drugset / Trial / NCT01134575
CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
Phase 2
Completed
90 enrolled
M.D. Anderson Cancer Center
Wyeth is now a wholly owned subsidiary of Pfizer · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to learn if CMC-544 given alone, and possibly given in combination with rituximab, can help to control the disease in patients with ALL. The safety of the study drug(s) will also be studied.
Timeline
- Start
- 2010-06-04
- Primary completion
- 2018-04-18
- Completion
- 2018-04-18
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.
- Kantarjian H, Thomas D, Jorgensen J, Jabbour E, Kebriaei P, Rytting M, York S, Ravandi F, Kwari M, Faderl S, Rios MB, Cortes J, Fayad L, Tarnai R, Wang SA, Champlin R, Advani A, O'Brien S. Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol. 2012 Apr;13(4):403-11. doi: 10.1016/S1470-2045(11)70386-2. Epub 2012 Feb 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.5 mg/m2 | Intravenous |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 1.3 mg/m2 | Intravenous |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 1.8 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |