Clinical trials: Recipients of Allogeneic Stem Cell Transplantation
Prevention of CMV Infection or Disease
Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)
The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT).
- Trial name
- NCT02137772
- Testing
- Letermovir
- Volunteers
- 570 people
- Sponsor
- Merck Sharp & Dohme LLC
Effect of Individualized Nutrition on Quality of Life
Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
Aim Allogeneic stem cell transplantation (allo-SCT) combined with several cycles of intensive chemotherapy is the only curative treatment for several malignant blood diseases.
- Trial name
- NASQ (NCT01181076)
- Testing
- Individualized Nutrition
- Where
- 2 sites in Norway, Russia
- Volunteers
- 119 people
- Sponsor
- Oslo University Hospital
Acute Myeloid Leukemia, Allogeneic Hematopoietic Cell Transplantation
A Study of FMT in Patients With AML Allo HSCT in Recipients
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients).
- Trial name
- NCT03678493
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Pneumococcal Infections
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of…
- Trial name
- NCT03565900
- Testing
- V114, Prevnar 13™, PNEUMOVAX™23
- Where
- 52 sites in United States, Australia and 8 more
- Volunteers
- 277 people
- Sponsor
- Merck Sharp & Dohme LLC
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia in Remission
Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant
This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Chronic Lymphocytic Leukemia
- Trial name
- NCT02506933
- Testing
- Laboratory Biomarker Analysis, Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- City of Hope Medical Center
Graft vs Host Disease
Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation
Hematopoietic stem cell transplantation is a procedure in which a person receives blood forming stem cells from a person called a "donor." The stem cells can be obtained from the hollow part of the hip bone or from blood.
- Trial name
- NCT01665677
- Testing
- Atorvastatin calcium
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Mehdi Hamadani
Cutaneous Squamous Cell Carcinoma, Advanced Cancer
Cemiplimab in AlloSCT/SOT Recipients With CSCC
In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous squamous cell carcinoma in participants who have previously received an allogeneic hematopoietic stem cell transplant or kidney…
- Trial name
- CONTRAC (NCT04339062)
- Testing
- Cemiplimab, Everolimus, Sirolimus
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Dana-Farber Cancer Institute
Hematopoietic Stem Cell Transplant
Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients
High dose chemotherapy and radiation used as preparative regimens in patients undergoing an allogeneic hematopoietic stem cell transplant (HSCT) disrupts intestinal homeostasis by damaging the intestinal epithelium and altering…
- Trial name
- NCT04263597
- Testing
- 2'-fucosyllactose
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Graft Versus Host Disease (GVHD)
Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
- Trial name
- NCT04167514
- Testing
- Alpha-1 antitrypsin (AAT)
- Where
- 25 sites in United States
- Volunteers
- 136 people
- Sponsor
- CSL Behring
Breast Cancer, Iron Overload
Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant.
- Conditions
- Breast Cancer, Iron Overload, Leukemia, Lymphoma
- Trial name
- NCT00602446
- Testing
- deferasirox
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Adenovirus
The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation
This study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV)…
- Trial name
- AdAPT (NCT03339401)
- Testing
- Standard of Care, Brincidofovir
- Where
- 36 sites in United States, France and 7 more
- Volunteers
- 29 people
- Sponsor
- Jazz Pharmaceuticals
Malignancy, Metabolic Disease
Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing…
- Conditions
- Malignancy, Metabolic Disease, Genetic Disorder
- Trial name
- NCT01135537
- Testing
- Thymoglobulin (rATG)
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- The Hospital for Sick Children
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia
- Trial name
- Orca-T (NCT05316701)
- Testing
- Orca-T, Standard-of-Care
- Where
- 19 sites in United States
- Volunteers
- 187 people
- Sponsor
- Orca Biosystems, Inc.
Vaccines, Pneumococcal Conjugate Vaccine
Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae.
- Trial name
- NCT00980655
- Testing
- 13vPnC, 23vPS
- Where
- 47 sites in United States, Belgium and 8 more
- Volunteers
- 251 people
- Sponsor
- Pfizer
Cytomegalovirus (CMV)-Positive Recipients, Allogeneic, Hematopoietic Cell Transplant (HCT)
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant.
- Trial name
- HELIOS (NCT01877655)
- Testing
- ASP0113
- Where
- 83 sites in United States, Australia and 9 more
- Volunteers
- 514 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Mycoses
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor…
- Trial name
- NCT01232504
- Testing
- rhGM-CSF group, rhG-CSF+rhGM-CSF group, rhG-CSF group
- Where
- 5 sites in China
- Volunteers
- 206 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Cytomegalovirus Infections
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
- Trial name
- NCT00411645
- Testing
- maribavir
- Where
- 97 sites in United States, Belgium and 7 more
- Volunteers
- 681 people
- Sponsor
- Shire
Influenza
Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza
This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant…
- Trial name
- NCT05170009
- Testing
- Baloxavir Marboxil, Oseltamivir
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Weill Medical College of Cornell University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Adult Acute Lymphoblastic Leukemia in Remission
Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Hodgkin Lymphoma
- Trial name
- NCT02396134
- Testing
- CMVpp65-A*0201 peptide vaccine, Laboratory Biomarker Analysis
- Where
- 5 sites in United States
- Volunteers
- 61 people
- Sponsor
- City of Hope Medical Center
Cytomegalovirus Infection
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks.
- Trial name
- NCT00942305
- Testing
- Brincidofovir
- Where
- 26 sites in United States
- Volunteers
- 239 people
- Sponsor
- Jazz Pharmaceuticals