Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-02 @ 7:18 PM
Study NCT ID:
NCT00986557
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2009-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016219', 'term': 'Immunotherapy, Adoptive'}, {'id': 'D000074323', 'term': 'Alemtuzumab'}, {'id': 'D017245', 'term': 'Foscarnet'}, {'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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'}, {'id': 'D010746', 'term': 'Phosphonoacetic Acid'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '2009-09-29', 'studyFirstSubmitQcDate': '2009-09-29', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CMV reactivation in the first year after ASCT measured by quantitative PCR'}], 'secondaryOutcomes': [{'measure': 'CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT'}, {'measure': 'Time to CMV reactivation'}, {'measure': 'Use of antiviral therapy'}, {'measure': 'Incidence of secondary CMV reactivation and CMV disease'}, {'measure': 'Incidence of acute and chronic graft-versus-host disease'}]}, 'conditionsModule': {'keywords': ['cytomegalovirus infection', 'graft versus host disease'], 'conditions': ['Graft Versus Host Disease', 'Nonneoplastic Condition']}, 'descriptionModule': {'briefSummary': 'RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant.\n\nPURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the frequency of cytomegalovirus (CMV) reactivation during the first year after allogeneic stem cell transplantation (ASCT) in patients at risk for CMV infection treated with adoptive transfer of selected CMV-specific cytotoxic T-lymphocytes.\n\nSecondary\n\n* To monitor CMV-specific immune reconstitution within the first year following ASCT in these patients.\n* To determine the time to CMV reactivation in these patients.\n* To evaluate the use of antiviral therapy in these patients.\n* To determine the incidence of secondary CMV reactivation and CMV disease in patients treated with this regimen.\n* To determine the incidence of acute and chronic graft-versus-host disease.\n\nOUTLINE: This is a multicenter study. After undergoing an allogeneic peripheral blood stem cell transplantation (PBSCT) using an alemtuzumab-based conditioning regimen that also includes radiotherapy, patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive cytomegalovirus (CMV)-specific cytotoxic T-lymphocyte infusion on day 21-90 after allogeneic PBSCT.\n* Arm II: Patients undergo standard follow-up care and receive standard antiviral therapy comprising ganciclovir IV or foscarnet sodium upon detection or confirmation of CMV reactivation.\n\nBlood samples are collected to assess CMV viral load by quantitative PCR.\n\nAfter completion of study therapy, patients are followed once a week for 100 days and then once a month for 1 year.\n\nPROJECTED ACCRUAL: A total of 18 patients with sibling donors and 21 patients with unrelated donors are accrued for each arm, resulting in a total of 78 patients accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Planning allogeneic peripheral blood stem cell transplantation (PBSCT) using a conditioning regimen containing alemtuzumab and radiotherapy\n* Sibling or matched unrelated donor available\n\n * Patients and donor matched for ≥ one of the following HLA alleles:\n\n * HLA-A\\*0101\n * HLA\\*0201\n * HLA-A\\*1101\n * HLA-A\\*2402\n * HLA-B\\*0702\n * HLA-B\\*0801\n * HLA-B\\*3502\n * No donors whose stem cells have already been collected and cryopreserved prior to transplant\n* Patient and donor must be CMV seropositive\n* Stem cell harvests ≥ 4.0 x 10\\^6 CD34 cells/kg\n\nPATIENT CHARACTERISTICS:\n\n* See Disease Characteristics\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior bone marrow transplantation\n* No concurrent participation in another therapeutic transplantation study'}, 'identificationModule': {'nctId': 'NCT00986557', 'briefTitle': 'T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomised Controlled Phase II Trial of the Adoptive Transfer of Selected Cytomegalovirus-Specific Cytotoxic T Lymphocytes (CMV-CTL) After Allogeneic Stem Cell Transplantation (SCT) in Patients at Risk of CMV Disease', 'orgStudyIdInfo': {'id': 'CDR0000650654'}, 'secondaryIdInfos': [{'id': 'CRC-TU-ACE-CMV'}, {'id': '53325562'}, {'id': 'EU-20974'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'adoptive immunotherapy', 'type': 'BIOLOGICAL'}, {'name': 'alemtuzumab', 'type': 'BIOLOGICAL'}, {'name': 'in vitro-treated peripheral blood lymphocyte therapy', 'type': 'BIOLOGICAL'}, {'name': 'foscarnet sodium', 'type': 'DRUG'}, {'name': 'ganciclovir', 'type': 'DRUG'}, {'name': 'polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'allogeneic hematopoietic stem cell transplantation', 'type': 'PROCEDURE'}, {'name': 'infection prophylaxis and management', 'type': 'PROCEDURE'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}, {'name': 'standard follow-up care', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2SG', 'city': 'Birmingham', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Frederick Chen, MD', 'role': 'CONTACT', 'phone': '44-121-253-4174'}], 'facility': 'Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Frederick Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Birmingham', 'class': 'OTHER'}}}}