Clinical trials: Allogeneic Stem Cell Transplant
Primary Immunodeficiencies, Inborn Errors of Metabolism
Treosulfan-based Versus Busulfan-based Conditioning in Paediatric Patients With Non-malignant Diseases
The aim of the trial is to describe the safety and efficacy of intravenous (i.v.) Treosulfan compared to the conventional (myeloablative) dose of i.v.
- Conditions
- Primary Immunodeficiencies, Inborn Errors of Metabolism, Haemoglobinopathies, Bone Marrow Failure Syndromes
- Trial name
- NCT02349906
- Testing
- Treosulfan, Busilvex
- Where
- 21 sites in Czechia, Germany and 2 more
- Volunteers
- 106 people
- Sponsor
- medac GmbH
GVHD
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD
This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs.
- Trial name
- NCT05094765
- Testing
- FMT
- Volunteers
- 15 people
- Sponsor
- Shenzhen Xbiome Biotech Co., Ltd.
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
Hematopoietic Stem Cells
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in…
- Trial name
- NCT03657160
- Testing
- Vedolizumab
- Where
- 139 sites in United States, Argentina and 25 more
- Volunteers
- 343 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Metachromatic Leukodystrophy
Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis (Compassionate Use)
A subject was treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) product manufactured using the CliniMACS (Miltenyi Biotec) device, rather than the Max Sep (Baxter) device.
- Trial name
- NCT02084121
- Testing
- Enriched Hematopoetic Stem Cell Infusion
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
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
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
Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.
- Trial name
- HARBOUR (NCT03340766)
- Testing
- Blinatumomab, Pembrolizumab
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 31 people
- Sponsor
- Amgen
Multiple Sclerosis
Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis
The goal of this research study is to establish chimerism with the goal to halt disease progression in patients with Multiple Sclerosis.
- Trial name
- NCT00497952
- Testing
- hematopoetic stem cell infusion
- Sponsor
- Talaris Therapeutics Inc.
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.
Acute Myelogenous Leukemia, Myelodysplastic Syndromes
AMD3100 With Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplant for AML and MDS
AMD3100 given in combination with busulfan, fludarabine (and thymoglobulin (ATG) for unrelated or HLA nonidentical donors) preparative regimen in patients with acute myelogenous leukemia (AML) / myelodysplastic syndromes (MDS).
- Trial name
- NCT00396968
- Testing
- AMD3100, Allogeneic Stem Cell Transplantation
- Sponsor
- Genzyme, a Sanofi Company
cGVHD
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)
- Trial name
- THRIVE (NCT05919511)
- Testing
- Non-Interventional
- Where
- 37 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Incyte Corporation
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.
Fungus Diseases
PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of…
- Trial name
- NCT00326157
- Testing
- AmBisome
- Where
- Italy
- Volunteers
- 34 people
- Sponsor
- Gilead Sciences
Sickle Cell Disease, Thalassemia
Allogeneic SCT of CordIn™, in Patients With Hemoglobinopathies
CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to evaluate the safety and efficacy of CordIn™.
- Trial name
- NCT02504619
- Testing
- CordIn
- Where
- 3 sites in United States, France
- Volunteers
- 1 people
- Sponsor
- Gamida Cell ltd
Graft-versus-host Disease (GVHD)
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood…
- Trial name
- NCT06615050
- Testing
- Tacrolimus (Tac), Methotrexate (MTX), Ruxolitinib (Rux)
- Where
- 30 sites in United States
- Volunteers
- 572 people
- Sponsor
- Incyte Corporation
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.
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
Acute Leukemia
Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and…
- Trial name
- NCT00823316
- Testing
- Human umbilical cord blood-derived mesenchymal stem cells
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Medipost Co Ltd.
Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS)
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
This study aim is to assess, if treosulfan pharmacokinetics are influenced by declined renal function and by race/ethnicity of patients.
- Conditions
- Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS), Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- Trial name
- NCT05534620
- Testing
- Treosulfan, Fludarabine
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- medac GmbH