[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chemotherapy-induced-thrombocytopenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chemotherapy-induced-thrombocytopenia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,71,95,123,153,191,214,235,255,271],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100638121","phase-2-romiplostim-n01-plus-atra-for-persistent-isolated-chemotherapy-induced-thrombocytopenia-after-complete-remission-of-gynecologic-breast-or-lung-solid-tumors-100638121",false,"NCT07586826","Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors","A Prospective, Randomized, Open-Label, Controlled Study of Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia in Patients With Complete Remission of Gynecologic, Breast, or Lung Solid Tumors","N01-A-PICIT-GT","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Prior diagnosis of a selected gynecologic, breast, or lung solid tumor, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer. Other eligible tumor types may include endometrial cancer, cervical cancer, fallopian tube cancer, primary peritoneal cancer, and other lung cancers, if clinically appropriate and if all other eligibility criteria are met.\n3. Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 weeks before enrollment, no evidence of recurrence or progression by specialist assessment, and no current need for additional tumor-directed therapy.\n4. Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \\\u003C30 x 10\\^9\u002FL on two peripheral blood tests at least 7 days apart; or platelet count slightly higher than 30 x 10\\^9\u002FL with dependence on platelet transfusion to maintain a safe platelet level.\n5. Thrombocytopenia has persisted since the last chemotherapy treatment without a clear trend of spontaneous recovery.\n6. Red blood cell count and neutrophil count are generally preserved, without clinically significant anemia or neutropenia.\n7. Bone marrow assessment performed within 1 year after tumor diagnosis and chemotherapy shows no tumor cell infiltration; megakaryocyte count is normal or increased, with or without maturation impairment.\n8. No hepatosplenomegaly, portal hypertension, or other evidence suggesting abnormal platelet redistribution as the main cause of thrombocytopenia.\n9. Prior treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT without response, defined as failure of platelet count to rise to a safe level or to at least 2 times baseline after at least 2 weeks of standard-dose treatment.\n10. No prior use of Romiplostim N01.\n11. Other platelet-raising medications have been discontinued before enrollment. No washout period is required for prior thrombopoietin receptor agonists; other investigational drugs or off-label treatments must be discontinued for at least 1 month before enrollment.\n12. Ability to understand and sign the informed consent form and willingness to comply with study visits and procedures.\n13. Participants of reproductive potential must agree to use effective contraception during study treatment. Female participants of childbearing potential must have a negative pregnancy test before enrollment.\n\nExclusion Criteria:\n\n1. Other hematologic diseases that may affect hematopoiesis or cause thrombocytopenia, including but not limited to aplastic anemia, myelodysplastic syndrome, leukemia or other hematologic malignancies, or a clear history of primary immune thrombocytopenia.\n2. Active recurrence or progression of the underlying tumor, or evidence of bone marrow metastasis or tumor cell infiltration on bone marrow examination.\n3. Uncontrolled chronic viral infection, including hepatitis B, hepatitis C, or HIV infection, or active severe infection at screening or within 4 weeks before screening.\n4. Severe cardiac, hepatic, renal, or other organ dysfunction, or any serious organic disease that would make the participant unable to tolerate study treatment.\n5. Pregnancy or breastfeeding.\n6. Known severe hypersensitivity to Romiplostim, Romiplostim N01, ATRA, or any component of the study drugs.\n7. Prior Romiplostim treatment associated with severe adverse reactions or lack of efficacy.\n8. Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological condition that prevents understanding of the study procedures, or any other condition that, in the investigator's judgment, may increase study risk or interfere with interpretation of study results.","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of selected gynecologic, breast, or lung solid tumors, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, and breast cancer.\n\nEligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count \\>50 x 10\\^9\u002FL in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet count changes, platelet transfusion requirements, bleeding events, and safety.",[27,28,29,30,31,32,33,34,35,36],"Persistent Isolated Chemotherapy-Induced Thrombocytopenia","Chemotherapy-Induced Thrombocytopenia","Gynecologic Cancers","Ovarian Cancer","Breast Cancer","Lung Cancer","Non-Small Cell Lung Cancer","Cervical Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer",[38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,36,35],"PICIT","Persistent isolated chemotherapy-induced thrombocytopenia","CIT","Chemotherapy-induced thrombocytopenia","Romiplostim N01","ATRA","All-trans retinoic acid","Tretinoin","Thrombopoietin receptor agonist","Gynecologic cancer","Ovarian cancer","Breast cancer","Lung cancer","NSCLC","Non-small cell lung cancer","Endometrial cancer","Cervical cancer","Complete remission","Platelet response","Thrombocytopenia","RECRUITING","2026-05-08",{"date":61,"type":62},"2026-05-14","ACTUAL",{"date":64,"type":62},"2025-12-22",{"date":66,"type":21},"2027-12-31",{"name":68,"class":69},"Peking University People's Hospital","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":94,"locationsCount":70},"100637558","phase-2-romiplostim-n01-plus-atra-for-persistent-isolated-chemotherapy-induced-thrombocytopenia-after-complete-remission-of-gastrointestinal-solid-tumors-100637558","NCT07586813","Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors","A Prospective, Randomized, Open-Label, Controlled Study of Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia in Patients With Complete Remission of Gastrointestinal Solid Tumors","N01-A-PICIT-GI","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Prior diagnosis of a gastrointestinal\u002Fdigestive system solid tumor, including but not limited to gastrointestinal tract, pancreatic, or colorectal cancer.\n3. Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 weeks before enrollment, no evidence of recurrence or progression by specialist assessment, and no current need for additional tumor-directed therapy.\n4. Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \\\u003C30 x 10\\^9\u002FL on two peripheral blood tests at least 7 days apart; or platelet count slightly higher than 30 x 10\\^9\u002FL with dependence on platelet transfusion to maintain a safe platelet level.\n5. Thrombocytopenia has persisted since the last chemotherapy treatment without a clear trend of spontaneous recovery.\n6. Red blood cell count and neutrophil count are generally preserved, without clinically significant anemia or neutropenia.\n7. Bone marrow assessment performed within 1 year after tumor diagnosis and chemotherapy shows no tumor cell infiltration; megakaryocyte count is normal or increased, with or without maturation impairment.\n8. No hepatosplenomegaly, portal hypertension, or other evidence suggesting abnormal platelet redistribution as the main cause of thrombocytopenia.\n9. Prior treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT without response, defined as failure of platelet count to rise to a safe level or to at least 2 times baseline after at least 2 weeks of standard-dose treatment.\n10. No prior use of Romiplostim N01.\n11. Other platelet-raising medications have been discontinued before enrollment. No washout period is required for prior thrombopoietin receptor agonists; other investigational drugs or off-label treatments must be discontinued for at least 1 month before enrollment.\n12. Ability to understand and sign the informed consent form and willingness to comply with study visits and procedures.\n13. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during study treatment.\n\nExclusion Criteria:\n\n1. Other hematologic diseases that may affect hematopoiesis or cause thrombocytopenia, including but not limited to aplastic anemia, myelodysplastic syndrome, leukemia or other hematologic malignancies, or a clear history of primary immune thrombocytopenia.\n2. Active recurrence or progression of the underlying tumor, or evidence of bone marrow metastasis or tumor cell infiltration on bone marrow examination.