Nctid:
NCT06613880
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000740", "term"=>"Anemia"}, {"id"=>"D000000741", "term"=>"Anemia, Aplastic"}], "ancestors"=>[{"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000080983", "term"=>"Bone Marrow Failure Disorders"}, {"id"=>"D000001855", "term"=>"Bone Marrow Diseases"}], "browseLeaves"=>[{"id"=>"M4070", "name"=>"Anemia", "asFound"=>"Anemia", "relevance"=>"HIGH"}, {"id"=>"M4071", "name"=>"Anemia, Aplastic", "asFound"=>"Aplastic Anemia", "relevance"=>"HIGH"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2241", "name"=>"Bone Marrow Failure Disorders", "relevance"=>"LOW"}, {"id"=>"M13118", "name"=>"Pancytopenia", "relevance"=>"LOW"}, {"id"=>"M5134", "name"=>"Bone Marrow Diseases", "relevance"=>"LOW"}, {"id"=>"T460", "name"=>"Aplastic Anemia", "asFound"=>"Aplastic Anemia", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M18961", "name"=>"Cyclosporine", "relevance"=>"LOW"}, {"id"=>"M6730", "name"=>"Cyclosporins", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-01-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overall response rate", "timeFrame"=>"Within 27 weeks post treatment", "description"=>"Percentage of patients with hematological response, including complete response (CR) or partial response (PR). Hematological response is evaluated by hemoglobin (Hb), platelet count (PLT) and absolute neutrophil count (ANC)."}], "secondaryOutcomes"=>[{"measure"=>"Overall response rate", "timeFrame"=>"Within 3 months post treatment", "description"=>"Percentage of patients with hematological response, including complete response (CR) or partial response (PR). Hematological response is evaluated by hemoglobin (Hb), platelet count (PLT) and absolute neutrophil count (ANC)."}, {"measure"=>"Time to hematological response", "timeFrame"=>"Within 27 weeks post treatment", "description"=>"Duration time was calculated from enrollment to achieve hematological response."}, {"measure"=>"Incidence of adverse events", "timeFrame"=>"Within 27 weeks post treatment", "description"=>"Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Severe aplastic anemia", "Romiplostim N01"], "conditions"=>["Aplastic Anemia", "Treatment-naïve Acquired Severe Aplastic Anemia", "TPO Receptor Agonists"]}, "descriptionModule"=>{"briefSummary"=>"This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age ≥ 12 years\n* Diagnosis of severe or very severe aplastic anemia\n* Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation\n* ECOG performance status ≤2\n* Willing and able to comply with the requirements for this study and written informed consent.\n\nExclusion Criteria:\n\n* Received \\> 4 weeks of TPO-RA drug before treatment\n* Received \\> 4 weeks of immunosuppressive therapy before treatment\n* History of thromboembolic disease\n* Intolerance to Romiplostim N01 or cyclosporine\n* Allergy to ALG\n* Presence of uncontrolled active infection\n* Presence of uncontrolled hypertension (≥140/90mmHg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L)\n* Abnormal liver and kidney function: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \\> 3 ULN, creatinine ≥ 2.5 ULN\n* History of chemoradiotherapy for malignant solid tumors\n* History of other systemic serious illnesses\n* Females who are pregnant/lactating or need pregnancy\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above"}, "identificationModule"=>{"nctId"=>"NCT06613880", "briefTitle"=>"Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia", "organization"=>{"class"=>"OTHER", "fullName"=>"Institute of Hematology & Blood Diseases Hospital, China"}, "officialTitle"=>"A Prospective, Single Center, Single-arm Study on the Efficacy and Safety of Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia", "orgStudyIdInfo"=>{"id"=>"IH-ROMIST"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"p-ALG+Romiplostim N01+CsA", "description"=>"The maximum screening period was 4 weeks, and after entering the treatment period, the patients were treated with p-ALG combined with cyclosporine and Romiplostim N01. Symptomatic leukocyte elevation, blood transfusion support, and anti-infective therapy are allowed during this period, according to the patient's blood routine. If a patient has a serious adverse event during treatment, it will be treated according to the criteria for suspension and recovery.", "interventionNames"=>["Drug: standard IST combined with Romiplostim N01"]}], "interventions"=>[{"name"=>"standard IST combined with Romiplostim N01", "type"=>"DRUG", "description"=>"Romiplostim N01 is a class of TPO receptor agonists. Its TPO peptide can bind to TPO receptors on megakaryocyte precursors in the bone marrow and activate them, triggering a series of intracellular signalling pathways, including JAK2/STAT5, PI3K/Akt, MEK/ERK, and p38, which ultimately lead to gene transcription and increased megakaryocyte proliferation and differentiation.", "armGroupLabels"=>["p-ALG+Romiplostim N01+CsA"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Tianjin", "state"=>"Tianjin", "country"=>"China", "contacts"=>[{"name"=>"Lele Zhang, PhD", "role"=>"CONTACT", "email"=>"zhanglele@ihcams.ac.cn", "phone"=>"15811139278"}], "facility"=>"Regenerative Medicine Center and Red Blood Cell Disorders Center", "geoPoint"=>{"lat"=>39.14222, "lon"=>117.17667}}], "centralContacts"=>[{"name"=>"Lele Zhang, PhD", "role"=>"CONTACT", "email"=>"zhanglele@ihcams.ac.cn", "phone"=>"15811139278"}, {"name"=>"Meili Ge, PhD", "role"=>"CONTACT"}], "overallOfficials"=>[{"name"=>"Jun Shi, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Institute of Hematology & Blood Diseases Hospital, China"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Institute of Hematology & Blood Diseases Hospital, China", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Qilu Pharmaceutical Co., Ltd.", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Director of the Red Blood Cell Disorders Center & Director of the Regenerative Medicine Clinic", "investigatorFullName"=>"Jun Shi", "investigatorAffiliation"=>"Institute of Hematology & Blood Diseases Hospital, China"}}}}
