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DepoCyt
Clinical Pharmacology
DepoCyt
The second study was a randomized, multi-center, multi-arm study involving a total of 124 treated patients with either solid tumors or lymphomas. In this study, 24 patients with lymphoma were randomized and treated with DepoCyt or cytarabine, Patients received 6 two-week induction cycles of DepoCyt 50 mg every 2 weeks or cytarabine 50 mg twice weekly. Patients then received four maintenance cycles of DepoCyt 50 mg every 4 weeks, or cytarabine 50 mg weekly for 4 weeks. In both studies, patients received concurrent treatment with dexamethasone to minimize symptoms associated with chemical arachnoiditis (see WARNINGS and DOSAGE AND ADMINISTRATION). In this study, cytological response was assessed in a blinded fashion utilizing a similar definition as in the first study. The results in patients with lymphomatous meningitis are shown in Table 1.
Table 1: Complete Cytological Responses in Patients with Lymphomatous Meningitis
| DepoCyt® | Cytarabine | |
| Study 1 | 7/17 (41%) | 1/16 (6%) |
| 95% CI | (18%, 67%) | (0%, 30%) |
| Study 2 | 4/12 (33%) | 2/12 (17%) |
| 95% CI | (10%, 65%) | (2%, 48%) |
Generic Name: Cytarabine Liposome Injection
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