\n3. Uncontrolled chronic viral infection, including hepatitis B, hepatitis C, or HIV infection, or active severe infection at screening or within 4 weeks before screening.\n4. Severe cardiac, hepatic, renal, or other organ dysfunction, or any serious organic disease that would make the participant unable to tolerate study treatment.\n5. Pregnancy or breastfeeding.\n6. Known severe hypersensitivity to Romiplostim, Romiplostim N01, ATRA, or any component of the study drugs.\n7. Prior Romiplostim treatment associated with severe adverse reactions or lack of efficacy.\n8. Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological condition that prevents understanding of the study procedures, or any other condition that, in the investigator's judgment, may increase study risk or interfere with interpretation of study results.",{"count":20,"type":21},[24],"This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of gastrointestinal\u002Fdigestive system solid tumors, including but not limited to gastrointestinal tract, pancreatic, and colorectal cancers.\n\nEligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count \\>50 x 10\\^9\u002FL in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet count changes, platelet transfusion requirements, bleeding events, and safety.",[27,28,83,84,85],"Gastrointestinal Neoplasms","Pancreatic Cancer","Colorectal Cancer",[38,39,40,41,42,43,44,45,46,87,88,89,90,55,56,57],"Gastrointestinal solid tumor","Digestive system cancer","Pancreatic cancer","Colorectal cancer",{"date":61,"type":62},{"date":64,"type":62},{"date":66,"type":21},{"name":68,"class":69},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":70},"100596318","phase-2-romiplostim-n01-for-chemotherapy-induced-thrombocytopenia-in-pediatric-cancer-patients-100596318","NCT07043894","Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients","A Prospective, Multicenter Study on the Efficacy and Safety of Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia (CIT) in Children, Adolescents, and Young Adults (CAYA) With Hematological and Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent.\n2. Aged 6-24 years, any gender.\n3. ECOG performance status 0-2.\n4. Histologically\u002Fcytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent.\n5. Patients with potential curative opportunity eligible for standard therapy.\n6. Chemotherapy-induced thrombocytopenia (platelets \\\u003C75×10⁹\u002FL).\n7. Anticipated survival ≥8 months.\n8. Planned ≥2 additional chemotherapy cycles (21-\u002F28-day cycles).\n9. Laboratory parameters meeting:\n\n   * Renal function: Cr ≤1.5×ULN; Ccr ≥55 mL\u002Fmin.\n   * Hepatic function:\n\n     * Total bilirubin ≤1.5×ULN; ALT\u002FAST ≤3×ULN;\n     * For liver metastasis\u002Fcholangiocarcinoma: bilirubin ≤3×ULN, transaminases ≤5×ULN.\n10. No participation in other drug trials within 4 weeks.\n11. Good compliance with efficacy\u002Fsafety follow-up per protocol.\n12. Absence of severe complications (e.g., active GI bleeding\u002Fperforation, jaundice, obstruction, non-cancer fever \\>38°C).\n13. Ability to comprehend and sign informed consent.\n\nExclusion Criteria:\n\n1. Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc.\n2. Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage).\n3. Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating).\n4. Refractory cytopenias:\n\n   * Hemoglobin \\\u003C50 g\u002FL despite RBC\u002FEPO;\n   * ANC \\\u003C1.0×10⁹\u002FL despite G-CSF.\n5. Pelvic\u002Fspinal\u002Flarge-field radiotherapy within 3 months.\n6. Arterial\u002Fvenous thrombosis within 3 months.\n7. Severe cardiovascular disease (NYHA Class III-IV, arrhythmia with thromboembolic risk, post-CABG\u002Fstent) within 6 months.\n8. Use of rhTPO, rhIL-11, or TPO-RAs (eltrombopag\u002Favatrombopag\u002Fhetrombopag) within 2 weeks.\n9. Investigator-assessed risks compromising safety\u002Fefficacy evaluation.","6 Years","24 Years",{"count":105,"type":21},50,[24],"The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents\u002Fyoung adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are:\n\n* What proportion of participants achieve platelet count recovery (≥100×10⁹\u002FL or an increase of ≥30×10⁹\u002FL from baseline) within 3 weeks of romiplostim N01 treatment?\n* What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag).\n\nParticipants will:\n\n* Receive weekly subcutaneous injections of romiplostim N01 (starting dose: 2 µg\u002Fkg).