NCT01439347

A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL

Phase 3 Study of Study to Evaluate Marqibo® in the Combination Chemotherapy in the Treatment of Subjects >or=60 Years Old With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

A phase 3 study in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).

Detailed description

A phase 3, multicenter, randomized study to evaluate the substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for standard Vincristine Sulfate Injection (VSI) in the induction, intensification, and maintenance phases of combination chemotherapy in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).

Conditions

• Acute Lymphoblastic Leukemia (ALL)

Interventions

Type	Name	Description
DRUG	Vincristine Sulfate Liposomes Injection (VSLI)	2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
DRUG	Vincristine Sulfate Injection (VSI)	1.4 mg/m\^2 with a 2 mg dose cap as an IV infusion over 10 minutes.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-09-23
• Last updated: 2021-09-09
• Results posted: 2021-09-09

Locations

15 sites across 1 country: United States