drugset / Trial / NCT03441061
Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
Phase 2
Active not recruiting
40 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase II trial studies how well inotuzumab ozogamicin works in treating patients with B-cell acute lymphocytic leukemia with positive minimal residual disease. Inotuzumab ozogamicin is a monoclonal antibody called inotuzumab linked to a toxic agent called ozogamicin. Inotuzumab ozogamicin attaches to B cell-specific CD22 cancer cells in a targeted way and kills them.
Timeline
- Start
- 2018-02-15
- Primary completion
- 2027-02-28
- Completion
- 2027-02-28
Publications
- Zhao Y, Short NJ, Kantarjian HM, Chang TC, Ghate PS, Qu C, Macaron W, Jain N, Thakral B, Phillips AH, Khoury J, Garcia-Manero G, Zhang W, Fan Y, Yang H, Garris RS, Nasr LF, Kriwacki RW, Roberts KG, Konopleva M, Jabbour EJ, Mullighan CG. Genomic determinants of response and resistance to inotuzumab ozogamicin in B-cell ALL. Blood. 2024 Jul 4;144(1):61-73. doi: 10.1182/blood.2024023930.
- Jabbour E, Haddad FG, Short NJ, Senapati J, Jain N, Sasaki K, Jorgensen J, Wang SA, Alvarado Y, Wang X, DiNardo C, Masarova L, Kadia T, Garris RS, Ravandi F, Kantarjian H. Phase 2 study of inotuzumab ozogamicin for measurable residual disease in acute lymphoblastic leukemia in remission. Blood. 2024 Feb 1;143(5):417-421. doi: 10.1182/blood.2023022330.
- Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.3 mg/m2 | Intravenous |