\n* Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg\u002Fkg if platelets \\\u003C99×10⁹\u002FL, maximum dose 10 µg\u002Fkg, stop when target recovery is met).\n* Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.",[109,110,111,112,113],"Solid Tumors","Hematological Tumor","Children","Adolescent","Chemotherapy Induced Thrombocytopenia","2026-05-06",{"date":116,"type":62},"2026-05-07",{"date":118,"type":62},"2025-12-25",{"date":120,"type":21},"2026-09-01",{"name":122,"class":69},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":130,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100596652","early-phase-1-single-arm-romiplostim-to-prevent-cit-100596652","NCT07048249","Single Arm Romiplostim to Prevent CIT","Single Arm Evaluation of Romiplostim to Prevent Chemotherapy Induced Thrombocytopenia in Patients With Ewing Sarcoma","Inclusion Criteria:\n\n* Age: Patients must be \\>1 year old at the time of study consent.\n* Diagnosis: Patients with a new diagnosis of Ewing sarcoma treated with interval-compressed chemotherapy as per AEWS0031, AEWS1221, or AEWS1031.\n* Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n* Marrow disease: Patients with metastatic Ewing sarcoma to the bone marrow are not eligible. Marrow staging is not required for this study but should be performed if clinically indicated.\n* Concomitant therapy, cancer directed: Patients receiving whole lung radiation, \\>50% of pelvic irradiation, other substantial bone marrow radiation (i.e. ≥ 50% of vertebral marrow space), or patients undergoing pneumonectomy as a component of local control before cycle 14, are not eligible. These therapies are not an exclusion if instituted during or after cycle 14.\n* Concomitant therapy, non-cancer directed:\n\n  * Patients requiring hematopoietic stem cell rescue are not eligible.\n  * Previous use of romiplostim, eltrombopag or any other platelet-producing agent is not allowed.\n  * Previous therapy for immune thrombocytopenia and related conditions, including rituximab, mycophenolic acid, protracted systemic steroids, and\u002For IVIG, is prohibited.\n  * Treatment with erythropoietin-stimulating agents is prohibited.\n  * Patients receiving another investigational drug are not eligible.\n  * Patients who are receiving prophylactic dosing of heparin (i.e. enoxaparin) or oral anticoagulants (i.e. rivaroxaban) for thrombosis prevention may be considered for enrollment but will be excluded from secondary aim 'a' analysis (efficacy measured as the median platelet count and transfusion dependency) given shift in transfusion thresholds.\n* Concurrent Illnesses: Patients with a history of or current diagnosis of bone marrow failure, hematologic malignancy, pro-thrombotic condition, or platelet disorder (including immune or heparin induced thrombocytopenia) are not eligible.\n* Patients who in the opinion of the investigator may not be able to comply with the study (including safety monitoring requirements of the study) are not eligible.","1 Year",{"count":132,"type":21},26,[134],"EARLY_PHASE1","The goal of this clinical trial is to to assess the efficacy of romiplostim as a supportive care measure in patients with a new diagnosis of Ewing sarcoma receiving interval-compressed chemotherapy. The main questions it aims to answer are:\n\n1. To demonstrate the efficacy of romiplostim in patients with newly diagnosed Ewing sarcoma, measured specifically as the rate of CIT, defined as a failure to achieve platelet recovery (≥ 75,000\u002FµL post nadir, without transfusion, or a platelet count sufficient to resume chemotherapy per provider and institutional standard) within 7 days of planned chemotherapy cycle start, measured during the continuation phase (cycle 7 to end of cycle 13 or 16, per AEWS0031\u002FAEWS1221, or AEWS1031 respectively) of interval-compressed chemotherapy (every 2 week vincristine\u002Fcyclophosphamide +\u002F- doxorubicin and ifosfamide\u002Fetoposide chemotherapy) as compared to published institutional historical control rate.\n2. To determine the safety of incorporation of romiplostim supportive care when given concurrently with Ewing sarcoma therapy.