Clinical trials: Viral Infections After HSCT
BKV Infection, EBV Infection
Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after…
- Conditions
- BKV Infection, EBV Infection, CMV Infection
- Trial name
- NCT07670468
- Testing
- LB-DTK-MV
- Where
- South Korea
- Volunteers
- 27 people
- Sponsor
- LucasBio
Cytomegalovirus (CMV) Infection
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age…
- Trial name
- NCT03940586
- Testing
- Letermovir oral granules, Letermovir tablet, Letermovir intravenous
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 65 people
- Sponsor
- Merck Sharp & Dohme LLC
Cytomegalovirus Infection, Hematopoietic Stem Cells Transplantation
Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and…
- Trial name
- CMV PED (NCT06916195)
- Where
- 5 sites in Italy
- Volunteers
- 230 people
- Sponsor
- MSD Italia S.r.l.
BK Virus Infection
Most Closely Human Leukocyte Antigen (HLA)-Matched BK Virus-specific T Lymphocytes (Viralym-B)
Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection.
- Trial name
- NCT02313844
- Testing
- Viralym-B
- Where
- 2 sites in United States
- Sponsor
- AlloVir
Adenovirus Infections
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia.
- Trial name
- ENOVIA (NCT07387367)
- Testing
- cidofovir, Brincidofovir
- Where
- 81 sites in United States, Austria and 11 more
- Volunteers
- 180 people
- Sponsor
- SymBio Pharmaceuticals
Adenovirus Infection
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
- Trial name
- NCT05179057
- Testing
- Posoleucel
- Where
- 47 sites in United States, Canada and 4 more
- Volunteers
- 57 people
- Sponsor
- AlloVir
Viruria
CMX001 in Post-transplant Patients With BK Virus Viruria
This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus viruria.
- Trial name
- NCT00793598
- Testing
- Brincidofovir
- Where
- 15 sites in United States
- Volunteers
- 29 people
- Sponsor
- Jazz Pharmaceuticals
Hemorrhagic Cystitis
Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation
The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem…
- Trial name
- NCT07638332
- Testing
- LB-DTK-BKV, Standard-of-care
- Where
- 9 sites in South Korea
- Volunteers
- 42 people
- Sponsor
- LucasBio
Cytomegalovirus Infection
Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)
The purpose of this study was to evaluate the safety and efficacy of letermovir (LET) versus placebo when cytomegalovirus (CMV) prophylaxis was extended from 100 days to 200 days post-transplant in CMV seropositive participants…
- Trial name
- NCT03930615
- Testing
- Letermovir
- Where
- 32 sites in United States, France and 4 more
- Volunteers
- 220 people
- Sponsor
- Merck Sharp & Dohme LLC
Cytomegalovirus Infection
Cytomegalovirus - Immunoprophylactic Adoptive Cellular Therapy Study
The purpose of this study is to evaluate the potential clinical benefit of prophylactic cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT)…
- Trial name
- CMV-IMPACT (NCT01077908)
- Testing
- Adoptive Cellular Therapy, Best available antiviral drug therapy
- Where
- 14 sites in United Kingdom
- Volunteers
- 89 people
- Sponsor
- Cell Medica Ltd
Adenovirus Infection
Most Closely Human Leukocyte Antigen (HLA)-Matched Adenovirus-specific T Lymphocytes (Viralym-A)
Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection.
- Trial name
- NCT02276820
- Testing
- Viralym-A
- Where
- 2 sites in United States
- Sponsor
- AlloVir
B-cell Acute Lymphoblastic Leukemia
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.
- Trial name
- ELIANA (NCT02435849)
- Testing
- CTL019
- Where
- 23 sites in United States, Australia and 9 more
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and…
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Trial name
- NCT02822495
- Testing
- tabelecleucel
- Sponsor
- Atara Biotherapeutics
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the…
- Conditions
- Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant
- Trial name
- ALLELE (NCT03394365)
- Testing
- tabelecleucel
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 115 people
- Sponsor
- Pierre Fabre Medicament
Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
- Conditions
- Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
- Trial name
- NCT04554914
- Testing
- Tabelecleucel
- Where
- 40 sites in United States, Austria and 5 more
- Volunteers
- 190 people
- Sponsor
- Pierre Fabre Medicament
CMV Infections
Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C)
Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection.
- Trial name
- NCT02313857
- Testing
- Viralym-C
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- AlloVir
BKV Infection, CMV Infection
Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic…
- Conditions
- BKV Infection, CMV Infection, EBV Infection
- Trial name
- NCT07685457
- Testing
- LB-DTK-MV
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- LucasBio
Viral Infection
ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus
The subjects eligible for this trial have a type of blood cell cancer, other blood disease or a genetic disease for which they will receive a stem cell transplant.
- Trial name
- ARMS (NCT01570283)
- Testing
- Multivirus-specific T cells Dose Level 1, Multivirus-specific T cells Dose Level 2, Multivirus-specific T cells Dose Level 3
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- AlloVir
Cytomegalovirus Infection
Maribavir for Prevention of CMV After Stem Cell Transplants
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy.
- Trial name
- NCT00223925
- Testing
- Maribavir
- Where
- 13 sites in United States
- Volunteers
- 111 people
- Sponsor
- Shire
Infection
Multivirus-specific T Cells for the Treatment of Virus Infections After Stem Cell Transplant
Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection.
- Trial name
- CHARMS (NCT02108522)
- Testing
- Multivirus Specific T cells
- Where
- 2 sites in United States
- Volunteers
- 82 people
- Sponsor
- AlloVir