Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-08 @ 12:18 PM
Study NCT ID:
NCT03818334
Status:
RECRUITING
Last Update Posted:
2019-02-01
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C512542', 'term': 'thymoglobulin'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Graft Failure Incidence', 'timeFrame': '2 years', 'description': 'ANC \\< 500/microL after 42 days after graft infusion'}, {'measure': 'Time Until Neutrophil Engraftment', 'timeFrame': '2 years', 'description': 'Time to ANC \\> 500/microL for three consecutive days'}, {'measure': 'Time Until Platelet Engraftment', 'timeFrame': '2 years', 'description': 'Time to platelet count \\> 50,000/microL, without transfusion in the last 7 days'}, {'measure': 'Immunological Reconstitution', 'timeFrame': 'Days +60, +100 and +180', 'description': 'Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56)'}, {'measure': 'Days hospitalized', 'timeFrame': 'First 100 days after graft infusion', 'description': 'Days admitted to the hospital'}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '4 years', 'description': 'Time to last follow-up or death'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '4 years', 'description': 'Time until last follow-up, death or disease relapse'}, {'measure': 'Acute Graft Versus Host Disease', 'timeFrame': '4 years', 'description': 'Time until acute GvHD development'}, {'measure': 'Chronic Graft Versus Host Disease', 'timeFrame': '4 years', 'description': 'Time until chronic GvHD development'}, {'measure': 'Treatment Related Mortality', 'timeFrame': '4 years', 'description': 'Time until death related to HSCT complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone Marrow Transplantation', 'Hematological Malignancies', 'Post-Cy'], 'conditions': ['Bone Marrow Transplant Complications', 'Graft Versus Host Disease', 'Infection Viral', 'Engraft Failure', 'Immunologic Suppression']}, 'referencesModule': {'references': [{'pmid': '22713691', 'type': 'BACKGROUND', 'citation': 'Finke J, Schmoor C, Bethge WA, Ottinger HD, Stelljes M, Zander AR, Volin L, Heim DA, Schwerdtfeger R, Kolbe K, Mayer J, Maertens JA, Linkesch W, Holler E, Koza V, Bornhauser M, Einsele H, Bertz H, Grishina O, Socie G; ATG-Fresenius Trial Group. Prognostic factors affecting outcome after allogeneic transplantation for hematological malignancies from unrelated donors: results from a randomized trial. Biol Blood Marrow Transplant. 2012 Nov;18(11):1716-26. doi: 10.1016/j.bbmt.2012.06.001. Epub 2012 Jun 17.'}, {'pmid': '16635791', 'type': 'BACKGROUND', 'citation': 'Bacigalupo A, Lamparelli T, Barisione G, Bruzzi P, Guidi S, Alessandrino PE, di Bartolomeo P, Oneto R, Bruno B, Sacchi N, van Lint MT, Bosi A; Gruppo Italiano Trapianti Midollo Osseo (GITMO). Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation. Biol Blood Marrow Transplant. 2006 May;12(5):560-5. doi: 10.1016/j.bbmt.2005.12.034.'}, {'pmid': '29330391', 'type': 'BACKGROUND', 'citation': 'Devillier R, Labopin M, Chevallier P, Ledoux MP, Socie G, Huynh A, Bourhis JH, Cahn JY, Roth-Guepin G, Mufti G, Desmier D, Michallet M, Fegueux N, Ciceri F, Baron F, Blaise D, Nagler A, Mohty M. Impact of antithymocyte globulin doses in reduced intensity conditioning before allogeneic transplantation from matched sibling donor for patients with acute myeloid leukemia: a report from the acute leukemia working party of European group of Bone Marrow Transplantation. Bone Marrow Transplant. 2018 Apr;53(4):431-437. doi: 10.1038/s41409-017-0043-y. Epub 2018 Jan 12.'}, {'pmid': '22327226', 'type': 'BACKGROUND', 'citation': 'Saber W, Opie S, Rizzo JD, Zhang MJ, Horowitz MM, Schriber J. Outcomes after matched unrelated donor versus identical sibling hematopoietic cell transplantation in adults with acute myelogenous leukemia. Blood. 2012 Apr 26;119(17):3908-16. doi: 10.1182/blood-2011-09-381699. Epub 2012 Feb 10.'}, {'pmid': '26947769', 'type': 'BACKGROUND', 'citation': 'Mehta RS, Saliba RM, Chen J, Rondon G, Hammerstrom AE, Alousi A, Qazilbash M, Bashir Q, Ahmed S, Popat U, Hosing C, Khouri I, Shpall EJ, Champlin RE, Ciurea SO. Post-transplantation cyclophosphamide versus conventional graft-versus-host disease prophylaxis in mismatched unrelated donor haematopoietic cell transplantation. Br J Haematol. 