[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658365":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":47,"interventions":54,"overallOfficials":40,"centralContacts":60,"locations":40,"responsibleParty":66,"collaborators":40,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":40,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":40,"enrollmentInfo":77,"targetDuration":40,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":40,"overallStatus":89,"whyStopped":40,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":40},{"fullName":5,"class":6},"The Affiliated People's Hospital of Ningbo University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":40},[9,13],{"measure":10,"description":11,"timeFrame":12},"Platelet transfusion rate during mobilization period","Proportion of participants receiving at least one platelet transfusion in the mobilization phase.","From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 30 days.",{"measure":14,"description":15,"timeFrame":16},"Incidence of grade ≥2 bleeding events during mobilization period","Proportion of participants experiencing CTCAE v5.0 grade ≥2 bleeding events throughout the stem-cell mobilization cycle.","From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 40 days.",[18,22,25,28,32,36],{"measure":19,"description":20,"timeFrame":21},"Nadir platelet count","The minimum peripheral platelet count observed in mobilization cycle.","From initiation of EAP chemotherapy to completion of the last stem-cell apheresis, assessed up to 40 days.",{"measure":23,"description":24,"timeFrame":16},"Duration of platelet count \u003C20 ×10⁹\u002FL","Number of days with platelet count below 20 ×10⁹\u002FL.",{"measure":26,"description":27,"timeFrame":12},"Proportion of participants with delayed stem-cell apheresis due to severe thrombocytopenia","Percentage of subjects whose apheresis is postponed because of severe thrombocytopenia.",{"measure":29,"description":30,"timeFrame":31},"Stem-cell mobilization success rate","Proportion of participants achieving total CD34⁺ cell yield ≥5 ×10⁶\u002Fkg body weight.","At completion of stem-cell apheresis,assessed up to 30 days.",{"measure":33,"description":34,"timeFrame":35},"Incidence of adverse events","Incidence of thromboembolism, liver injury, severe bone pain, severe infection graded by CTCAE v5.0.","From start of study intervention to completion of stem-cell collection, assessed up to 40 days.",{"measure":37,"description":38,"timeFrame":39},"Length of hospital stay during mobilization","Total hospital days in the mobilization stage.","From admission for EAP mobilization to discharge after apheresis finished,assessed up to 30 days.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NA","SINGLE_GROUP","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Prophylactic early-use rhTPO for chemotherapy-induced thrombocytopenia during EAP-based hematopoieti","EXPERIMENTAL","This is the only interventional arm of this multicenter, prospective, single-arm phase II study. Eligible patients with lymphoma or multiple myeloma receive standard EAP mobilization chemotherapy (etoposide 75 mg\u002Fm² i.v. d1-2, cytarabine 200 mg\u002Fm² q12h i.v. d1-2; pegfilgrastim is administered subcutaneously on day 6 after completion of chemotherapy; dose reduction to 2\u002F3-3\u002F4 of original dose is allowed for patients \\> 65 years or creatinine clearance 30-60 mL\u002Fmin).\n\nAfter EAP chemotherapy, blood routine tests are monitored dynamically. When peripheral platelet count drops to ≤ 80 × 10⁹\u002FL, \\*\\*prophylactic recombinant human thrombopoietin (rhTPO) 300 U\u002Fkg is given subcutaneously once daily\\*\\*. rhTPO administration continues until completion of stem-cell apheresis, platelet recovery \\> 50 × 10⁹\u002FL, or investigator-judged discontinuation.\n\nPlatelet transfusion is only permitted when platelet count \\\u003C 20 × 10⁹\u002FL or active bleeding occurs. Subjects undergo serial laboratory assessments including",[53],"Drug: rhTPO prophylaxis plus EAP stem-cell mobilization",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":40},"DRUG","rhTPO prophylaxis plus EAP stem-cell mobilization","Standard EAP mobilization chemotherapy (etoposide + cytarabine + pegfilgrastim) plus early prophylactic subcutaneous rhTPO 300 U\u002Fkg\u002Fday initiated when platelet ≤80 ×10⁹\u002FL. rhTPO stops after stem-cell collection, platelet recovery \\>50 ×10⁹\u002FL or investigator's decision. Platelet transfusion follows unified trigger criteria: PLT\\\u003C20×10⁹\u002FL or active bleeding.",[49],[61],{"name":62,"role":63,"phone":64,"phoneExt":40,"email":65},"Yuxiao Wang","CONTACT","13486889847","799161574@qq.com",{"type":67,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100658365","phase-2-early-prophylactic-rhtpo-administration-for-thrombocytopenia-associated-with-eap-regimen-based-hematopoietic-stem-cell-mobilization-100658365",false,"NCT07848672","Early Prophylactic rhTPO Administration for Thrombocytopenia Associated With EAP Regimen-Based Hematopoietic Stem Cell Mobilization","A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Early Prophylactic rhTPO for the Prevention of Hematopoietic Stem Cell Mobilization-Related Thrombocytopenia During the EAP Regimen","Inclusion Criteria:\n\n1. Age between 18 and 75 years old.\n2. Confirmed diagnosis of multiple myeloma or B-cell lymphoma, eligible for autologous hematopoietic stem-cell transplantation and planned to receive EAP-based stem-cell mobilization.\n3. Baseline peripheral platelet count ≥ 80 × 10⁹\u002FL.\n4. Adequate cardiac, hepatic and renal function to tolerate EAP-combination chemotherapy.\n5. Willing and able to complete the full-study follow-up procedures.\n6. Voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. Previous history of arterial or venous thromboembolism including pulmonary embolism.\n2. Liver cirrhosis or baseline alanine transaminase (ALT) \\> 2 times upper limit of normal.\n3. Active uncontrolled infection.\n4. Confirmed myelofibrosis.\n5. Pregnant or lactating female subjects.\n6. Known hypersensitivity to recombinant human thrombopoietin (rhTPO).","ALL","18 Years",{"count":78,"type":79},70,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE2","PHASE3","This is a multicenter, prospective, single-arm, phase II clinical study evaluating the early prophylactic use of recombinant human thrombopoietin (rhTPO) to prevent thrombocytopenia associated with the EAP regimen for hematopoietic stem cell mobilization. The EAP regimen consists of etoposide, cytarabine, and pegylated granulocyte colony-stimulating factor (pegfilgrastim) and is used for hematopoietic stem cell mobilization before autologous stem cell transplantation in patients with multiple myeloma and B-cell lymphoma.\n\nSevere thrombocytopenia is a common complication during EAP-based stem cell mobilization and may increase the risk of bleeding and the need for platelet transfusions, and may sometimes delay stem cell collection. In this study, patients whose platelet counts decrease to ≤80 × 10⁹\u002FL after EAP chemotherapy will receive rhTPO early as a preventive treatment. The study will evaluate whether early rhTPO administration can reduce the incidence of clinically significant bleeding and the need for platelet transfusion while maintaining adequate hematopoietic stem cell mobilization.\n\nThe study will also monitor platelet counts, stem cell collection outcomes, and treatment-related adverse events to evaluate the effectiveness and safety of early rhTPO administration.",[86,87,88],"Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Hematopoietic Stem Cell Mobilization","Chemotherapy-Induced Thrombocytopenia","NOT_YET_RECRUITING","2026-09-27",{"date":92,"type":93},"2026-09-30","ACTUAL",{"date":95,"type":79},"2027-01-01",{"date":97,"type":79},"2030-12-01",{"name":5,"class":6}]