\n3. To determine the feasibility of incorporation of romiplostim supportive care into upfront Ewing sarcoma regimens.",[137,113],"Ewings Sarcoma",[139,140,141,40,142],"romiplostim","ewing sarcoma","chemotherapy induced thrombocytopenia","NPLATE","2026-03-16",{"date":145,"type":62},"2026-03-18",{"date":147,"type":62},"2024-01-26",{"date":149,"type":21},"2028-01-01",{"name":151,"class":69},"Children's Hospital Medical Center, Cincinnati",2,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":170,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100578269","home-monitoring-of-complete-blood-count-performed-by-patients---a-pilot-study-on-the-implementation-process-in-south-baltic-countries-100578269","NCT06809101","Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.","AMBeR eBlood","Inclusion Criteria:\n\n* legally competent patients\n* aged 18 or older\n* diagnosed with cancer (ICD-10: C00\\* - C97\\*)\n* enrolled at the Department of Oncology\u002FHematology for outpatients\n* participants who are willing and able to give informed consent for participation in the study\n* participants should receive chemotherapy in Daily Chemotherapy Unit and be within 4 weeks of chemotherapy initiation, and the expected duration of chemotherapy should be at least 12 weeks from inclusion\n\nExclusion Criteria:\n\n* inability to give informed consent due to mental capacity or language barrier\n* patient unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result\n* known bleeding disorder\n* bad circulation preventing the patient from getting enough blood drops to perform the test",{"count":161,"type":21},265,"OBSERVATIONAL","Introduction:\n\nThe number of diagnosed cancers is systematically increasing every year. Cancer patients need to undergo regular blood tests to monitor safety and eligibility for treatment. In case of poor blood results, the chemotherapy session must be omitted. For patients living far from the center, this means unnecessary travel with involvement of helpers, additional costs, increased potential of hospital acquired infections, and frustration associated with missed opportunity for treatment.\n\nAims:\n\nThe primary aim of this study is to gain knowledge about successful implementation of remote, home monitoring of complete blood count to cancer patients during and after systemic treatment for cancer. The secondary aim of the AMBeR collective study protocol is to pilot new technology, gain more context around future investigations and verify costs and changes in patient treatment pathways.\n\nMethodology:\n\nThe investigators will test implementation of home blood monitoring in three South Baltic Countries (DK, PL, GER). Each site will participate in the implementation study with study group á n=33 (total n=165) and control group n=20 (total n=100). The duration of the study is planned for 4 cycles of chemotherapy for each patient and a 3-month follow up period. The first cycle of learning and training at the Outpatient Daily Clinic, then the remaining 3 cycles of blood monitoring at home. The average cycle length is 21-30 days, number of measurements will be determined individually depending on the diagnosis. At a baseline, after 4 cycles of chemotherapy (12-16 weeks) and after a 3-month follow-up period, parallel studies will be carried out in both the study and control groups, using mixed methods the investigators will assess outcomes of reach, effectiveness, adoption, implementation and maintenance (RE-AIM).\n\nExpected benefits:\n\nImplementation of the AMBeR study should reduce the amount of unnecessary and nontherapeutic hospital visits and improve manageability and independence of the patients. The investigators believe that the decrease in the number of hospital visits will diminish the risk of infection for vulnerable individuals, as well as save costs for patients and hospitals. These factors will also translate into better logistics of chemotherapy units, decreased carbon-dioxide trail, and improved quality of life and patient empowerment.",[165,166,167,168,169,113],"Cancer","Cancer-related Problem\u002FCondition","Chemotherapy","Chemotherapy-induced Neutropenia","Chemotherapy Induced Anaemia",[171,172,173,174,175,176,177,178,179,180],"home blood monitoring","complete blood count","cancer","chemotherapy","implementation","research","e-health","oncology","home-based","feasibility","2026-02-26",{"date":183,"type":62},"2026-02-27",{"date":185,"type":62},"2025-03-17",{"date":187,"type":21},"2027-03-31",{"name":189,"class":69},"Pomeranian Medical University Szczecin",5,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":197,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100624362","phase-2-a-clinical-study-on-the-efficacy-and-safety-of-hetrombopag-in-the-treatment-of-thrombocytopenia-induced-by-gynecological-tumor-therapy-100624362","NCT07408648","A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological Tumor Therapy","Key eligibility criteria:\n\n1. Female, aged 18-75 years (inclusive).\n2. Histopathologically or cytologically confirmed ovarian, cervical, endometrial, or other gynecologic malignancy.\n3. Thrombocytopenia (platelet count \\\u003C 75 × 10⁹\u002FL) attributable to anti-cancer therapy, with ≥ 2 further treatment cycles planned.\n4. ECOG performance status 0-1.\n5. Estimated life expectancy ≥ 12 weeks.\n6. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before first dose, not be breastfeeding, and agree to use effective contraception from study entry through 7 days after the last dose.\n7. Able to provide written informed consent and comply with study procedures.\n\nExclusion criteria:\n\n1. Pregnant or lactating women.\n2. Unable to understand the study nature or give informed consent.\n3. History of any arterial or venous thrombosis (stroke, TIA, MI, DVT, PE) or clinical\u002Flaboratory evidence of thrombophilia.\n4. Cardiac disease within 3 months before screening: NYHA class III\u002FIV heart failure, symptomatic arrhythmia requiring therapy, MI, arrhythmias increasing thrombotic risk (e.g., atrial fibrillation), or QTc prolongation.\n5. Thrombocytopenia not related to anti-cancer therapy, active severe bleeding, or refractory persistent thrombocytopenia.\n6. Significant hepatic impairment:\n\n   * No liver metastases: ALT\u002FAST \\> 3 × ULN or TBL \\> 3 × ULN\n   * Liver metastases: ALT\u002FAST ≥ 5 × ULN or TBL ≥ 5 × ULN\n7. Known or suspected hypersensitivity\u002Fintolerance to TPO-receptor agonists or hetrombopag excipients.\n8. Concomitant use of agents that may affect platelet count (e.g., Chinese herbal medicines, other thrombopoietic agents, antiplatelet drugs).\n9. Receipt within 1 month before screening of TPO-RAs (eltrombopag, romiplostim, etc.), rhTPO, or rhIL-11.\n10. Platelet transfusion within 3 days before randomisation\u002Ffirst dose.\n11. Any condition that, in the investigator's opinion, renders the patient unsuitable for the study.","FEMALE","75 Years",{"count":200,"type":21},244,[24],"The study consists of five sequential periods:\n\n* Screening (≤ 4 weeks)\n* Correction phase\n* Maintenance phase (first treatment cycle, Cycle 1)\n* Observation phase (second treatment cycle, Cycle 2)\n* Follow-up Eligible subjects are gynaecological-cancer patients who developed ≥ grade-2 cancer-therapy-induced thrombocytopenia (CTIT) after anti-tumour therapy, i.e. platelet count \\\u003C 75 × 10⁹\u002FL.\n\n  * Stage 1\\*\\* - Prospective, multicentre, randomised clinical study (to inform the confirmatory stage 2) \\*\\*Cohort 1 (n = 30)\\*\\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹\u002FL. Within 24 h after completion of Cycle 1 anti-cancer therapy (end of chemotherapy if combined; otherwise end of investigational product on that day) restart hetrombopag 7.5 mg p.o. daily and continue until the last day of Cycle 1 (C1D21).\n\n\\*\\*Cohort 2 (n = 30)\\*\\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹\u002FL. During Cycle 1, monitor PLT closely; if PLT falls \\\u003C 75 × 10⁹\u002FL, initiate hetrombopag 7.5 mg p.o. daily and continue until C1D21.\n\n\\*\\*Stage 2\\*\\* - Prospective, multicentre, randomised, controlled clinical study \\*(preliminary design; sample size and details will be refined after stage-1 results)\\* \\*\\*Experimental arm (n = 92)\\*\\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹\u002FL. Restart within 24 h after completion of Cycle 1 therapy and continue daily until C1D21.\n\n\\*\\*Control arm (n = 92)\\*\\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹\u002FL. During Cycle 1, monitor PLT; if PLT \\\u003C 75 × 10⁹\u002FL, initiate hetrombopag 7.5 mg p.o. daily until C1D21.