2016 May;173(3):444-55. doi: 10.1111/bjh.13977. Epub 2016 Mar 7.'}, {'pmid': '27526282', 'type': 'BACKGROUND', 'citation': 'Rashidi A, Slade M, DiPersio JF, Westervelt P, Vij R, Romee R. Post-transplant high-dose cyclophosphamide after HLA-matched vs haploidentical hematopoietic cell transplantation for AML. Bone Marrow Transplant. 2016 Dec;51(12):1561-1564. doi: 10.1038/bmt.2016.217. Epub 2016 Aug 15.'}, {'pmid': '26970381', 'type': 'BACKGROUND', 'citation': 'Moiseev IS, Pirogova OV, Alyanski AL, Babenko EV, Gindina TL, Darskaya EI, Slesarchuk OA, Bondarenko SN, Afanasyev BV. Graft-versus-Host Disease Prophylaxis in Unrelated Peripheral Blood Stem Cell Transplantation with Post-Transplantation Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil. Biol Blood Marrow Transplant. 2016 Jun;22(6):1037-1042. doi: 10.1016/j.bbmt.2016.03.004. Epub 2016 Mar 10.'}, {'pmid': '28049637', 'type': 'BACKGROUND', 'citation': "Kanakry CG, Bolanos-Meade J, Kasamon YL, Zahurak M, Durakovic N, Furlong T, Mielcarek M, Medeot M, Gojo I, Smith BD, Kanakry JA, Borrello IM, Brodsky RA, Gladstone DE, Huff CA, Matsui WH, Swinnen LJ, Cooke KR, Ambinder RF, Fuchs EJ, de Lima MJ, Andersson BS, Varadhan R, O'Donnell PV, Jones RJ, Luznik L. Low immunosuppressive burden after HLA-matched related or unrelated BMT using posttransplantation cyclophosphamide. Blood. 2017 Mar 9;129(10):1389-1393. doi: 10.1182/blood-2016-09-737825. Epub 2017 Jan 3."}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women of Any Age\n* Indication for an HSCT without matched sibling donor\n* Have a matched unrelated donor (HLA 10 x 10 or 9 x 10)\n* Hematological malignancy\n\nExclusion Criteria:\n\n* Acute leukemias not in complete response (that is \\> 5% blast in the bone marrow)\n* Chemorefractory lymphoproliferative disease\n* Active uncontrolled infection\n* HCT-CI \\> 3\n* Severe organic disfunction (heart ejection fraction \\< 45%, glomerular filtration rate \\< 50 mL.hour, pulmonary DLCO \\< 50%)\n* Previous allogeneic bone marrow transplantation\n* Contraindication to cyclophosphamide or ATG'}, 'identificationModule': {'nctId': 'NCT03818334', 'briefTitle': 'Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SGPP 3549-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post Cyclophosphamide', 'description': 'Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35', 'interventionNames': ['Drug: Cyclophosphamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thymoglobulin (ATG)', 'description': 'Thymoglobulin (ATG) total dose 5 mg/Kg from day -4 until day -1 AND Calcineurin Inhibitor from day +5 AND Methotrexate on days +1, +3, +6 and +11', 'interventionNames': ['Drug: ATG']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'Cyclophosphamide 1000 mg/flask', 'armGroupLabels': ['Post Cyclophosphamide']}, {'name': 'ATG', 'type': 'DRUG', 'otherNames': ['Thymoglobulin'], 'description': 'Antihuman T-Lymphocyte Immune Globulin 25 mg/flask', 'armGroupLabels': ['Thymoglobulin (ATG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05652-900', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Mirele Santos', 'role': 'CONTACT', 'email': 'mirele.santos@einstein.br', 'phone': '+112151-0305'}], 'facility': 'Hospita Israelita Albert Eintein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Andreza A Feitosa Ribeiro', 'role': 'CONTACT', 'email': 'andreza.ribeiro@einstein.br', 'phone': '+5511992512523'}], 'overallOfficials': [{'name': 'Andreza A Feitosa Ribeiro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Israelita Albert Einstein'}, {'name': 'Nelson Hamerschlak, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Israelita Albert Einstein'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Physician specialist in Hematopoietic Stem Transplantation, Principal Investigator', 'investigatorFullName': 'Andreza Alice Feitosa Ribeiro', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}}