Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

February 1, 2022

Study Completion Date

February 1, 2022

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Blinatumomab

Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT).

PROCEDURE

Hematopoietic Cell Transplantation

Hematopoietic progenitor cell infusion

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER