NCT00271063

Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Callisto Pharmaceuticals · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.

Detailed description

This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal annamycin are planned: 190, 230, 280, and 310 mg/m2/day.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Liposomal Annamycin	3-day IV infusion

Timeline

• Start date: 2005-10-01
• Completion: 2008-04-01
• First posted: 2005-12-30
• Last updated: 2007-12-21

Locations

3 sites across 1 country: United States