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Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL
Sponsor: University of Virginia
Summary
In the proposed study, escalating doses of inotuzumab ozogamicin will be added to a standard pediatric inspired re-induction regimen and administered to patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Two re-induction regimens will be tested (one without pegaspargase and one including pegaspargase) and participants will be followed for disease status, allogeneic hematopoietic cell transplant (allo HCT), veno-occlusive disease following allo HCT, and overall survival.
Official title: Phase I Study of Inotuzumab Ozogamicin With 3 and 4 Drug Augmented Berlin-Frankfurt-Münster (BFM) Re-Induction for Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)
Key Details
Gender
All
Age Range
16 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2022-07-22
Completion Date
2026-07
Last Updated
2023-08-22
Healthy Volunteers
No
Conditions
Interventions
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
Prednisone Pill
Taken daily days 1-28 by mouth
Daunorubicin
By IV, given on days 1, 8, 15, and 22
Vincristine
By IV, given on days 1, 8, 15, and 22
Cytarabine
Intrathecal, administered on day 1 only
Methotrexate
Intrathecal, administered on days 8 and 29
Pegaspargase
By IV, given on day 4
Locations (4)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States