| Company Name | Pfizer |
|---|---|
| Protocol Number | B1931030 |
| Title of Study | A Phase 4, Open-Label, Randomized study of two Inotuzumab ozogamicin dose levels in adult patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia eligible for Hematopoietic Stem cell Transplantation and who have Risk factor(s) for veno-occlusive Disease. |
| Primary Objective | To evaluate the rates of VOD and hematologic remission (CR/CRi) for 2 inotuzumab ozogamicin dose levels in adult patients with relapsed or refractory B-cell ALL who are eligible for HSCT and who are at higher risk for developing VOD post-HSCT. |
| Number of Sites | 3 |
| Period of Study | From：2019/07/01 to：2025/08/18 |
| Number of Patients | 人 |
| IRB Approval Date | TPVGH: 2019/06/21 CCH: 2019/07/16 HTUH: 2019/08/12 |
| Publication Plan / Date | 2025/01/02 |
