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Label indication VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of: • Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation… FDA label
Also known as Thymoglobulin [Anti-thymocyte Globulin (rabbit)], Vidaza, anti-thymocyte globulin (rabbit), ATG, Genzyme, anti-thymocyte globulin, Rabbit, Rabbit-ATG
thymoglobulin · 6 trials · 19 indications
The composite endpoint components and definitions are: * Fever: Body temperature ≥ 38.5˚C. * Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors. * Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for \> 12 hours out of a 24 hour period. * Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia) * Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation
A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).
| Arm | Type | Description |
|---|---|---|
| Single-dose Thymoglobulin | EXPERIMENTAL | Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion |
| Divided-dose Thymoglobulin | ACTIVE_COMPARATOR | Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 |
| ATG 1.7 mg/kg, TBI, transplant | EXPERIMENTAL | (Rabbit-ATG;Thymoglobulin,Genzyme) ATG 5.1 mg/kg in three divided doses (1.7 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive lower dose anti-thymocyte globulin IV on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30. |
| ATG 2.5 mg/kg/d, TBI, transplant | EXPERIMENTAL | (Rabbit-ATG;Thymoglobulin,Genzyme) ATG 7.5 mg/kg in three divided doses (2.5 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive higher dose anti-thymocyte globulin intravenously (IV) on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30. |
| 1 | EXPERIMENTAL | Standard (tacrolimus based standard therapy without induction) |
| 2 Standard of Care | ACTIVE_COMPARATOR | Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy |
| 1 Control | ACTIVE_COMPARATOR | Simulect (basiliximab) |
| 2 | EXPERIMENTAL | Thymoglobulin (anti-thymocyte globulin (rabbit)) |
| Dose Level 1 | EXPERIMENTAL | Thymoglobulin 2.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Dose Level 2 | EXPERIMENTAL | Thymoglobulin 3.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Dose Level 3 | EXPERIMENTAL | Thymoglobulin 4.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Name | Type | Description |
|---|---|---|
| Single-dose rabbit Anti-thymocyte Globulin induction | BIOLOGICAL | 6 mg of rATG administered in a single dose on the day of kidney transplantation |
| Divided-dose rabbit Anti-thymocyte Globulin induction | BIOLOGICAL | 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation. |
| Thymoglobulin | BIOLOGICAL | Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7. |
| Total-Body Irradiation | RADIATION | Undergo TBI |
| Allogeneic PBSCT or BMT | PROCEDURE | Undergo allogeneic PBSCT or BMT |
| Tacrolimus | DRUG | Given PO |
| Mycophenolate Mofetil | DRUG | Given PO |
| Corticosteroid | DRUG | For a minimum of 3 months |
| Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] | DRUG | - |
| Simulect (basliximab) | DRUG | 20 mg per day on 2 days |
Inclusion Criteria: * Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation * Male or female subject who has reached legal age in the state where they reside and is at least 18 years of age * Deceased or liv...
Thymoglobulin is an anti-thymocyte globulin (rabbit) preparation developed by Sanofi (ticker SNY). It is a monoclonal antibody studied in transplantation and blood cancer settings, including renal transplantation, liver dysfunction, non-Hodgkin's lymphoma, and relapsed or refractory multiple myeloma. It is investigational and remains in clinical development.
Thymoglobulin has been studied for preventing delayed graft function and acute allograft rejection in renal allograft recipients, for induction therapy in cadaveric donor renal transplantation, for liver transplant rejection, and in non-Hodgkin's lymphoma and relapsed or refractory multiple myeloma. These uses come from completed clinical trials, not from approved labeling.
Thymoglobulin is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development program for this anti-thymocyte globulin (rabbit) product across transplantation and oncology indications.
Thymoglobulin is investigational and has been studied in Phase 1 and Phase 2 clinical trials. The Phase 2 program includes a 240-patient randomized, active-controlled study in renal allograft recipients, a 75-patient liver transplant study, and a 42-patient reduced-intensity conditioning study. No Phase 3 program is listed.
Completed Thymoglobulin trials include NCT00235300, a Phase 2 randomized active-controlled study of 240 renal allograft recipients comparing Thymoglobulin with Simulect; NCT00117689, a Phase 2 liver transplant rejection study of 75 patients; NCT00709592, a Phase 2 reduced-intensity total body irradiation study of 42 patients; and NCT00545519, a Phase 1 multiple myeloma study of 6 patients.
Yes. Thymoglobulin is also known as Thymoglobulin [Anti-thymocyte Globulin (rabbit)] and Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]. These names refer to the same Sanofi product, so searches using the anti-thymocyte globulin (rabbit) wording describe the same investigational agent.