1 фаза клинические исследования у детей (до 17 лет) при цитомегаловирусной инфекции

данные на 03 апреля 2011

RankStatusStudy
1RecruitingTrial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Biological: CMV-Peptide-Specific T cells
Sponsor:Memorial Sloan-Kettering Cancer Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00674648
Other IDs:05-065
First Received Date:May 6, 2008
Start Date:August 2007
Completion Date:August 2011
Last Updated Date:November 2, 2010
Last Verified Date:November 2010
Acronym:
Primary Completion Date:August 2011
Outcome Measures:To assess the safety or toxicities of escalating doses of donor-derived CMV-pp65 peptide-specific T cells.;   To quantitate alterations in the level of CMV antigenemia in the blood of patients with either active infection or persistent antigenemia following adoptive transfer of CMV-pp65 peptide-specific T cells.
2CompletedCytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Other: CMV Specific Cytotoxic T Lymphocytes
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:47
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00673868
Other IDs:26769
First Received Date:May 1, 2008
Start Date:October 2007
Completion Date:
Last Updated Date:January 22, 2009
Last Verified Date:April 2008
Acronym:
Primary Completion Date:
Outcome Measures:The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.;   To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL;   To determine the CMV epitopes recognized by donors;   To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL
3RecruitingAdministration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme
Conditions:Glioblastoma Multiforme;   Brain Cancer
Intervention:Biological: CMV-specific CTL
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine;   The Methodist Hospital System
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01205334
Other IDs:26901-COGLI
First Received Date:September 17, 2010
Start Date:November 2010
Completion Date:November 2020
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:COGLI
Primary Completion Date:November 2020
Outcome Measures:Primary: To evaluate the safety and persistence of escalating doses of autologous CMV-specific cytotoxic T-lymphocytes (CTL) in patients with CMV-positive Glioblastoma multiforme (GBM);   Secondary Objectives: To evaluate the effects of CMV-specific CTL on measurable disease.;   To measure the survival and function of CMV-specific CTL in vivo.
4Unknown Adoptive Immunotherapy for CMV Disease
Condition:CMV Disease
Intervention:Biological: CMV vaccine
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00159055
Other IDs:280303-HMO-CTIL
First Received Date:September 9, 2005
Start Date:February 2004
Completion Date:
Last Updated Date:December 12, 2005
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measures:Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.;   Evaluate toxicity of the procedure.
5TerminatedA Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
Condition:Glioblastoma Multiforme
Interventions:Drug: Fludarabine;   Drug: Cyclophosphamide;   Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:10
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00990496
Other IDs:31717,   PSHCI #09-045
First Received Date:October 5, 2009
Start Date:September 2009
Completion Date:September 2011
Last Updated Date:October 19, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:September 2011
Outcome Measures:To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.;   To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.;   To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.;   To determine safety of allogeneic CTL infusions in this patient population.
6RecruitingSafety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus
Conditions:Cytomegalovirus Infection;   Adenovirus Infection
Intervention:Biological: Dose Escalation Comparison
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00880789
Other IDs:23668-ACT CAT
First Received Date:April 13, 2009
Start Date:May 2009
Completion Date:May 2015
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:ACT-CAT
Primary Completion Date:May 2014
Outcome Measures:To determine safety, toxicity and MTD of one intravenous injection of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV and Adenovirus given to patients with or at risk for CMV and adenovirus disease after cord blood transplant;   To evaluate the feasibility of generating a sufficient number of umbilical cord blood-derived cytotoxic T lymphocytes (CTLs) specific for CMV and Adenovirus;   To evaluate the impact of these CTLs on Adenovirus-specific T-lymphocyte immune reconstitution.;   To evaluate the recovery of virus-specific immunity after CTL infusion and its correlation with viral clearance and/or protection from viral infection/disease.