\n\n\\*\\*Correction-phase rules\\*\\* Discontinue hetrombopag once PLT ≥ 100 × 10⁹\u002FL. If after ≥ 14 days of hetrombopag correction PLT remains \\\u003C 100 × 10⁹\u002FL and the next treatment cycle has not started, the investigator may resume hetrombopag or institute alternative platelet-enhancing rescue therapy at their discretion.",[113],"NOT_YET_RECRUITING","2026-02-12",{"date":207,"type":62},"2026-02-13",{"date":209,"type":21},"2026-04-15",{"date":211,"type":21},"2027-06-30",{"name":213,"class":69},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":70},"100597802","phase-2-romiplostim-n01-for-chemotherapy-induced-thrombocytopenia-100597802","NCT07063225","Romiplostim N01 for Chemotherapy-induced Thrombocytopenia","Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study","Inclusion Criteria:\n\n* Age: 18 years or above, gender not restricted;\n* Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u\u002Fkg\u002Fd or higher, and the platelet count remains less than 30×10\\^9\u002FL, defined as refractory CTIT);\n* Patients who have stopped chemotherapy and radiotherapy for more than 1 month;\n* Patients with platelet count at enrollment \\\u003C 30×10\\^9\u002FL;\n* Patients with platelet count remains \\\u003C 30×10\\^9\u002FL for more than 1 month;\n* Patients with expected survival period ≥ 6 months;\n* Patients with liver and kidney function \\\u003C 1.5× upper limit of normal value, physical examination qualified;\n* Patients with ECOG physical status score ≤ 2 points;\n* Patients with Cardiac function: New York Heart Association cardiac function classification is grade 2 or below;\n* Patients who is voluntary to sign the informed consent form;\n\nExclusion Criteria:\n\n* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；\n* Patients with poor compliance;\n* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and\u002For hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.\n* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past；\n* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；\n* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；\n* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；\n* Patients with sepsis or patients with other irregular bleeding；\n* Patients taking antiplatelet drugs at the same time；\n* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients； Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \\[NYHA\\] Grade III\u002FIV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \\>450msec or QTc \\> 480 for patients with a Bundle Branch Block;\n* Researchers believe that patients should not participate in the test of any other condition.",{"count":105,"type":21},[24],"To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors",[225,42],"Chemotherapy-induced Thrombocytopenia","2025-07-03",{"date":228,"type":62},"2025-07-14",{"date":230,"type":21},"2025-08",{"date":232,"type":21},"2026-08",{"name":234,"class":69},"Institute of Hematology & Blood Diseases Hospital, China",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":70},"100457437","phase-2-herombopag-for-chemotherapy-induced-thrombocytopenia-100457437","NCT05236582","Herombopag for Chemotherapy-induced Thrombocytopenia","Herombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors","Inclusion Criteria:\n\n* Aged ≥18 years old, male or female;\n* Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；\n* Stop radiotherapy or chemotherapy for more than 1 month;\n* Platelet counts \\\u003C30 ×10\\^9\u002FL, and bleeding tendency;\n* Estimated survival period ≥ 6 months；\n* People who are willing to sign the informed consent voluntarily and follow the research program.\n* Liver and kidney function\\\u003C1.5×upper limit of normal, qualified for physical examination；\n* Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;\n\nExclusion Criteria:\n\n* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；\n* Patients with poor compliance;\n* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and\u002For hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.\n* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past；\n* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；\n* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；\n* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；\n* Patients with sepsis or patients with other irregular bleeding；\n* Patients taking antiplatelet drugs at the same time；\n* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；\n* Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \\[NYHA\\] Grade III\u002FIV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \\>450msec or QTc \\> 480 for patients with a Bundle Branch Block;\n* Researchers believe that patients should not participate in the test of any other condition.",{"count":105,"type":21},[24],"To evaluate the efficacy and safety of Herombopag to treat chemotherapy-induced thrombocytopenia in Solid