10 completed, 3 terminated, 1 active not recruiting, 1 unknown. 16 Phase 2, 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 10, Terminated 3, Active not recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 1, Unknown 1 |
Follow Advagraf: new trials by email Literature Review of Advagraf trials Research Report on Advagraf
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation Tacrolimus, Tacrolimus (Tacrolimus elimination), Sirolimus - Liver Transplantation | Phase 2 / Phase 3 | Unknown | Southern Medical University, China | 130 | 2018-05-01 | 2018-04-18 |
| Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies Total-body irradiation, Donor lymphocytes infusion (DLI), Cyclophosphamide - Malignant Neoplasm | Phase 2 | Terminated | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 4 | 2013-05-17 | 2025-05-16 |
| A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time Tacrolimus, Tacrolimus prolonged release - Heart Transplantation, Kidney Transplantation | Phase 2 | Completed | Astellas Pharma Europe Ltd. | 44 | 2012-04-03 | 2024-11-01 |
| A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives Total Body Irradiation (TBI), Donor Lymphocyte Infusion (DLI), Cyclophosphamide (CY) - Hematologic Malignancy, Leukemia | Phase 2 | Terminated | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 4 | 2012-03-01 | 2025-05-04 |
| Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf® Advagraf, Prograf - Heart Transplantation, Lung Transplantation | Phase 2 | Completed | Astellas Pharma Inc | 17 | 2011-07-01 | 2015-06-16 |
| Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients tacrolimus - Kidney Transplantation, Pediatric Patients | Phase 2 / Phase 3 | Completed | Seoul National University Hospital | 2011-07-01 | 2015-05-27 | |
| Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® Tacrolimus, Tacrolimus prolonged release - Intestine Transplantation, Kidney Transplantation | Phase 2 | Completed | Astellas Pharma Europe Ltd. | 81 | 2011-05-25 | 2026-10-19 |
| Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies Total Body Irradiation, Donor Lymphocyte Infusion (DLI), Cyclophosphamide - Hematologic Malignancy | Phase 2 | Completed | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 25 | 2010-05-01 | 2025-04-30 |
| Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD Fludarabine Phosphate, Tacrolimus, Thiotepa - Graft Versus Host Disease, Leukemia | Phase 2 | Terminated | Fred Hutchinson Cancer Center | 41 | 2009-12-17 | 2020-08-20 |
| Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma Stem cell infusion, TLI, Anti-thymocyte globulin - Lymphoma, Non-Hodgkin | Phase 2 | Active not recruiting | Washington University School of Medicine | 18 | 2009-05-05 | 2026-02-02 |
| Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation Tacrolimus (TAC), Methotrexate (MTX), Rapamycin (RAPA) - Acute Graft Versus Host Disease | Phase 2 | Completed | H. Lee Moffitt Cancer Center and Research Institute | 74 | 2008-09-01 | 2015-07-31 |
| Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer beclomethasone dipropionate, placebo, tacrolimus - Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia | Phase 2 | Completed | Fred Hutchinson Cancer Center | 140 | 2007-04-01 | 2021-02-03 |
| A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative Total Body Irradiation (TBI), Donor Lymphocyte Infusion (DLI), Cyclophosphamide (CY) - Hematologic Malignancies | Phase 1 / Phase 2 | Completed | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 27 | 2006-01-01 | 2025-05-04 |
| Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer Fludarabine Phosphate, Total-Body Irradiation, Peripheral Blood Stem Cell Transplantation - Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndrome | Phase 2 | Completed | Fred Hutchinson Cancer Center | 210 | 2004-11-01 | 2019-10-30 |
| A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients Tacrolimus Modified Release (MR), tacrolimus - Kidney Transplantation | Phase 2 | Completed | Astellas Pharma Inc | 70 | 2002-08-01 | 2013-09-26 |
| Bortezomib Before Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma nonmyeloablative allogeneic hematopoietic stem cell transplantation, allogeneic bone marrow transplantation, bortezomib - Multiple Myeloma, Refractory Multiple Myeloma | Phase 1 / Phase 2 | Withdrawn | Mayo Clinic | 2023-01-05 |
Hematologic Neoplasms (4) · Leukemia, Myeloid, Acute (4) · Lymphoma, Non-Hodgkin (4) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (4) · Graft vs Host Disease (3) · Hodgkin Disease (3) · Leukemia, Lymphocytic, Chronic, B-Cell (3) · Multiple Myeloma (3) · Blast Crisis (2) · Burkitt Lymphoma (2) · Congenital Abnormalities (2) · Leukemia (2) · Leukemia, Myeloid, Accelerated Phase (2) · Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative (2) · Lymphoma, B-Cell, Marginal Zone (2)
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University (4) · Fred Hutchinson Cancer Center (3) · Astellas Pharma Europe Ltd. (2) · Astellas Pharma Inc (2) · H. Lee Moffitt Cancer Center and Research Institute (1) · Mayo Clinic (1) · Seoul National University Hospital (1) · Southern Medical University, China (1) · Washington University School of Medicine (1)
United States (10) · France (3) · Italy (3) · United Kingdom (3) · Belgium (2) · Czechia (2) · Germany (2) · Poland (2) · Austria (1) · Canada (1) · China (1) · Denmark (1) · South Korea (1) · Taiwan (1)
Dolores Grosso, DNP, CRNP (3) · Neal Flomenberg, MD (3) · Brenda Sandmaier (1) · Claudio Anasetti, MD (1) · James L. Slack, M.D. (1) · Jongwon Ha, MD, PhD (1) · Kebo Zhong, M.D (1) · Keith Stockerl-Goldstein, MD (1) · Marie Bleakley, MD (1) · Martha Q. Lacy, M.D. (1) · Paul Martin (1) · Warren Shlomchik, MD (1)
PMID 21868572, PMID 22689677, PMID 25085357, PMID 26053664, PMID 32499241, PMID 35007144
P01CA018029 (2), P30CA015704 (2)