PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Optimal Dose of VIC-1911 When Given in Combination With Standard Immunosuppressive Therapy in Adult Patients Undergoing Myeloablative Stem Cell Transplantation. |
75 | — |
| PRIMARY Progression-free Survival |
100; 100; 100 | — |
| PRIMARY Relapsed Assessment (Phase I) |
— | — |
| SECONDARY Overall Survival (OS) |
100 | — |
| SECONDARY To Determine the Cumulative Incidences of Acute GVHD |
6 | — |
| SECONDARY To Determine the Cumulative Incidences of Chronic GVHD |
0; 0; 33 | — |
| SECONDARY Progression-free Survival Comparing Graft-Versus-Host Disease-Free (GRFS) to the Standard PTCY Plus Tacrolimus/Mycophenolate Mofetil Regimen From MT2015-29 |
100; 100; 67 | — |
| SECONDARY Progression Free Survival |
100 | — |
| SECONDARY Frequency of CMV Reactivation and Disease |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of
- acute leukemia in complete remission, or
- myelodysplasia with 4 or unable to receive myeloablative TBI
- Use of planned post-transplant maintenance therapy to begin prior to day +75. Patients may receive standard of care maintenance therapies starting at day
+75 or later
- Patients with a history of hypersensitivity to any of the investigational products
- Pregnant or breastfeeding as agents used in this study are Pregnancy Category
o C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations, and Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 28 days of study registration.
- Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 60 days after the last treatment of VIC-1911 or sirolimus
Data sourced from ClinicalTrials.gov (NCT05120570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.