Study for Patients with Relapsed Acute Lymphoblastic Leukemia (ALL) Studying the Addition of Inotuzumab Ozogamicin to a Standard 3 and 4 Drug Standard Treatment for ALL

IRB/UVA Tracking #
Principal Investigator
Michael G Douvas
Cory Caldwell
Contact Email
Contact Phone
Official Trial 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)
Study Description

The University of Virginia Cancer Center is conducting a clinical research study for patients who are patients (ages 16 – 60) with acute lymphoblastic leukemia (ALL) who have received initial treatment but the treatment either didn’t work or stopped working. The purpose of this study is to better understand the safety of adding inotuzumab ozogamicin to the standard 3 and 4 drug treatment commonly used in ALL (prednisone, vincristine, and daunorubicin, with or without asparaginase/pegaspargase).
Inotuzumab ozogamicin is approved by the FDA as a single agent in this patient population and it has been very helpful in treating ALL, but it has not been studied and is not approved in combination with some of the other drugs in the combination.
The first group of participants will receive the standard 3- drug combination plus inotuzumab ozogamicin and, if that is found to be safe, then the second group of participants will receive the standard 3-drug combination plus inotuzumab ozogamicin and asparaginase; participants will not get to choose. Participants will receive intravenous inotuzumab ozogamicin on Days 12 and 19 of one, 28-day cycle. All other drugs will be administered according to standard clinical care.
Participants will receive treatment for one 28-day cycle and will be given the choice whether to provide a few blood samples during study treatment for research. Participants will still be followed after they have completed the study treatment, though follow-up after about 30 days after finishing treatment may be by phone or email if preferred. Study-specific tests that are being done beyond standard of care will be provided at no cost to the patient/participant or his/her/their insurance.

Additional information can be found here: ALL 001 -


This study does not offer compensation or reimbursement.