Clinical trials: Allogeneic Stem-Cell Transplant
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
GVHD, Adult Acute Myeloid Leukemia
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.
- Conditions
- GVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT01295710
- Testing
- US-ATG-F
- Where
- 28 sites in United States, Australia
- Volunteers
- 260 people
- Sponsor
- Neovii Biotech
Hematopoietic Stem Cell Transplantation, Acute Graft Versus Host Disease
Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)
The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate.
- Conditions
- Hematopoietic Stem Cell Transplantation, Acute Graft Versus Host Disease, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- Trial name
- CATHY (NCT04095858)
- Testing
- Efprezimod alfa, Methotrexate, Tacrolimus
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Graft Failure
Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.
This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF.
- Trial name
- NCT04731298
- Testing
- Emapalumab
- Where
- 5 sites in Australia, Canada and 1 more
- Volunteers
- 2 people
- Sponsor
- Swedish Orphan Biovitrum
Acute Graft-versus-host Disease
A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)
The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).
- Trial name
- NCT05673876
- Testing
- GDC-8264
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Genentech, Inc.
Iron Overload
Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload
This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT).
- Trial name
- NCT01335035
- Testing
- deferasirox
- Where
- 9 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Allogeneic Stem Cell Transplantation
Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation.
- Trial name
- CONVINCE (NCT01185223)
- Testing
- Valganciclovir, Ganciclovir
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 212 people
- Sponsor
- Pierrel Research Europe GmbH
Acute Myeloid Leukemia, Relapsed, Adult
A Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Very Low-dose Cytarabine in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Phase I, open label, non-randomized, multicenter, prospective dose escalation study of F16IL2 in combination with very low-dose cytarabine in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell…
- Trial name
- NCT02957032
- Testing
- F16IL2, cytarabine
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Philogen S.p.A.
Acute Myeloid Leukemia
Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients
This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3 mutations who have achieved complete remission (CR) after allogeneic stem cell transplantation.
- Trial name
- NCT02400255
- Testing
- Crenolanib besylate
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Arog Pharmaceuticals, Inc.
Acute Graft-versus-host Disease
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Efmarodocokin Alfa and to make a preliminary assessment of activity of Efmarodocokin Alfa in…
- Trial name
- NCT04539470
- Testing
- Efmarodocokin Alfa
- Where
- 8 sites in United States
- Volunteers
- 18 people
- Sponsor
- Genentech, Inc.
AML/MDS
Study of Mana 312 (Multi Tumor-Associated Antigen T Cells) in Adults With AML/MDS After HSCT
This is a Phase 1, open-label, non-randomized, single and multiple dose escalation study designed to evaluate the safety and preliminary efficacy of administering Mana 312 to subjects with AML/MDS after allogeneic HSCT.
- Trial name
- NCT04679194
- Testing
- Mana 312
- Where
- 8 sites in United States
- Volunteers
- 11 people
- Sponsor
- Mana Therapeutics
Cytomegalovirus Infection
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.
The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV…
- Trial name
- NCT05683457
- Testing
- mRNA-1647
- Where
- 3 sites in United States
- Volunteers
- 84 people
- Sponsor
- ModernaTX, Inc.
Chronic Ocular Graft-versus-host Disease
Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.
To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.
- Trial name
- NCT03990051
- Testing
- Pro-ocular™ topical gel
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Glia, LLC
Leukemia/Lymphoma, Cutaneous T Cell Lymphoma
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until…
- Conditions
- Leukemia/Lymphoma, Cutaneous T Cell Lymphoma, ATLL
- Trial name
- NCT04014374
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Kyowa Kirin, Inc.
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
Graft vs Host Disease
Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant
This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children…
- Trial name
- REACH 5 (NCT03774082)
- Testing
- INC424
- Where
- 21 sites in Brazil, Canada and 12 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Graft Vs Host Disease
A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation
This is a Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients with Acute Myeloid Leukemia (AML) or…
- Trial name
- GVHD (NCT02737306)
- Testing
- PRO 140
- Where
- 8 sites in United States
- Volunteers
- 11 people
- Sponsor
- CytoDyn, Inc.
Acute Lymphoblastic Leukemia, Leukemia, Acute Myeloid (AML), Child
Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant
This study will evaluate pediatric patients with malignant or non-malignant blood cell disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa and beta cells that comes from a partially…
- Conditions
- Acute Lymphoblastic Leukemia, Leukemia, Acute Myeloid (AML), Child, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes
- Trial name
- NCT03301168
- Testing
- BPX-501 T cells, Rimiducid
- Where
- 10 sites in United States
- Volunteers
- 120 people
- Sponsor
- Bellicum Pharmaceuticals
Acute Graft Versus Host Disease
A Study of AbGn-168H in Patients With Steroid Refractory Acute Graft-vs-Host Disease After Donor Stem Cell Transplant
This study is to establish the safety, determine if there is an improvement in steroid refractory acute graft-vs-host disease (aGvHD) compared to historical cohorts, and determine the changes of aGvHD-associated T-cell clones in…
- Trial name
- NCT02436460
- Testing
- AbGn-168H
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- AbGenomics B.V Taiwan Branch
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