Clinical trials: Allogeneic Stem-Cell Transplant
GVHD,Acute
Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD)
The objective of this clinical study is to demonstrate safety and feasibility of single-dose infusion of Ossium MSCs product (OSSM-001) to treat steroid refractory acute GVHD (SR-aGVHD).
- Trial name
- NCT05443464
- Testing
- OSSM-001
- Sponsor
- Ossium Health, Inc.
Acute Myeloid Leukemia
RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT
To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT
- Trial name
- NCT05858814
- Testing
- RC1012 injection (allo-DNT cells)
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Guangdong Ruishun Biotech Co., Ltd
Hematologic Malignancies
Efficacy Study of a TXA127 to Reduce Graft-vs-Host Disease in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing allogeneic peripheral blood stem cell transplantation…
- Trial name
- NCT01882387
- Testing
- TXA127
- Where
- 2 sites in United States
- Sponsor
- Tarix Pharmaceuticals
Hematologic Malignancy, Acute Leukemia
Study to Characterize Mismatched to Fully HLA-Matched Ossium HPC, Marrow and Living Donor Transplantation in Patients With Hematologic Malignancies
Prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies.
- Conditions
- Hematologic Malignancy, Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT07710781
- Testing
- Ossium HPC, Marrow, Standard of care living donor - Haplo Related, Standard of care living donor - Mismatched Unrelated
- Volunteers
- 300 people
- Sponsor
- Ossium Health, Inc.
Leukemia, Myeloid, Acute
A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML)
The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy after treatment with an allogeneic stem cell transplant.
- Trial name
- NCT01468467
- Testing
- AC220
- Where
- 5 sites in United States
- Volunteers
- 13 people
- Sponsor
- Daiichi Sankyo
Poor Graft Function
Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function
The purpose of this study was to evaluate the efficacy of eltrombopag for poor graft function (PGF) on overall hematologic response (partial and complete), as determined by platelet, hemoglobin and neutrophil counts by 16 weeks…
- Trial name
- ELTION (NCT03718533)
- Testing
- Eltrombopag
- Where
- 7 sites in Spain
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
BKV Infection, EBV Infection
Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after…
- Conditions
- BKV Infection, EBV Infection, CMV Infection
- Trial name
- NCT07670468
- Testing
- LB-DTK-MV
- Where
- South Korea
- Volunteers
- 27 people
- Sponsor
- LucasBio
Leukemia
A Study of Eritoran (E5564) Administered IV Over 14 Days Prior to and During Bone Marrow Engraftment in BMT Patients Who Have Received Myeloablative Conditioning Treatment and Are Receiving Bone Marrow or Stem Cells From Matched Related Donors
This is a study designed to assess the safety of administration of up to 3 dose levels of eritoran in subjects undergoing or scheduled to undergo allogeneic bone marrow transplant (BMT).
- Trial name
- NCT00756912
- Testing
- E5564
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Eisai Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)
This randomized allogeneic transplantation protocol compares i.v. Treosulfan-based conditioning therapy with reduced intensity i.v.
- Trial name
- NCT00822393
- Testing
- Busulfan, Treosulfan
- Where
- 33 sites in Finland, France and 4 more
- Volunteers
- 570 people
- Sponsor
- medac GmbH
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
Graft-versus-host Disease (GVHD)
An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored…
- Trial name
- NCT03147742
- Testing
- Ruxolitinib
- Where
- 33 sites in United States
- Sponsor
- Incyte Corporation
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity…
- Trial name
- ALLOHA-2 (NCT07702578)
- Testing
- TSC-101, Control
- Where
- 26 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, Inc.
Acute Myeloid Leukemia (AML), Cancer
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when…
- Trial name
- VIALE-T (NCT04161885)
- Testing
- Venetoclax, Azacitidine, Best Supportive Care (BSC)
- Where
- 165 sites in United States, Australia and 16 more
- Volunteers
- 465 people
- Sponsor
- AbbVie
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
Cytomegalovirus (CMV) Infection
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age…
- Trial name
- NCT03940586
- Testing
- Letermovir oral granules, Letermovir tablet, Letermovir intravenous
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 65 people
- Sponsor
- Merck Sharp & Dohme LLC
For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling
A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs
This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person).
- Conditions
- For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling, For Recipients, Acute Myelogenous Leukemia (AML)
- Trial name
- NCT02200380
- Testing
- CDX-301, CDX-301 and plerixafor
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Celldex Therapeutics
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
HA-1H TCR T Cell for Relapsed/Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplantation
This is a non-randomised, open-label phase I study of an investigational medicinal product (IMP) consisting of a HLA-A*02:01 restricted HA-1H T cell receptor transduced T cell (MDG1021) immunotherapy for relapsed or persistent…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders
- Trial name
- NCT04464889
- Testing
- MDG1021 dose 1, MDG1021 dose 2, MDG1021 dose 3
- Where
- Netherlands
- Sponsor
- Medigene AG
ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia)
PRAISE-IR Versus CIBMTR Controls
The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- Trial name
- NCT07717164
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Miltenyi Biomedicine GmbH
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.
Allogeneic Hematopoietic Stem Cell Transplantation
Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT
The purpose of this study is to assess the initial tolerability, safety and recommended phase 2 dose of vedolizumab intravenous (IV) administered for GvHD prophylaxis along with standard GvHD prophylaxis therapy (in participants…
- Trial name
- NCT02728895
- Testing
- Vedolizumab
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Takeda