Conditions: Acute Lymphoblastic Leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Detailed description:
OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
* Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

Arms:
arm 1: Vincristine Sulfate Liposomes Injection (VSLI)

Interventions: intervention 1: Vincristine Sulfate Liposomes Injection intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days). intervention 2: Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).

Protocol document: