Clinical trials: Allogeneic Hematopoietic Cell Transplant
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 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.
Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
- Conditions
- Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
- Trial name
- NCT04554914
- Testing
- Tabelecleucel
- Where
- 40 sites in United States, Austria and 5 more
- Volunteers
- 190 people
- Sponsor
- Pierre Fabre Medicament
Acute Myeloid Leukemia
Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.
The primary purpose of this study was to test the hypothesis that preemptive treatment with sabatolimab, alone or in combination with azacitidine, when administered to participants with Acute myeloid leukemia (AML)/secondary AML…
- Trial name
- NCT04623216
- Testing
- Sabatolimab, Azacitidine
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
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.
Adenovirus Infection, BK Virus Infection
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr…
- Conditions
- Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections
- Trial name
- Prevent (NCT04693637)
- Testing
- Posoleucel (ALVR105)
- Where
- 16 sites in United States
- Volunteers
- 26 people
- Sponsor
- AlloVir
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
AML, Adult Recurrent, ALL, Recurrent, Adult
BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
The goal of this clinical trial is to test BSB-1001 which is a new type of cellular therapy to treat blood cancers (AML, ALL and MDS).
- Conditions
- AML, Adult Recurrent, ALL, Recurrent, Adult, MDS
- Trial name
- NCT06704152
- Testing
- SOC + BSB-1001 Dose Escalation Cohort, SOC+BSB-1001 Expansion Dose
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BlueSphere Bio, Inc
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
Chronic Graft-Versus-Host Disease (cGVHD)
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD.
- Trial name
- NCT06619561
- Testing
- Vimseltinib
- Where
- 26 sites in United States
- Volunteers
- 48 people
- Sponsor
- Deciphera Pharmaceuticals, LLC
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.
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
Adenovirus Infections
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia.
- Trial name
- ENOVIA (NCT07387367)
- Testing
- cidofovir, Brincidofovir
- Where
- 81 sites in United States, Austria and 11 more
- Volunteers
- 180 people
- Sponsor
- SymBio Pharmaceuticals
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
Graft vs Host Disease
A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
This study was been conducted to evaluate the safety, tolerability, and activity of belumosudil (formerly known as KD025) in adult participants with chronic graft versus host disease (cGVHD).
- Trial name
- NCT02841995
- Testing
- Belumosudil (KD025)
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- Kadmon, a Sanofi Company
Related Donors Donating PBSC to a Family Member, Healthy Donors
MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies.
- Conditions
- Related Donors Donating PBSC to a Family Member, Healthy Donors, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia
- Trial name
- NCT04762875
- Testing
- MGTA-145, Plerixafor
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Ensoma
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
Antifungal Prophylaxis of Invasive Fungal Infections
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
- Trial name
- IMPROVIT (NCT00289991)
- Testing
- Itraconazole, Vfend - voriconazole
- Where
- 49 sites in Canada, Czechia and 10 more
- Volunteers
- 489 people
- Sponsor
- Pfizer