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Also known as Post-transplant Cyclophosphamide (PTCy)
Post-transplant Cyclophosphamide · 1 trial · 1 indication
OS is defined as the time from the first dose of study treatment to the time of death due to any cause. Patients who are still alive will be censored at the date last known alive of the data cut-off date (if applicable), whichever is earlier.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Fludarabine and Intermediate-dose Total Body Irradiation (800 cGy) Followed by Post-transplant Cyclophosphamide |
| Name | Type | Description |
|---|---|---|
| Fludarabine | DRUG | Patients will receive fludarabine administered at the dose of 30 mg/m2 intravenously daily on Days -6 to -2 |
| Intermediate-dose Total Body Irradiation (TBI) | RADIATION | Patients will receive intermediate-dose total body irradiation (TBI) administered at the dose of 800 cGy in 4 total fractions, 2 fractions per day on Days -2 to -1 |
| Post-transplant Cyclophosphamide (PTCy) | DRUG | Patients will receive post-transplant cyclophosphamide (PTCy) administered at the dose of 40 mg/kg intravenously on Days +3 to +4. |
| Tacrolimus | DRUG | Patients will receive tacrolimus administered at a dose adjusted to maintain trough levels between 5-15 ng/mL orally starting on Days +5. |
| Mycophenolate mofetil (MMF) | DRUG | Patients will receive mycophenolate mofetil (MMF) administered at the standard dose of 15 mg/kg orally three times daily starting on Day +5 to Day +35 or per institutional guidelines. |
Inclusion Criteria: * Patients ages 18-65 years. * Patients with a diagnosis of one of the following hematologic malignancies: * Acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow; * Myelodysplastic syndrome with less than 5% bla...
Post-transplant Cyclophosphamide (PTCy) is used in allogeneic stem cell transplant recipients. It is being studied as part of a conditioning regimen for patients with hematologic malignancies undergoing allogeneic stem cell transplantation. The drug is currently in Phase 2 clinical development for this indication.
Post-transplant Cyclophosphamide is a small molecule that targets rapidly dividing cells, including activated T cells that cause graft-versus-host disease after allogeneic stem cell transplantation. By selectively depleting these cells, it helps prevent transplant rejection and reduce the risk of graft-versus-host disease.
Post-transplant Cyclophosphamide is being developed by Meridian Bioscience Inc, which trades under the ticker VIVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in allogeneic stem cell transplant recipients.
Post-transplant Cyclophosphamide is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is currently recruiting participants to further evaluate its use in allogeneic stem cell transplantation.
Post-transplant Cyclophosphamide is being studied in a Phase 2 clinical trial with the identifier NCT07214688. The trial, titled 'Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies,' is recruiting 209 participants in the United States. The study is uncontrolled and not blinded.
Yes, Post-transplant Cyclophosphamide is also known as PTCy. The abbreviation PTCy is commonly used in clinical research and medical literature to refer to this drug, particularly in the context of its use in allogeneic stem cell transplantation.