Tumors",[225,246],"Herombopag","2025-02-20",{"date":249,"type":62},"2025-02-24",{"date":251,"type":62},"2022-03-14",{"date":253,"type":21},"2025-12-31",{"name":234,"class":69},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":270,"locationsCount":70},"100408629","phase-2-eltrombopag-for-chemotherapy-induced-thrombocytopenia-100408629","NCT04600960","Eltrombopag for Chemotherapy-induced Thrombocytopenia","Eltrombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors",{"count":105,"type":21},[24],"To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors",[225,265],"Eltrombopag",{"date":249,"type":62},{"date":268,"type":62},"2020-12-31",{"date":253,"type":21},{"name":234,"class":69},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100511805","phase-2-hetrombopag-for-the-treatment-of-chemotherapy-induced-thrombocytopeniacit-in-patients-with-acute-myeloid-leukemia-100511805","NCT05944211","Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia","A Randomized, Controlled Study on the Efficacy and Safety of Hetrombopag in the Treatment of Chemotherapy-induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia","H-CIT-AML","Inclusion Criteria:\n\n* Ages 18-70;\n* Participant with a histologically or cytologically confirmed acute myeloid leukemia in complete remission (PLT≥100×109\u002FL) (except acute promyelocytic leukemia);\n* Participant who have completed induction therapy and achieved complete remission, have received ≤1 course of intensive consolidation chemotherapy, and will continue to receive intensive consolidation or maintenance chemotherapy;\n* Intensive chemotherapy after complete remission including: high-dose or medium-dose cytarabine chemotherapy (1-1.5g\u002Fm2 q12h×3 days), standard-dose chemotherapy (cytarabine combined with anthracycline\u002Fanthraquinones, HHT, pohyllotoxin, etc.);\n* Participant whose Expected survival time ≥3 months, and who can receive at least 2 cycles of intensive chemotherapy;\n* ECOG performance status \\\u003C=2;\n* Participants of childbearing age who agree to use reliable contraceptive methods;\n* Patients signed the informed consent form and volunteered to participate in this study with good compliance;\n\nExclusion Criteria:\n\n* Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;\n* Participant has a history of arterial or venous thrombosis within 6 months before screening (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or has clinical symptoms and medical history suggestive of thrombophilia;\n* Participant has a history of severe cardiovascular disease within 6 months before screening, such as congestive heart failure (NYHA class III-IV), arrhythmia known to increase the risk of thromboembolism (atrial fibrillation), post-coronary stent implantation, angioplasty, or coronary artery bypass grafting;\n* Known human immunodeficiency virus infection,or hepatitis C infection (if hepatitis B surface antigen is positive, or hepatitis B surface antigen is negative but hepatitis B core antibody is positive, HBV-DNA testing is required, if virus replication is suggested, the subject should be excluded);\n* Abnormal liver function (TBL\\>3xULN; alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\]\\>3xULN);\n* Abnormal renal function with serum creatinine\\>1.5xULN or creatinine clearance ≤ 60 ml\u002Fmin using Cockcroft-Gault estimated creatinine clearance;\n* Pregnant or lactating women, or those planning to receive\u002Fgive birth in the near 6 months;\n* Participant participated in other clinical trials within 3 months before enrollment;\n* Previous use of thrombopoietin receptor agonist (TPO-RA), recombinant human TPO, recombinant human interleukin-11(rhlL-11) within 1 month before screening;\n* Received platelet transfusions within 3 days before enrollment;\n* Patients with known or expected allergy or intolerance to the active ingredient or excipients of hetrombopag;\n* Inability to understand the nature of the study or failure to obtain informed consent;\n* The investigator considers that there are any other conditions that may prevent the subject from completing the study or present a significant risk to the subject;","70 Years",{"count":281,"type":21},72,[24],"Randomized, controlled, open study to evaluate the efficacy and safety of Hetrombopag in the treatment of chemotherapy-induced thrombocytopenia(CIT) in patients with acute myeloid leukemia",[28],[28,286,287],"Acute Myeloid Leukemia","Hetrombopag","2023-07-05",{"date":290,"type":62},"2023-07-13",{"date":292,"type":21},"2023-07",{"date":294,"type":21},"2027-01",{"name":296,"class":69},"RenJi Hospital"]