7RecruitingStudy of Administration of CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM
Condition:Brain Cancer
Intervention:Drug: HER.CAR CMV-specific CTL
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01109095
Other IDs:H-24487 - HERT GBM
First Received Date:April 13, 2010
Start Date:October 2010
Completion Date:October 2031
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:HERT-GBM
Primary Completion Date:October 2016
Outcome Measures:Evaluating the safety and persistence of escalating doses CTL;   Evaluating and Measuring the effects of gene modified CTL
8CompletedPhase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease
Condition:Cytomegalovirus Infections
Intervention:Drug: SDZ MSL-109
Sponsors:National Center for Research Resources (NCRR);   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phases:Phase I / Phase II
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004642
Other IDs:199/11673,   NIAID-3748
First Received Date:February 24, 2000
Start Date:February 1995
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1999
Acronym:
Primary Completion Date:
Outcome Measure:
9RecruitingCytotoxic T-Lymphocytes for the Prophylaxis of Cytomegalovirus After Allogeneic Stem Cell Transplant
Conditions:Stem Cell Transplantation;   Cytomegalovirus Infections
Intervention:Biological: CMV CTL infusion
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00078533
Other IDs:12683-VICTA,   VICTA
First Received Date:March 1, 2004
Start Date:April 2004
Completion Date:December 2021
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:VICTA
Primary Completion Date:December 2021
Outcome Measures:safety, toxicity and maximum tolerated dose (MTD);   Efficacy of recovery of virus-specific immunity and correlation with protection from viral reactivation/disease.
10RecruitingInjection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
Conditions:Cytomegalovirus Infections;   Adenovirus Infections
Intervention:Other: Cell therapy
Sponsor:Assistance Publique - Hôpitaux de Paris
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01325636
Other IDs:P090801
First Received Date:March 28, 2011
Start Date:March 2010
Completion Date:September 2012
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:CTLantiCMV
Primary Completion Date:September 2012
Outcome Measures:CMV blood viral load by PCR;   GvHa evaluation;   Evaluation of clinical signs according to interested organs (lung, liver, bowel,…);   Increase of T cells
11CompletedValganciclovir in Congenital CMV Infants
Condition:Cytomegalovirus Infections
Interventions:Drug: Valganciclovir;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phases:Phase I / Phase II
Number Enrolled:24
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00031434
Other IDs:01-595,   CASG 109
First Received Date:March 6, 2002
Start Date:July 2002
Completion Date:July 2007
Last Updated Date:February 3, 2011
Last Verified Date:July 2009
Acronym:
Primary Completion Date:July 2007
Outcome Measures:Pharmacokinetics of ganciclovir following administration of oral valganciclovir syrup. The pharmacokinetics will be assessed by a population approach to PK data analysis.;   Pharmacokinetics of valganciclovir following administration of oral valganciclovir syrup.;   Lack of vomiting and/or diarrhea associated with administration of oral valganciclovir syrup.;   Correlation of ganciclovir plasma concentrations following administration of intravenous ganciclovir and oral valganciclovir syrup with CMV whole blood viral load.;   Assessment of toxicity, such as neutropenia, associated with the administration of oral valganciclovir syrup.
12CompletedFoscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:53
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000726
Other IDs:ACTG 015,   FDA 20D
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:February 1992
Acronym:
Primary Completion Date:
Outcome Measure:
13TerminatedA Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease
Conditions:Cytomegalovirus Infections;   Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Cidofovir;   Drug: Probenecid
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phase:Phase I
Number Enrolled:14
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Primary Purpose: Treatment
NCT ID:NCT00000881
Other IDs:ACTG 352
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:September 1998
Acronym:
Primary Completion Date:
Outcome Measure:
14CompletedA Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:38
Funded By:NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000673
Other IDs:ACTG 085
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
15TerminatedA Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.
Conditions:Encephalopathy;   HIV Infections;   Radiculitis
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000856
Other IDs:ACTG 305
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:March 2004
Acronym:
Primary Completion Date:
Outcome Measure:
16RecruitingSafety Study of Recombinant Adeno-Associated Virus Acid Alpha-Glucosidase to Treat Pompe Disease
Condition:Pompe Disease
Intervention:Drug: rAAV1-CMV-GAA
Sponsors:University of Florida;   National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Group:Child
Phases:Phase I / Phase II
Number Enrolled:6
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00976352
Other IDs:PGTC PD-AAV004
First Received Date:July 13, 2009
Start Date:September 2010
Completion Date:January 2013
Last Updated Date:November 16, 2010
Last Verified Date:November 2010
Acronym:
Primary Completion Date:December 2012
Outcome Measures:Assessment of the safety of intramuscular administration of a recombinant adeno-associated virus, rAAV1-CMV-GAA, vector in children with ventilator-dependent Pompe disease.;   Impact of gene transfer to the diaphragm will be assessed by detailed pulmonary function studies
17RecruitingMost Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)
Conditions:Adenovirus Infection;   EBV Infection
Intervention:Biological: Most Closely Matched CTLs with Adenovirus
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Brigham and Women's Hospital;   Massachusetts General Hospital;   M.D. Anderson Cancer Center;   National Marrow Donor Program;   The EMMES Corporation;   Duke University;   Beth Israel Deaconess Medical Center;   Children's Hospital Los Angeles;   National Heart, Lung, and Blood Institute (NHLBI);   Children's Hospital Boston;   University of Miami;   Hackensack University Medical Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:45
Funded By:Other / Industry / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00711035
Other IDs:22994-CHALLAH,   CHALLAH
First Received Date:June 20, 2008
Start Date:November 2008
Completion Date:July 2012
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:CHALLAH
Primary Completion Date:July 2010
Outcome Measure:The primary purpose of the study is to assess the safety of administering CHM-CTLs in transplant patients with EBV, CMV, or adenovirus infection. We have elected to use a dose of 2 x 107 CHM-CTLs/m2.
18CompletedA Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Astra USA;   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000970
Other IDs:ACTG 151
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
19RecruitingDonor Lymphocytes in Preventing and Treating Cytomegalovirus Infection or Adenovirus Infection in Patients Who Have Undergone Umbilical Cord Blood Transplant
Condition:Cancer
Interventions:Biological: allogeneic CMV/AdV-specific cytotoxic T lymphocytes;   Other: laboratory biomarker analysis
Sponsors:Baylor College of Medicine;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Supportive Care
NCT ID:NCT01017705
Other IDs:CDR0000659669,   BCM-H-23668
First Received Date:November 20, 2009
Start Date:November 2009
Completion Date:
Last Updated Date:April 9, 2010
Last Verified Date:December 2009
Acronym:
Primary Completion Date:March 2011
Outcome Measures:Safety of cytotoxic T-cell lymphocytes (CTL) as assessed by CTEP Active version of the NCI CTCAE at 30-45 days after CTL infusion;   Viral load of cytomegalovirus and adenovirus as assessed by PCR before CTL infusion and then weekly for up to 60 days after CTL infusion;   Reconstitution of antiviral immunity as assessed by ELISPOT assays or tetramer assays;   Systemic infections occurring within 6 months of CTL infusion;   Secondary graft failure as assessed for 30 days after CTL infusion
20Unknown Safety Study of Mini-Dystrophin Gene to Treat Duchenne Muscular Dystrophy
Condition:Duchenne Muscular Dystrophy
Intervention:Genetic: rAAV vector expressing Mini-Dystrophin with CMV promoter
Sponsors:Nationwide Children's Hospital;   Asklepios Biopharmaceutical Inc.
Gender:Male
Group:Child
Phase:Phase I
Number Enrolled:6
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00428935
Other IDs:CCRI IRB05-00118
First Received Date:January 26, 2007
Start Date:March 2006
Completion Date:December 2008
Last Updated Date:March 18, 2007
Last Verified Date:March 2007
Acronym:
Primary Completion Date:
Outcome Measures:Safety;   mini-dystrophin gene expression at the site of gene transfer;   muscle strength evaluated by Maximal Volume Isometric Contraction Testing

RankStatusStudy
21Unknown Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
Condition:Cancer
Interventions:Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: immunologic technique;   Other: laboratory biomarker analysis
Sponsor:Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00509691
Other IDs:CDR0000557037,   PSCI-25114
First Received Date:July 30, 2007
Start Date:June 2007
Completion Date:
Last Updated Date:September 16, 2010
Last Verified Date:October 2007
Acronym:
Primary Completion Date:
Outcome Measures:Toxicity;   Treatment failure;   Safety;   Time to development of cytomegalovirus (CMV) specific immune reconstitution;   CMV DNA levels;   Time during post-infusion follow up at which the dominant CMV pp65 epitope for the donor is recognized by the cytotoxic t-cell lymphocyte recipient
22RecruitingMulti-Virus-Specific Cytotoxic T Lymphocytes (CTLs)
Condition:Acute Lymphoblastic Leukemia
Intervention:Biological: Genetically modified T cells
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00840853
Other IDs:23637-MULTIPRAT
First Received Date:February 9, 2009
Start Date:April 2009
Completion Date:April 2029
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:MULTIPRAT
Primary Completion Date:April 2014
Outcome Measures:Evaluate safety/persistence of escalating doses of allogeneic CMV, EBV and Adenovirus specific CTLs modified to express artificial T-cell receptors targeting CD19 molecule given for prophylaxis, persistence or relapse of high risk B-cell ALL post HSCT;   To evaluate the effects of gene modified CTL on measurable disease.;   To evaluate the impact of the gene modified CTL on virus-specific T-lymphocyte immune reconstitution.;   To evaluate the impact of the gene modified CTL on normal CD19+ B-cell immune reconstitution post-HSCT.
