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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Patients with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL; minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed

• Zubrod performance status 0-3

• Bilirubin =< 1.95 mg/dL

• Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =< 3 x upper limit of normal (ULN) unless considered due to tumor

• Creatinine =< 2 mg/dL

• Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is =< 2.6 mg/dL and creatinine =< 3 mg/dL

• Provision of written informed consent

• Patients in first remission are eligible

• Patients with refractory-relapsed ALL of any age are eligible

Exclusion Criteria:

• Burkitt's leukemia or lymphoma, T-cell ALL or lymphoblastic lymphoma

• Patient with active heart disease (New York Heart Association [NYHA] class >= 3 as assessed by history and physical examination)

• Patients with a cardiac ejection fraction (as measured by either multigated acquisition scan [MUGA] or echocardiogram) < 40% are excluded

• Patients with active hepatitis are excluded

• Pregnant or breast-feeding women are excluded