Clinical trials: Allogeneic Hematopoietic Cell Transplant
Acute GvHD
Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further…
- Trial name
- ALD518-010 (NCT01530256)
- Testing
- ALD518
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Graft vs Host Disease
Safety and Efficacy Study of T-Guard to Treat Steroid-resistant Acute GVHD
In this study, a combination of two antibodies both conjugated to a cell-killing toxin (so-called immunotoxins) will be evaluated.
- Trial name
- NCT02027805
- Testing
- T-Guard
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 20 people
- Sponsor
- Xenikos
Graft Versus Host Disease
Study of Opebacan in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
The objectives of this study are as follows: To demonstrate the safety of escalating doses of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantation To determine the pharmacokinetics of…
- Trial name
- HSCT (NCT00454155)
- Testing
- Opebacan
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- XOMA (US) LLC
Hematological Malignancies
Dose-range Finding Treosulfan-based Conditioning
Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological…
- Trial name
- NCT01063647
- Testing
- Treosulfan
- Where
- 7 sites in Finland, Germany and 2 more
- Volunteers
- 56 people
- Sponsor
- medac GmbH
Leukemia, Myeloid, Acute
A Long-term Follow-up Study of Patients Who Received VOR33
VOR33 long-term follow-up (LTFU) study
- Trial name
- NCT05309733
- Testing
- VOR33
- Where
- 11 sites in United States, Canada
- Volunteers
- 10 people
- Sponsor
- Vor Biopharma
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.
Acute Myeloid Leukemia
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
- Trial name
- RADIUS (NCT01883362)
- Testing
- Midostaurin, Standard of Care
- Where
- 19 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Novartis 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
Allogeneic Hematopoietic Stem Cell Transplantation
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal…
- Trial name
- NCT02993783
- Testing
- Vedolizumab
- Where
- 15 sites in United States, Belgium and 3 more
- Volunteers
- 17 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation
Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002)
This is a multicenter prospective phase IIa dose escalation and phase IIa expansion cohort clinical trial designed to evaluate the safety and tolerability of efprezimod alfa for acute GVHD prophylaxis.
- Conditions
- Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation, Leukemia
- Trial name
- NCT02663622
- Testing
- Efprezimod alfa, Methotrexate, Tacrolimus
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Infectious Complications Following HSCT
Registry on Salvage Antiviral Treatment for Patients Experiencing ADV and / or CMV Reactivation Post Allogeneic HSCT
DESIGN: Disease registry - non-interventional. INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.
- Trial name
- EPROS (NCT02873325)
- Testing
- antiviral therapies for CMV and/or ADV
- Where
- 2 sites in United Kingdom
- Volunteers
- 1 people
- Sponsor
- Cell Medica Ltd
BK Virus Infection, Hemorrhagic Cystitis
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).
- Trial name
- NCT04390113
- Testing
- Posoleucel (ALVR105)
- Where
- 56 sites in United States, France and 5 more
- Volunteers
- 97 people
- Sponsor
- AlloVir
Allogenic Stem Cell Transplantation
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
This is a multicenter, parallel multicohort, phase 2, single-arm study for adjunctive treatment in participants with high-risk myeloid malignancies undergoing allogeneic HSCT.
- Trial name
- NCT05726682
- Testing
- SAR445419
- Sponsor
- Sanofi
Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and…
- Conditions
- Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma
- Trial name
- NCT00285259
- Testing
- VCL-CB01, Phosphate-buffered Saline (PBS)
- Where
- 22 sites in United States
- Volunteers
- 112 people
- Sponsor
- Astellas Pharma Inc
Graft Vs Host Disease
Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)
To establish the safety and efficacy of two dose levels of ex-vivo cultured adult human mesenchymal stem cells (hMSCs) (Prochymal®) in participants experiencing acute GVHD, Grades II-IV, post hematopoietic stem cells (HSC)…
- Trial name
- NCT00136903
- Testing
- Prochymal® - 2 Million cells/kg, Prochymal®- 8 Million cells/kg, Methylprednisolone
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- Mesoblast, Inc.
Hematological Malignancies
Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell…
- Trial name
- NCT04959903
- Testing
- Allogeneic T cell progenitors, cultured ex-vivo
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Smart Immune SAS
MPS-IH (Hurler Syndrome)
A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects With MPS-IH Compared With Standard of Care With Allogeneic HSCT
A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).
- Trial name
- HURCULES (NCT06149403)
- Testing
- Experimental: OTL-203, Active Comparator: Allo-HSCT
- Where
- 5 sites in United States, Italy and 2 more
- Volunteers
- 41 people
- Sponsor
- Orchard Therapeutics
Graft Versus Host Disease
Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)
The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation…
- Trial name
- NCT01379209
- Testing
- RGI-2001, Calcineurin Inhibitors, Allogeneic Hematopoietic Stem Cell Transplantation
- Where
- 6 sites in United States
- Volunteers
- 68 people
- Sponsor
- Regimmune Corporation
Acute Myeloid Leukemia, Leukemia, Acute Myeloid
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus…
- Conditions
- Acute Myeloid Leukemia, Leukemia, Acute Myeloid, Myeloid Leukemia, Acute, Leukemia, Myeloid, Acute
- Trial name
- SIERRA (NCT02665065)
- Testing
- Iomab-B, Conventional Care, HCT
- Where
- 24 sites in United States, Canada
- Volunteers
- 153 people
- Sponsor
- Actinium Pharmaceuticals
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