drugset / Trial / NCT00586924
A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia
Non-randomizedSequentialOpen-labelTreatment
Summary
A dose-escalation study to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), defined as the highest dose that can safely be given to a participant and establish the safest dose based on the highest tolerated dose for clinical testing.
Timeline
- Start
- 2007-05-10
- Primary completion
- 2015-05-06
- Completion
- 2015-05-06
Publications
- Results Kreitman RJ, Tallman MS, Robak T, Coutre S, Wilson WH, Stetler-Stevenson M, Fitzgerald DJ, Lechleider R, Pastan I. Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia. J Clin Oncol. 2012 May 20;30(15):1822-8. doi: 10.1200/JCO.2011.38.1756. Epub 2012 Feb 21.
- Kreitman RJ, Tallman MS, Robak T, Coutre S, Wilson WH, Stetler-Stevenson M, FitzGerald DJ, Santiago L, Gao G, Lanasa MC, Pastan I. Minimal residual hairy cell leukemia eradication with moxetumomab pasudotox: phase 1 results and long-term follow-up. Blood. 2018 May 24;131(21):2331-2334. doi: 10.1182/blood-2017-09-803072. Epub 2018 Feb 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Moxetumomab Pasudotox | Protein / enzyme biologic | 5 ug/kg | Intravenous |
| Subject | Moxetumomab Pasudotox | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | Moxetumomab Pasudotox | Protein / enzyme biologic | 20 ug/kg | Intravenous |
| Subject | Moxetumomab Pasudotox | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | Moxetumomab Pasudotox | Protein / enzyme biologic | 40 ug/kg | Intravenous |
| Subject | Moxetumomab Pasudotox | Protein / enzyme biologic | 50 ug/kg | Intravenous |