NCT00144963

Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

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

Timeline

• Start date: 2002-07-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-09-05
• Last updated: 2019-12-12
• Results posted: 2012-01-18

Locations

3 sites across 1 country: United States