Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-10 @ 10:23 AM
Study NCT ID:
NCT02844361
Status:
UNKNOWN
Last Update Posted:
2016-07-26
First Post:
2016-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2016-07-17', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progress-free survival', 'timeFrame': 'up to 36 months'}], 'secondaryOutcomes': [{'measure': 'complete remission rate', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['high-risk', 'ASCT'], 'conditions': ['Waldenström Macroglobulinemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.', 'detailedDescription': "WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 70 years\\>=Aged \\>=18 years\n2. diagnosed with high-risk LPL/WM according to the ISSWM criteria\n3. untreated or mild treated without standard regimens\n4. suitable for ASCT\n5. with life-expectancy more than 3 months.\n\nExclusion Criteria:\n\n1. diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)\n2. transformed lymphoma\n3. liver or renal function lesion unrelated to lymphoma\n4. serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician\n5. HIV positive or active HBV infection or other uncontrolled systematic infection\n6. clinical central nervous dysfunction\n7. serious surgery within 30 days\n8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.'}, 'identificationModule': {'nctId': 'NCT02844361', 'acronym': 'BDH-WM03', 'briefTitle': 'Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China', 'orgStudyIdInfo': {'id': 'ITT2015006-EC-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous stem cell transplantation', 'description': 'Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback', 'interventionNames': ['Other: autologous stem cell transplantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional chemotherapy', 'description': 'Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy', 'interventionNames': ['Other: conventional chemotherapy']}], 'interventions': [{'name': 'autologous stem cell transplantation', 'type': 'OTHER', 'description': 'Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback', 'armGroupLabels': ['autologous stem cell transplantation']}, {'name': 'conventional chemotherapy', 'type': 'OTHER', 'description': 'Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy', 'armGroupLabels': ['conventional chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuhua Yi, Doc', 'role': 'CONTACT', 'email': 'yishuhua@ihcams.ac.cn', 'phone': '86-22-23909106'}, {'name': 'Lugui Qiu, Doc', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '86-22-23909172'}], 'facility': 'Shuhua Yi', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Shuhua Yi, Doc', 'role': 'CONTACT', 'email': 'yishuhua@ihcams.ac.cn', 'phone': '86-22-23909106'}, {'name': 'Lugui Qiu, Doc', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '86-22-23909172'}], 'overallOfficials': [{'name': 'Shuhua Yi, Doc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'blood disease hospital, Chinese Academic Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'dependent on the local law'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yi Shuhua', 'investigatorAffiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}}}}