Conditions: Acute Lymphoblastic Leukemia (ALL)
Keywords: Marqibo HALLMARQ leukemia front-line ALL acute lymphoblastic leukemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

Brief 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).

Arms:
arm 1: VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes. arm 2: Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.

Interventions: intervention 1: Vincristine Sulfate Liposomes Injection (VSLI) intervention 2: Vincristine Sulfate Injection (VSI)
Intervention descriptions: intervention 1: 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes. intervention 2: 1.4 mg/m\^2 with a 2 mg dose cap as an IV infusion over 10 minutes.

Protocol document: