Ongoing phase 2/3 clinical trials for GvHD prophylaxis
| Trial . | Agents/approach . | Study design . | Study population . |
|---|---|---|---|
| A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-Term Dosing for GVHD Prophylaxis (ABA3) NCT04380740 | Abatacept, CNI/MTX Extending dosing of abatacept for GvHD prevention | Phase: 2 N: 160 | Disease: Malignant Recipient Age: >2 y Donor: MUD/MMUD Graft Source: PBSC or BM Conditioning: MAC/RIC |
| Acute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant (ASCENT) NCT03924401 | Abatacept, CNI/MTX Extended dosing of abatacept for GvHD prevention | Phase: 2 N: 30 | Disease: Nonmalignant Recipient Age: 0-20 y Donor: MUD/MMUD Graft Source: PBSC or BM Conditioning: MAC/RIC |
| Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GVHD NCT05621759 | PTCy, Abatacept, short-course tacrolimus | Phase: 2 N: 92 | Disease: Malignant Recipient Age: >18 y Donor: Haploidentical Graft Source: PBSC Conditioning: MAC/RIC |
| Optimizing PTCy Dose and Timing NCT03983850 | PTCy, Sirolimus, MMF Reduced-dose PTCy | Phase: 1/2 N: 400 | Disease: Malignant Recipient Age: >12 y Donor: Haploidentical Graft Source: BM or PBSC Conditioning: MAC |
| HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide (ACCESS) NCT04904588 | PTCy, Tacrolimus, MMF | Phase: 2 N: 300 | Disease: Malignant Recipient Age: >1 y Donor: MMUD Graft Source: PBSC, BM Conditioning: MAC, RIC, NMA |
| A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease NCT04202835 | ATG ± PTCy | Phase 2 N: 80 | Disease: Malignant Recipient Age: 16-70 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC, RIC |
| A Phase II Pediatric Study of GVHD Prophylaxis Regimen With No Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies NCT05579769 | CNI/MTX, Ruxolitinib ± ATG | Phase: 2 N: 32 | Disease: Malignant Recipient Age: >12 y Donor: MRD, MUD Graft Source: BM Conditioning: MAC |
| Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant NCT04022239 | Bendamustine, Tac, MMF, ± PTCy Posttransplant bendamustine | Phase: 1/2 N: 40 | Disease: Malignant Recipient Age: 18-70 y Donor: MMUD, Haploidentical Graft Source: NA Conditioning: RIC |
| Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation NCT04395222 | Tocilizumab, ± ATG Tocilizumab day −1 | Phase: 2 N: 70 | Disease: Malignant Recipient Age: >18 y Donor: Haplo Graft Source: Haplo NA + UCB Conditioning: RIC |
| Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis NCT03520647 | PTCy | Phase: 2 N: 56 | Disease: Nonmalignant Recipient Age: 4-75 y Donor: Haploidentical Graft Source: PBSC Conditioning: NA |
| The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant (MODULAATE) NCT03805789 | Alpha-1 Antitrypsin | Phase: 2/3 N: 310 | Disease: Malignant Recipient Age: >12 y Donor: MUD, MMUD Graft Source: PBSC and BM Conditioning: MAC |
| Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Stem Cell Transplantation NCT03246906 | CNI, sirolimus ± MMF, ± PTCy | Phase: 2 N: 160 | Disease: Malignant Recipient Age: >18 y Donor: MUD, MMUD Graft Source: PBSC Conditioning: NMA, RIC |
| GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG (GRAPPA) NCT05153226 | PTCy Or ATG | Phase: 3 N: 540 | Disease: Malignant Recipient Age: >18 y Donor: Haploidentical Graft Source: PBSC Conditioning: NA |
| High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT) Study NCT05289167 | PTCy, Bortezomib, Abatacept ± ATG | Phase: 1/2 N: 74 | Disease: Malignant Recipient Age: >18 y Donor: MRD, MUD, MMUD Graft Source: PBSC Conditioning: NA |
| Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease NCT04112810 | Tildrakizumab (anti–IL-23 antibody), CNI/MTX | Phase: 2 N: 55 | Disease: Malignant Recipient Age: >18 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC |
| Ustekinumab for the Prevention of Acute Graft-Versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant NCT04572815 | Ustekinumab | Phase: 2 N: 116 | Disease: Malignant Recipient Age: 18-70 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC, RIC |
| Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants NCT05364762 | Itacitinib, PTCy, and Tacrolimus | Phase: 2 N: 50 | Disease: Malignant Recipient Age: 0-80 y Donor: MRD, MUD Graft Source: PBSC Conditioning: RIC |
| The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation NCT05436418 | PTCy, Sirolimus, MMF Reduced dose PTCy | Phase: 1/2 N: 220 | Disease: Malignant Recipient Age: >12 y Donor: Haploidentical, MRD, MUD Graft Source: PBSC Conditioning: RIC |
| Vorinostat for GVHD Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation NCT03842696 | Vorinostat, CNI, MTX, ± PTCy | Phase: 1/2 N: 49 | Disease: Malignant Recipient Age: 3-39 y Donor: Haploidentical, MRD, MUD Graft Source: PBSC, BM Conditioning: MAC/RIC |
| PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation NCT05120570 | PTCy, sirolimus combined with VIC-1911 (Aurora Kinase A inhibitor) | Phase: 1/2 N: 75 | Disease: Malignant Recipient Age: >18 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC |
| High Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis (ATG2017) NCT03456817 | ATG, CSA, MTX High-dose ATG with low-dose CSA | Phase: 2 N: 200 | Disease: Malignant Recipient Age: >18 y Donor: MSD, MUD, MMUD Graft Source: PBSC Conditioning: MAC |
| Naive T Cell Depletion for Preventing Chronic Graft-Versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant NCT03779854 | Naive T-cell depletion, CNI/MTX | Phase: 2 N: 68 | Disease: Malignant Recipient Age: 6 mo to 22 y Donor: MRD, MUD Graft Source: PBSC, BM Conditioning: MAC |
| Trial . | Agents/approach . | Study design . | Study population . |
|---|---|---|---|
| A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-Term Dosing for GVHD Prophylaxis (ABA3) NCT04380740 | Abatacept, CNI/MTX Extending dosing of abatacept for GvHD prevention | Phase: 2 N: 160 | Disease: Malignant Recipient Age: >2 y Donor: MUD/MMUD Graft Source: PBSC or BM Conditioning: MAC/RIC |
| Acute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant (ASCENT) NCT03924401 | Abatacept, CNI/MTX Extended dosing of abatacept for GvHD prevention | Phase: 2 N: 30 | Disease: Nonmalignant Recipient Age: 0-20 y Donor: MUD/MMUD Graft Source: PBSC or BM Conditioning: MAC/RIC |
| Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GVHD NCT05621759 | PTCy, Abatacept, short-course tacrolimus | Phase: 2 N: 92 | Disease: Malignant Recipient Age: >18 y Donor: Haploidentical Graft Source: PBSC Conditioning: MAC/RIC |
| Optimizing PTCy Dose and Timing NCT03983850 | PTCy, Sirolimus, MMF Reduced-dose PTCy | Phase: 1/2 N: 400 | Disease: Malignant Recipient Age: >12 y Donor: Haploidentical Graft Source: BM or PBSC Conditioning: MAC |
| HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide (ACCESS) NCT04904588 | PTCy, Tacrolimus, MMF | Phase: 2 N: 300 | Disease: Malignant Recipient Age: >1 y Donor: MMUD Graft Source: PBSC, BM Conditioning: MAC, RIC, NMA |
| A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease NCT04202835 | ATG ± PTCy | Phase 2 N: 80 | Disease: Malignant Recipient Age: 16-70 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC, RIC |
| A Phase II Pediatric Study of GVHD Prophylaxis Regimen With No Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies NCT05579769 | CNI/MTX, Ruxolitinib ± ATG | Phase: 2 N: 32 | Disease: Malignant Recipient Age: >12 y Donor: MRD, MUD Graft Source: BM Conditioning: MAC |
| Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant NCT04022239 | Bendamustine, Tac, MMF, ± PTCy Posttransplant bendamustine | Phase: 1/2 N: 40 | Disease: Malignant Recipient Age: 18-70 y Donor: MMUD, Haploidentical Graft Source: NA Conditioning: RIC |
| Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation NCT04395222 | Tocilizumab, ± ATG Tocilizumab day −1 | Phase: 2 N: 70 | Disease: Malignant Recipient Age: >18 y Donor: Haplo Graft Source: Haplo NA + UCB Conditioning: RIC |
| Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis NCT03520647 | PTCy | Phase: 2 N: 56 | Disease: Nonmalignant Recipient Age: 4-75 y Donor: Haploidentical Graft Source: PBSC Conditioning: NA |
| The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant (MODULAATE) NCT03805789 | Alpha-1 Antitrypsin | Phase: 2/3 N: 310 | Disease: Malignant Recipient Age: >12 y Donor: MUD, MMUD Graft Source: PBSC and BM Conditioning: MAC |
| Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Stem Cell Transplantation NCT03246906 | CNI, sirolimus ± MMF, ± PTCy | Phase: 2 N: 160 | Disease: Malignant Recipient Age: >18 y Donor: MUD, MMUD Graft Source: PBSC Conditioning: NMA, RIC |
| GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG (GRAPPA) NCT05153226 | PTCy Or ATG | Phase: 3 N: 540 | Disease: Malignant Recipient Age: >18 y Donor: Haploidentical Graft Source: PBSC Conditioning: NA |
| High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT) Study NCT05289167 | PTCy, Bortezomib, Abatacept ± ATG | Phase: 1/2 N: 74 | Disease: Malignant Recipient Age: >18 y Donor: MRD, MUD, MMUD Graft Source: PBSC Conditioning: NA |
| Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease NCT04112810 | Tildrakizumab (anti–IL-23 antibody), CNI/MTX | Phase: 2 N: 55 | Disease: Malignant Recipient Age: >18 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC |
| Ustekinumab for the Prevention of Acute Graft-Versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant NCT04572815 | Ustekinumab | Phase: 2 N: 116 | Disease: Malignant Recipient Age: 18-70 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC, RIC |
| Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants NCT05364762 | Itacitinib, PTCy, and Tacrolimus | Phase: 2 N: 50 | Disease: Malignant Recipient Age: 0-80 y Donor: MRD, MUD Graft Source: PBSC Conditioning: RIC |
| The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation NCT05436418 | PTCy, Sirolimus, MMF Reduced dose PTCy | Phase: 1/2 N: 220 | Disease: Malignant Recipient Age: >12 y Donor: Haploidentical, MRD, MUD Graft Source: PBSC Conditioning: RIC |
| Vorinostat for GVHD Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation NCT03842696 | Vorinostat, CNI, MTX, ± PTCy | Phase: 1/2 N: 49 | Disease: Malignant Recipient Age: 3-39 y Donor: Haploidentical, MRD, MUD Graft Source: PBSC, BM Conditioning: MAC/RIC |
| PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation NCT05120570 | PTCy, sirolimus combined with VIC-1911 (Aurora Kinase A inhibitor) | Phase: 1/2 N: 75 | Disease: Malignant Recipient Age: >18 y Donor: MRD, MUD Graft Source: PBSC Conditioning: MAC |
| High Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis (ATG2017) NCT03456817 | ATG, CSA, MTX High-dose ATG with low-dose CSA | Phase: 2 N: 200 | Disease: Malignant Recipient Age: >18 y Donor: MSD, MUD, MMUD Graft Source: PBSC Conditioning: MAC |
| Naive T Cell Depletion for Preventing Chronic Graft-Versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant NCT03779854 | Naive T-cell depletion, CNI/MTX | Phase: 2 N: 68 | Disease: Malignant Recipient Age: 6 mo to 22 y Donor: MRD, MUD Graft Source: PBSC, BM Conditioning: MAC |
Study agent/approach in bold.
Noncomprehensive list of actively recruiting trials extracted from ClinicalTrials.gov.
UCB, umbilical cord blood.