drugset / Trial / NCT01994382
Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.
Timeline
- Start
- 2013-08-30
- Primary completion
- 2020-12-15
- Completion
- 2020-12-15
Publications
- Results Paul A. Hamlin, Manish R. Patel, Don Stevens, Brian T. Hess, Javier Munoz, Tatyana A. Feldman, Sonali M. Smith, Greg P. Coffey, Muhtarjan Osman, Jaymes S Holland, Cristina B Guzman, Stephen D. Smith; Phase 2a Study of the Dual SYK/JAK Inhibitor Cerdulatinib (ALXN2075) As Monotherapy or in Combination with Rituximab in Patients with Relapsed/Refractory Follicular Lymphoma. Blood 2021; 138 (Supplement 1): 2423. doi: https://doi.org/10.1182/blood-2021-148313
- Coffey GP, Feng J, Betz A, Pandey A, Birrell M, Leeds JM, Der K, Kadri S, Lu P, Segal J, Wang YL, Michelson G, Curnutte JT, Conley PB. Cerdulatinib Pharmacodynamics and Relationships to Tumor Response Following Oral Dosing in Patients with Relapsed/Refractory B-cell Malignancies. Clin Cancer Res. 2019 Feb 15;25(4):1174-1184. doi: 10.1158/1078-0432.CCR-18-1047. Epub 2018 Oct 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cerdulatinib | Small molecule | 15 mg | Oral |
| Subject | Cerdulatinib | Small molecule | 20 mg | Oral |
| Subject | Cerdulatinib | Small molecule | 30 mg | Oral |
| Subject | Cerdulatinib | Small molecule | 35 mg | Oral |
| Subject | Cerdulatinib | Small molecule | 45 mg | Oral |
| Subject | Cerdulatinib | Small molecule | 100 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |