presence of ≥95% of BMPC with an aberrant phenotype within the BMPC compartment and immunoparesis present defined as a reduction of at least 25% below the lower normal limit for ≥1 uninvolved immunoglobulin isotype (only IgG, IgA and IgM will be considered).\n\n   \\- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1.\n\n   \\- Have an estimated glomerular filtration rate (eGFR), based on the Modified Diet in Renal Disease (MDRD) 4-variable formula or 24-hour urine collection of ≥40 mL\u002Fmin during the screening period.\n\n   \\- Laboratory values obtained \\\u003C21 days prior to Screening: i) Total bilirubin ≤2.0 mg\u002FdL ii) Aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) iii) Alanine transaminase (ALT) ≤3 x ULN\n\n   \\- Hemoglobin ≥8.0 g\u002FdL (≥5 mmol\u002FL) (without prior red blood cell \\[RBC\\] transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted). For subjects who meet the inclusion criteria at screening, transfusion of RBCs is permitted after screening as needed to maintain a hemoglobin level ≥8.0 g\u002FdL.\n\n   \\- Neutrophils ≥1.0 × 109\u002FL (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test)\n\n   \\- Platelets ≥75 × 109\u002FL (must be without transfusion support in the 7 days prior to the laboratory test)\n\n   \\- Lymphocyte count ≥0.3\\*109\u002FL\n\n   \\- Participants should be seronegative for human immunodeficiency virus (HIV) or have controlled disease if seropositive.\n\n   \\- A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.\n\n   \\- A female participant must be either of the following: i) Not of childbearing potential ii) Of childbearing potential and practicing at least 1 highly effective method of contraception throughout the study and through 6 months after the last dose of study treatment. If a female participant becomes of childbearing potential after the start of the study, the female participant must comply with ii).\n\n   \\- A female participant using oral contraceptives should use an additional barrier contraceptive method.\n\n   \\- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the cilta-cel infusion. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility.\n   * A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 1 year after receiving the cilta-cel infusion. If the male participant's partner is a female of childbearing potential, the male participant must use condoms (with or without spermicide) and the female partner of the male participant must also be practicing a highly effective method of contraception. A male participant who is vasectomized must still use a condom (with or without spermicide), but the partner is not required to use contraception.\n   * A male participant must agree not to donate sperm for the purposes of reproduction during the study and for 1 year after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anti-cancer treatments may impair fertility.\n   * A male participant must agree not to plan to father a child while enrolled in this study or within 1 year after the last dose of study treatment.\n   * Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n   * An additional ICF will be collected to get participants authorization to collect the necessary samples for performing the Biological studies indicated in this protocol.\n   * Be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\n   Exclusion Criteria:\n\n   \\- History of uncontrolled illness, including but not limited to MGUS, standard risk smoldering myeloma, active myeloma by current IMWG definition, light chain amyloidosis with organ involvement or patients with extramedullary disease.\n\n   \\- Non-muscle-invasive bladder cancer treated within the last 24 months that is considered completely cured.\n\n   \\- Skin cancer (nonmelanoma or melanoma) treated within the last 24 months that is considered completely cured.\n   * Noninvasive cervical cancer treated within the last 24 months that is considered completely cured.\n   * Localized prostate cancer (N0M0):\n\n     i) with a Gleason score ≤6, treated within the last 24 months or untreated and under surveillance.\n\n   ii) with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n\n   iii) history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence).\n\n   \\- Adequately treated lobular carcinoma in situ or ductal carcinoma in situ.\n\n   \\- History of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence.\n\n   \\- Known allergies, hypersensitivity, or intolerance to cilta-cel or its excipients.\n\n   \\- Participant had major surgery or had significant traumatic injury ≤14 days prior to Cycle1Day1.\n   * If any of the following exist at screening, participant will be excluded because this trial involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown:\n\n     i) Pregnant women ii) Nursing women iii) Men or women of childbearing potential who are unwilling to employ adequate contraception\n   * Other comorbidity which would interfere with subject's ability to participate in trial, eg, uncontrolled infection, uncompensated heart, or lung disease.\n   * Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n   * History of neurodegenerative disease (eg, Parkinson or stroke within 6 months).\n   * Medical history of treatment for another malignancy \\\u003C2 years before trial enrollment, other concurrent chemotherapy, or any ancillary therapy considered investigational. Note: Bisphosphonates are considered supportive care rather than therapy and are thus allowed while on protocol treatment.\n   * Known seropositive for or active viral infection with HIV, HBV, hepatitis C virus (HCV), or SARS-CoV-2 (Coronavirus Disease 2019 \\[COVID-19\\]).\n\n     i) Participants who are positive for SARS-COV-2 antibody, HIV1 and 2 antibody, hepatitis B core antibody (HBc), or hepatitis B surface antigen (HBsAg) must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.\n\n   ii) Participants who are positive for HIV1 or 2 infections, with undetectable viral load and on stable antiretrovirals, will not be excluded.\n\n   iii) Participants with past HCV infection need at least 12 months of sustained virologic response and be negative for RNA to enter.\n\n   iv) Patients with a high-risk of HBV reactivation (eg, negative for HBV antigen but positive for chronic HBV, with or without anti-serum HBV) must be monitored with DNA and ALT\u002FAST).\n\n   \\- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n\n   NOTE: Investigators must ensure that all study enrollment criteria have been met at screening. If a participant's clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study intervention is given such that the participant no longer meets all eligibility criteria, then the participant must be excluded from participation in the study.",{"count":212,"type":20},20,[23],"This is an open-label, single arm, multicenter, interventional study with Dara-VRD followed by cilta-cel in high-risk smoldering multiple myeloma (SMM) patients.\n\nThe primary objectives of this trial, related with efficafy and safety of the treatment, are i) to evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease (MRD) at 6 months, 12 months, and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat (ITT) population; ii) to annotate frequency and severity of adverse events (AE) and serious adverse events (SAE), as well as data from laboratory tests aslo related with safety such as Immunoglobulin (Ig) G levels, complete blood count (CBC) cytopenia adn T-cell populations. Secondary objectives are related with response to therapy and will measure different categories of response and survival.",[216],"High Risk Smoldering Multiple Myeloma",[218,219],"Smoldering Multiple Myoloma","CAR T-cells","2024-10-23",{"date":222,"type":36},"2024-10-26",{"date":224,"type":36},"2024-09-30",{"date":226,"type":20},"2032-09-30",{"name":42,"class":43},1,{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":4},"100529586","treatment-protocol-for-newky-diagnosed-adult-ph-positive-all-100529586","NCT06175702","Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL","Treatment Protocol for Newky Diagnosed Adult Ph-Chromosome Positive (BCR::ABL1) Acute Lymphoblastic Leukemia (LALPh2022)","LALPh2022","Inclusion Criteria:\n\n1. Patients with de novo avute lymphoblastic leukeima (ALL) Philadelphia chromosome-positive (BCR::ABL1) aged ≥18 years.\n2. CML blast crisis will be included. These patients will always receive transplantation, regardless of the molecular response or the genetic risk, following the recommendations of the SEHH CML group (Chronic Myleoid Leukemia Group from the Spanish Society of Hematology).\n3. Performance status 0-2; patients with performance status\\>2 attributable to ALL can be included.\n4. Patients without functional alteration of organs; liver function: total bilirubin, GOT, GPT, GGT and alkaline phosphatase less than 3 times the upper limit of the normal range of the laboratory; renal function: serum creatinine \\\u003C2 mg\u002Fdl or creatinine clearance \\> 30 ml\u002Fmin (except altered renal function attributable to ALL); normal heart function: EF ventricular \\> 50%; absence of severe chronic respiratory disease. In case that the alterations are secondary to the disease, it is at the discretion of the physician to determine if the patient can be included in the study.\n\nExclusion Criteria:\n\n1. Any other subtype of ALL.\n2. Patients with chronic liver disease.\n3. Patients with chronic respiratory failure.\n4. Renal failure not due to ALL.\n5. Lipase and amylase\\>1.5× ULN.\n6. Patients with positive HIV serology.\n7. Serious neurological alterations not due to ALL.\n8. Serious general condition condition (grades 3 or 4 on the WHO scale) not attributable to ALL.\n9. Pregnant or breastfeeding women.\n10. Impaired cardiac function (defined by an ejection fraction less than 50%), any clinically significant active or uncontrolled cardiovascular condition, uncontrolled hypertension, arrhythmias, ischemic cardiovascular or neurological events, deep vein thrombosis, pulmonary thromboembolism, history of acute pancreatitis in the year before diagnosis of ALL or history of chronic pancreatitis and triglycerides \\>450 mg\u002FdL.",{"count":238,"type":20},150,"The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved combinations of chemotherapy and tyrosine kinase inhibitor (TKI).\n\nEfficay refers to the rate of Complete Molecular Response (BCR::ABL1\u002FABL1 ratio 0.01%) in eah treatment arm. Safety refers to measurement of i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests), ii) incidence and degree of cytopenias and iii) incidence and degree of infections.\n\nLow-dose chemotherapy will be given together with the TKI imatinib to patients of all ages as induction to remission phase.\n\nConsolidation treatment will continue with low-dose chemotherapy with imatinib if the patient fullfills both criteria: to show a measurable residual disease (MRD) value lower than 0,01% at 3 month of therapy, and not showing IKZF1plus genetics Those patients have any of these 2 conditions will be considered high-risk patients and will recieve consolidation treatment intensification with low-dose chemotherapy plus ponatinib as TKI and allogeneic stem cell transplantation (allo SCT). The remaining patients (standard-risk) will receive maintenance chemotherapy together with imatinib or ponatinib and will not be submitted to alloSCT.",[241,242,243],"Lymphoblastic Leukemia","Philadelphia-Positive ALL","Adult ALL",[163,245,246],"Philadelphia (BCR::ABL1) positive","Adults","2023-12-15",{"date":249,"type":36},"2023-12-19",{"date":251,"type":20},"2023-12-25",{"date":253,"type":20},"2030-12-25",{"name":42,"class":43},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":21,"phases":265,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100376316","treatment-of-breakpoint-cluster-region-abelson-bcr-abl-negative-all-in-adults-100376316","NCT04179929","Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults","Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics","Inclusion Criteria:\n\n* Patients 18-60 yr with de novo Ph-neg ALL\n* Eastern Cooperative Oncology Group (ECOG) 0-2 (or \\>2 if due to ALL)\n* Informed consent\n\nExclusion Criteria:\n\n* Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL of ambiguous lineage\n* ECOG \\>2 not due to ALL\n* Impaired cardiac, respiratory, hepatic or renal function not due to ALL\n* Pregnancy\n* HIV positivity\n* Severe psychiatric disease\n* Negative to sign informed consent.","60 Years",{"count":264,"type":20},300,[160],"After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline.",[163],[16,138,269,166,169],"Ph-negative","2022-02-17",{"date":272,"type":36},"2022-02-18",{"date":274,"type":36},"2019-11-25",{"date":276,"type":20},"2027-02",{"name":42,"class":43},108,""]