NCT03962465 - Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 22, 2022

Primary Completion Date

July 15, 2023

Study Completion Date

July 31, 2026

Conditions

B-cell Acute Lymphoblastic Leukemia

Interventions

DRUG

Inotuzumab ozogamicin

By IV, given on days 12 and 19 Inotuzumab ozogamicin is approved as a single-agent in this population (patients with B-ALL) but adding it to these drug combinations has not been tested in humans

DRUG

Prednisone Pill

Taken daily days 1-28 by mouth

DRUG

Daunorubicin

By IV, given on days 1, 8, 15, and 22

DRUG

Vincristine

By IV, given on days 1, 8, 15, and 22

DRUG

Cytarabine

Intrathecal, administered on day 1 only

DRUG

Methotrexate

Intrathecal, administered on days 8 and 29

DRUG

Pegaspargase

By IV, given on day 4

Trial Locations (4)

22908

University of Virginia, Charlottesville

23298

VCU Massey Cancer Center, Richmond

37232

Vanderbilt-Ingram Cancer Center, Nashville

53792

University of Wisconsin, Madison