Overview

Study of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

Status:
Recruiting

Trial end date:
2023-02-01

Target enrollment:
40

Participant gender:
All

Summary

The goal of this clinical research study is to learn how well low-dose inotuzumab ozogamicin may help to control acute lymphocytic leukemia (ALL). The safety of the study drug will also be studied. This is an investigational study. Inotuzumab ozogamicin is FDA approved and commercially available for the treatment of ALL. The study doctor can explain how the study drug is designed to work. Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Pfizer

Criteria

Inclusion Criteria:

1. Patients at least 18 years of age.

2. Patients with B-lineage ALL in hematologic complete remission (CR) with molecular
failure (ie, had never achieved an MRD-negativity status before inotuzumab ozogamicin)
or had a molecular relapse (ie, became MRD positive after having been MRD negative)
starting at any time point after 3 months of frontline therapy. Molecular disease or
minimal residual disease is defined by a value of at least of 10^-4 by multicolor flow
cytometry.

3. Patients with B-lineage ALL in CR2 and beyond with molecular failure at any time point
after 2 months of salvage therapy are allowed

4. Performance status of 0, 1, or 2

5. Adequate organ function with creatinine clearance >/=15 ml/min and bilirubin <1.5 X
ULN and AST or ALT <2X ULN.

6. No active or co-existing malignancy with life expectancy less than 12 months.

Exclusion Criteria:

1. Pregnant or nursing women

2. Known to be HIV+

3. Ph+ ALL

4. Active and uncontrolled disease/infection as judged by the treating physician

5. Unable or unwilling to sign the consent form

6. Prior allogeneic stem cell transplantation

7. Active CNS or extramedullary disease

8. Monoclonal antibodies therapy within 2 weeks before study entry

9. Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or
low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate,
steroids) or any investigational drug within 2 weeks before study entry