23CompletedA Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:48
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000668
Other IDs:ACTG 127,   ICM 1505,   FDA 37A,   RS-21592
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 25, 2008
Last Verified Date:March 1991
Acronym:
Primary Completion Date:
Outcome Measure:
24CompletedVirus-Specific Cytotoxic T-Lymphocytes (CTLs) for Adenovirus Infection Following an Allogeneic Stem Cell Transplant
Condition:Adenoviridae Infections
Interventions:Genetic: Cytomegalovirus (CMV)-specific Cytotoxic T-Lymphocytes (CTL);   Genetic: Epstein-Barr Virus (EBV)-specific Cytotoxic T-Lymphocytes (CTL)
Sponsors:National Heart, Lung, and Blood Institute (NHLBI);   Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:NIH / Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00111033
Other IDs:436,   U54 HL081007-01,   LYPTAIST,   14097
First Received Date:May 16, 2005
Start Date:September 2003
Completion Date:June 2008
Last Updated Date:September 29, 2008
Last Verified Date:September 2008
Acronym:
Primary Completion Date:June 2008
Outcome Measure:Maximum tolerated dose of AdV-CTL (i.e., dose with the probability closest to the target toxicity rate at the following termination points: preinfusion, 24 hours post-infusion [optional], Day 3 or 4 [optional], and 1, 2, 4, 6, and 8 weeks post-infusion)
25Active, not recruitingEmergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
Condition:Cancer
Interventions:Biological: cytomegalovirus IE-1-specific cytotoxic T lymphocytes;   Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes;   Biological: therapeutic allogeneic lymphocytes;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: immunological diagnostic method;   Other: laboratory biomarker analysis
Sponsors:Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00769613
Other IDs:CDR0000615167,   PSCI-PSHCI-08-051
First Received Date:October 8, 2008
Start Date:August 2008
Completion Date:
Last Updated Date:September 18, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:August 2014
Outcome Measures:Safety;   Toxicity;   Time to development of cytomegalovirus (CMV)-specific immune reconstitution;   CMV DNA levels;   Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL);   Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
26CompletedA Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
Conditions:Colitis;   HIV Infections
Interventions:Drug: Glutamic acid hydrochloride;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:24
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Primary Purpose: Treatment
NCT ID:NCT00000768
Other IDs:ACTG 183
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 25, 2008
Last Verified Date:August 1998
Acronym:
Primary Completion Date:
Outcome Measure:
27CompletedA Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:25
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001062
Other IDs:ACTG 278
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 1, 2008
Last Verified Date:December 1996
Acronym:
Primary Completion Date:
Outcome Measure:
28CompletedT Lymphocytes and Anti-CD45 Monoclonal Antibody in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer
Condition:Head and Neck Cancer
Interventions:Biological: anti-CD45 monoclonal antibody;   Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Sponsor:Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00608257
Other IDs:CDR0000582383,   BCM-H-14214,   BCM-CLANC
First Received Date:February 1, 2008
Start Date:September 2003
Completion Date:
Last Updated Date:April 18, 2009
Last Verified Date:November 2008
Acronym:
Primary Completion Date:November 2008
Outcome Measures:Maximum tolerated dose of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in combination with anti-CD45 monoclonal antibody;   Safety;   Changes in laboratory data at baseline, 2, 4, 6, and 8 weeks and at 3 months;   Extent and duration of immune depletion at pre-antibody infusion, pre-CTL infusion, 4 hours after infusion on days 3 and 4, and at 1, 2, 4, 6, and 8 weeks post-CTL infusion;   Immunologic function as measured by interferon-gamma, percentage of tetramer-positive cells in peripheral blood, and EBV-DNA in plasma;   Frequency of T-cells specific for CMV antigens (or for adenovirus in CMV-seronegative individuals) and EBV antigens at each time point of follow-up;   Correlation between endogenously reconstituted versus adoptively transferred T-cells;   Overall response rate
29Unknown A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:32
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000805
Other IDs:ACTG 226
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 11, 2008
Last Verified Date:August 2004
Acronym:
Primary Completion Date:
Outcome Measure:


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