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)
NCT05673876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-05-28
Summary
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).
Conditions
- Acute Graft-versus-host Disease
Interventions
- DRUG
-
GDC-8264
GDC-8264 tablets will be administered as per the schedule specified in the respective arms.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-06
- Primary Completion
- 2024-01-15
- Completion
- 2024-01-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant
NCT06315309 ·Status: RECRUITING ·Phase: PHASE2
-
Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD
NCT05621759 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT
NCT02876679 ·Status: COMPLETED ·Phase: PHASE2
-
Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant
NCT02684162 ·Status: COMPLETED ·Phase: PHASE2
-
Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
NCT06926595 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
NCT04539470 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics-based Mycophenolate Mofetil Dosing for GVHD Prevention
NCT01487577 ·Status: COMPLETED ·Phase: PHASE2
-
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis
NCT06001385 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation
NCT03602898 ·Status: WITHDRAWN ·Phase: PHASE2
-
Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
NCT06462365 ·Status: RECRUITING ·Phase: PHASE1
-
Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
NCT03842696 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
NCT00001529 ·Status: RECRUITING
-
Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
NCT06839456 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
NCT03970096 ·Status: RECRUITING ·Phase: PHASE2
-
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
NCT03128359 ·Status: COMPLETED ·Phase: PHASE2
-
Granulocyte Colony-stimulating Factor (G-CSF) Plus or Minus AMD3100 for Engraftment Post Allogeneic Transplant
NCT01026987 ·Status: COMPLETED ·Phase: PHASE1
-
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)
NCT02663622 ·Status: COMPLETED ·Phase: PHASE2
-
Methotrexate and Glucocorticoids in Treating Patients With Newly Diagnosed Acute Graft-Versus-Host Disease After Donor Stem Cell Transplant
NCT00357084 ·Status: COMPLETED ·Phase: PHASE2
-
A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies
NCT05796570 ·Status: RECRUITING ·Phase: PHASE2
-
Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
NCT00096096 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
NCT00004255 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT
NCT02627573 ·Status: TERMINATED ·Phase: PHASE2
-
Vorinostat to Prevent Graft Versus Host Disease Following Reduced Intensity, Related Donor Stem Cell Transplant
NCT00810602 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
NCT03246906 ·Status: TERMINATED ·Phase: PHASE2
-
Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant
NCT01754389 ·Status: COMPLETED ·Phase: PHASE2