Overview

Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia

Status:
Recruiting

Trial end date:
2025-12-25

Target enrollment:

Participant gender:

Summary

This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborators:

National Cancer Institute (NCI)
Pfizer

Treatments:

6-Mercaptopurine
Antibodies
Antibodies, Bispecific
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
BB 1101
Blinatumomab
Cortisone
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Folic Acid
Immunoglobulins
Inotuzumab Ozogamicin
Leucovorin
Levoleucovorin
Mercaptopurine
Mesna
Methotrexate
Muromonab-CD3
Prednisone
Rituximab
Vincristine