Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 10:09 AM
Study NCT ID:
NCT06254560
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000741', 'term': 'Anemia, Aplastic'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The response and complete remission rate with Rituximab protocol.', 'timeFrame': '6 months', 'description': 'Response will be evaluated at each clinic visit. Complete response (CR) was defined as achieving all three peripheral blood count criteria: (1) Hb level up to the normal range; (2) ANC≥1.5×109/L; (3) PLT≥100×109/L. Partial response (PR) was defined as transfusion independent, no longer meeting criteria for severe disease. Persistence of transfusion requirement or death was evidence of no response (NR).'}], 'secondaryOutcomes': [{'measure': 'Relapse rate', 'timeFrame': '12 months and 60 months', 'description': 'Relapse was defined as a responder who met criteria for SAA again after achieving response and keeping stable blood counts for at least 3 months.'}, {'measure': 'Sustained response (SR)', 'timeFrame': '12 months and 60 months', 'description': 'SR was defined as Hb \\> 10 g/dL at 12 months and 60 months, in the absence of any treatment.'}, {'measure': 'Survival', 'timeFrame': '60 months', 'description': 'Survival rate within 5 years after diagnosis'}, {'measure': 'Clonal evolution to myelodysplasia and acute leukemia.', 'timeFrame': '60 months', 'description': 'Clonal evolution within 5 years after diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe aplastic anemia', 'Platelet transfusion refractoriness', 'Rituximab'], 'conditions': ['Severe Aplastic Anemia', 'Platelet Transfusion Refractoriness']}, 'referencesModule': {'references': [{'pmid': '26568159', 'type': 'BACKGROUND', 'citation': 'Killick SB, Bown N, Cavenagh J, Dokal I, Foukaneli T, Hill A, Hillmen P, Ireland R, Kulasekararaj A, Mufti G, Snowden JA, Samarasinghe S, Wood A, Marsh JC; British Society for Standards in Haematology. Guidelines for the diagnosis and management of adult aplastic anaemia. Br J Haematol. 2016 Jan;172(2):187-207. doi: 10.1111/bjh.13853. Epub 2015 Nov 16. No abstract available.'}, {'pmid': '17667077', 'type': 'BACKGROUND', 'citation': 'Chockalingam P, Sacher RA. Management of patients refractory to platelet transfusion. J Infus Nurs. 2007 Jul-Aug;30(4):220-5. doi: 10.1097/01.NAN.0000281531.97183.c0.'}, {'pmid': '18564396', 'type': 'BACKGROUND', 'citation': 'Kerkhoffs JL, Eikenboom JC, van de Watering LM, van Wordragen-Vlaswinkel RJ, Wijermans PW, Brand A. The clinical impact of platelet refractoriness: correlation with bleeding and survival. Transfusion. 2008 Sep;48(9):1959-65. doi: 10.1111/j.1537-2995.2008.01799.x. Epub 2008 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'Due to long-term dependence on platelet transfusion, some severe aplastic anemia (SAA) patients suffer platelet transfusion refractoriness (PTR). Unlike immune thrombocytopenia (ITP), glucocorticoids and human immunoglobulin (IVIg) are generally ineffective for PTR. Due to the lack of effective intervention methods, patients with PTR suffer increased platelet transfusions, bleeding events and treatment costs, prolonged hospital stays, and decreased survival rate. SAA with PTR has become a challenge for physicians. The experiment aims to explore the efficacy of rituximab in the treatment of SAA with PTR, and establish a new effective, safe treatment method with relatively low treatment cost.', 'detailedDescription': 'During the treatment period, Rituximab is administered at a dose of 100mg per week, a total of 4 times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Initial diagnosed SAA with PTR\n* Age\\>18 years old, regardless of gender\n* Initial diagnosed SAA with PTR\n* Age\\>18 years old, regardless of gender\n\nExclusion Criteria:\n\n* Allergy to rituximab\n* Severe active infection\n* Hypogammaglobulinemia\n* Pregnant and lactating women\n* Heart failure (NYHA classification IV)\n* Individuals with epilepsy, dementia, and other mental disorders that require medication treatment who cannot understand or follow the research protocol\n* Chronic infections or other chronic diseases that may be risk to the experiment\n* The researchers believe that it is not suitable for participants'}, 'identificationModule': {'nctId': 'NCT06254560', 'briefTitle': 'Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'The Study of Rituximab in the Treatment of Severe Aplastic Anemia With Platelet Transfusion Refractoriness', 'orgStudyIdInfo': {'id': '2023NCRCA0113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rituximab group', 'description': 'Rituximab combined with cyclosporine', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera'], 'description': 'Rituximab is administered at a dose of 100mg per week, a total of 4 times. Cyclosporin is administered at a dose of 3-5mg/kg per day.', 'armGroupLabels': ['rituximab group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huang Jinbo, M.D.', 'role': 'CONTACT', 'email': 'huangjinbo@ihcams.ac.cn', 'phone': '+86 22 23909023'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Huang Jinbo, MD.', 'role': 'CONTACT', 'email': 'huangjinbo@ihcams.ac.cn', 'phone': '+86 22 23909023'}], 'overallOfficials': [{'name': 'Huang Jinbo, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}