Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-16 @ 8:48 PM
Study NCT ID:
NCT01670812
Status:
UNKNOWN
Last Update Posted:
2012-08-22
First Post:
2012-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-19', 'studyFirstSubmitDate': '2012-08-19', 'studyFirstSubmitQcDate': '2012-08-19', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': 'one year', 'description': 'overall response rate after treated by FFP+HDMP+Rituximab regimen'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'one year', 'description': 'progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.'}, {'measure': 'overall survival', 'timeFrame': 'one year', 'description': 'overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'up to 30 days after last dose of treatment', 'description': 'Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic lymphocytic leukemia', 'ultra-high risk', 'fresh frozen plasma', 'methylprednisolone', 'rituximab'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '20635386', 'type': 'BACKGROUND', 'citation': 'Xu W, Miao KR, Zhu DX, Fang C, Zhu HY, Dong HJ, Wang DM, Wu YJ, Qiao C, Li JY. Enhancing the action of rituximab by adding fresh frozen plasma for the treatment of fludarabine refractory chronic lymphocytic leukemia. Int J Cancer. 2011 May 1;128(9):2192-201. doi: 10.1002/ijc.25560.'}, {'pmid': '20627536', 'type': 'BACKGROUND', 'citation': 'Xu W, Miao KR, Hong M, Zhu DX, Fang C, Dong HJ, Wang DM, Cao X, Li JY. High-dose methylprednisolone can induce remissions in patients with fludarabine-refractory chronic lymphocytic leukaemia. Eur J Cancer. 2010 Aug;46(12):2145-9. doi: 10.1016/j.ejca.2010.04.021. Epub 2010 Jun 4.'}, {'pmid': '18310545', 'type': 'BACKGROUND', 'citation': 'Dungarwalla M, Evans SO, Riley U, Catovsky D, Dearden CE, Matutes E. High dose methylprednisolone and rituximab is an effective therapy in advanced refractory chronic lymphocytic leukemia resistant to fludarabine therapy. Haematologica. 2008 Mar;93(3):475-6. doi: 10.3324/haematol.11903.'}, {'pmid': '19758239', 'type': 'BACKGROUND', 'citation': 'Klepfish A, Gilles L, Ioannis K, Rachmilewitz EA, Schattner A. Enhancing the action of rituximab in chronic lymphocytic leukemia by adding fresh frozen plasma: complement/rituximab interactions & clinical results in refractory CLL. Ann N Y Acad Sci. 2009 Sep;1173:865-73. doi: 10.1111/j.1749-6632.2009.04803.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate efficacy and safety of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemia.', 'detailedDescription': 'Chronic lymphocytic leukemia remains incurable and particularly in ultra-high risk subgroup, and the prognosis of these patients is still dismal.\n\nThis is a phase III, multicenter perspective clinical trial of combination of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemiaThe. The main purpose of this study is to investigate efficacy and safety of this combinated regimen in subgroup of CLL patients.\n\nAll the enrolled patients will be followed during and after the treatment period up to one year. Interim and final evaluation will be done after each cycle of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-80 years old.\n2. Diagnosis of chronic lymphocytic leukemia.\n3. Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment.\n4. Ultra-high risk CLL(Meets at least one of the following criteria) (1)ultra high-risk genetics (17p deletion and/or TP53 mutation) (2)short PFS(\\<24 months)after intense immunochemotherapy treatment(i.e. FCR, FR, PCR, BR etc) (3)fludarabine-refractory\n5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n1. Severe allergic constitution or asthma.\n2. Recent myocardial infarction or hypotension.\n3. ECOG performance status of ≤ 2 at study entry.\n4. Active hepatitis B(DNA \\>1×103/ml)\n5. Severe and uncontrolled diabetes mellitus.\n6. Severe and uncontrolled hypertension(BP\\> 150/90 mmHg after treatment).\n7. Active and uncontrolled systematic infection which need treatment of antibiotics.\n8. Clinical symptoms of dysfunction of central nervous system.\n9. Unstable and severe gastrorrhagia and peptic ulcer.\n10. Major surgery within three weeks.\n11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.\n12. In any conditions which investigator considered ineligible for this study'}, 'identificationModule': {'nctId': 'NCT01670812', 'briefTitle': 'Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'JSPH-CLL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FFP+HDMP+Rituximab', 'description': 'Fresh frozen plasma 400ml IV day0, Rituximab: 375 mg/m2 IV day0(after infusion of FFP), methylprednisolone 1g/m2(up to 1.5g) IV day1-day5.', 'interventionNames': ['Drug: FFP+HDMP+Rituximab']}], 'interventions': [{'name': 'FFP+HDMP+Rituximab', 'type': 'DRUG', 'otherNames': ['fresh frozen plasma', 'methylprednisolone', 'rituximab'], 'description': 'This is a single arm, multicenter clinical trial, and the regimen including Fresh frozen plasma 400ml IV day0, Rituximab: 375 mg/m2 IV day0(after infusion of FFP), methylprednisolone 1g/m2(up to 1.5g) IV day1-day5', 'armGroupLabels': ['FFP+HDMP+Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zimin Sun, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'Zmsun_vip@163.com'}, {'name': 'Zimin Sun, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First affiliated Hospital of AnHui Medical Universtiy', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianfeng Zhou, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'zhougene@medmail.com.cn'}, {'name': 'Jianfeng Zhou, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TongJi Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '213003', 'city': 'Changzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'XiangShan Cao, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'XiangShan Cao, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ChangZhou First People's Hospital", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '213011', 'city': 'Changzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Zhou, Dr.', 'role': 'CONTACT'}, {'name': 'Min Zhou, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ChangZhou No.2 People's Hospital", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '223300', 'city': 'HuaiAn', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Yu, Dr.', 'role': 'CONTACT'}, {'name': 'Liang Yu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "HuaiAn First People's Hospital"}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YanLi Xu, Dr.', 'role': 'CONTACT'}, {'name': 'YanLi Xu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "NanJing First People's Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LEI FAN, Dr.', 'role': 'CONTACT', 'phone': '86 25 6813 6034'}, {'name': 'WEI XU, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JiangSu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuemei Sun, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Xuemei Sun, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JiangSu Province Hospital of TCM', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '214023', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Zhuang, M.D.', 'role': 'CONTACT'}, {'name': 'YunFeng Shen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "WuXi People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '212002', 'city': 'Zhenjiang', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zhu, Dr.', 'role': 'CONTACT'}, {'name': 'Yan Zhu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ZhenJiang First People's Hospital", 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Wang, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Xin Wang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aibin Liang, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Aibin Liang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TongJi Medical University affiliated TongJi Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Liu, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Ting Liu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China School of Medicine, West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lugui Qiu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'drqiu99@medmail.com.cn', 'phone': '+86 22 2390 9999'}, {'name': 'Lugui Qiu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'LEI FAN, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'fanlei_fl@yahoo.com.cn', 'phone': '+86 25 6813 6034'}], 'overallOfficials': [{'name': 'Wei Xu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'WEI XU', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}