Clinical trials: Recipients of Allogeneic Stem Cell Transplantation
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.
Highly Sensitized Prospective Kidney Transplant Recipients
Carfilzomib and Belatacept for Desensitization
Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors.
- Trial name
- ADAPT (NCT05017545)
- Testing
- carfilzomib, belatacept, Bone marrow aspiration
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Myeloid Leukemia, Myelodysplastic Syndrome
Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation
Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment for hematological abnormalities. Poor graft function, occurs when there poor donor engraftment.
- Conditions
- Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Trial name
- NCT02258490
- Testing
- G-CSF mobilized CD34+ selected cells for transplantation
- Where
- United States
- Sponsor
- Emory University
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Acute Lymphoblastic Leukemia
- Trial name
- NCT03802695
- Testing
- OrcaGraft (Orca-Q)
- Where
- 12 sites in United States
- Volunteers
- 300 people
- Sponsor
- Orca Biosystems, Inc.
Immunocompromised Patients
Immunogenicity and Safety of Two Respiratory Syncytial Virus Vaccine Strategies in Lung and Allogeneic Haematopoietic Stem Cell Transplant Recipients.
Respiratory syncytial virus (RSV) is a major cause of acute respiratory infections (ARIs), which occur in seasonal outbreaks. Among the adult population, immunocompromised individuals, particularly lung transplant recipients and…
- Trial name
- RSVAxID (NCT07863401)
- Testing
- RSVpreF3-AS01, RSVpreF3
- Where
- 16 sites in France
- Volunteers
- 400 people
- Sponsor
- Hospices Civils de Lyon
Allogeneic Hematopoietic Stem Cell
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.
- Trial name
- NCT02269150
- Testing
- fecal microbiota transplantation (FMT), No fecal microbiota transplantation (FMT), routine management
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Memorial Sloan Kettering Cancer 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
Lymphoid Leukemia, Myeloid Leukemia
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
- Conditions
- Lymphoid Leukemia, Myeloid Leukemia, Monocytic Leukemia, Myelodysplasia
- Trial name
- NCT03613727
- Testing
- Intravenous (IV) and oral Vitamin C
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Virginia Commonwealth University
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
Haematological Malignancies, CMV Infection
Study of Adoptive Immunotherapy With Donor-derived CMV-specific T Cells for Recipients of Allo-HSCT
The study will test the hypothesis that CMV TCR-transduced T cells, at a specific T-cell dose/kg, can generate a functional CMV immune response post-transplant, where CMV-specific donor T cells cannot be isolated by conventional…
- Trial name
- CMV_TCR-001 (NCT02988258)
- Testing
- CMV-TCR transduced donor-derived T cells
- Where
- 4 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- University College, London
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
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Precision-T: A 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, Myelodysplastic Syndromes, Acute Leukemia
- Trial name
- NCT04013685
- Testing
- Orca-T
- Where
- 21 sites in United States
- Volunteers
- 155 people
- Sponsor
- Orca Biosystems, Inc.
Cancer
Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant
RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.
- Trial name
- NCT00110045
- Testing
- caspofungin acetate
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 171 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant, Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics
SYN-004 Safety and Tolerability in Allo-HCT Subjects
Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER)…
- Trial name
- NCT04692181
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Theriva Biologics, Inc.
Stem Cell Transplantation, Fatigue
Severe Fatigue in Stem Cell Transplantation
Fatigue is a common symptom during allogeneic-hematopoietic stem cell transplantation (allo-HSCT). However, effects of severe fatigue on pulmonary functions, blood cells, dyspnea, muscle strength, exercise capacity, depression…
- Trial name
- NCT03448471
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people
- Sponsor
- Gazi University
Graft Failure
Fludarabine and 400 CGY Total Body Irradiation for Recipients of HLA-Matched or Mis-Matched Family or Unrelated Donor Hematopoietic Stem Cell Transplants Who Have Rejected Their First Allogeneic Stem Cell Transplant
Major Objectives A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients who have rejected (<5% T Cell Chimerism) a previous allogeneic hematopoietic stem cell graft by using an…
- Trial name
- NCT00472329
- Testing
- Allogeneic hematopoietic stem cell graft using an allogeneic SCT HLA-Identical or non-identical family donor or unrelated donors, fludarabine, TBI
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Colorado Blood Cancer Institute
Stem Cell Transplantation
Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation
The primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (GVHD) in recipients of mismatched…
- Trial name
- NCT00612274
- Testing
- tacrolimus, Sirolimus, Methotrexate
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Yale University
Bone Marrow Transplant
Pneumonia Vaccine in Bone Marrow Transplant Recipients: Usefulness of Donor Vaccination
Streptococcus pneumoniae, also known as Pneumococcus, is a common cause of pneumonia in transplant patients. There has been a vaccine available for this infection called Pneumovax.
- Trial name
- NCT00143780
- Testing
- The polysaccharide vaccine used is Pneumovax (Merck vaccines), The conjugate vaccine used is Prevnar (Wyeth-Ayerst vaccines)
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- University Health Network, Toronto
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
Cytomegalovirus Infection
A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)
The purpose of this study is to evaluate the efficacy and safety of a once-a-day oral or intravenous (IV) dose of Letermovir (MK-8228) in Chinese adult hematopoietic stem cell transplant (HSCT) recipients for the prevention of…
- Trial name
- NCT05763823
- Testing
- Letermovir
- Where
- 21 sites in China
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC