Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia

• Status: Terminated
• Trial end date: 2020-04-02
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.

• Phase: 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, Monoclonal; Antineoplastic Agents, Immunological; BB 1101; Calcium; Calcium, Dietary; Cortisone; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone acetate; Doxorubicin; Folic Acid; Immunoglobulins; Inotuzumab Ozogamicin; Lenograstim; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Mercaptopurine; Mesna; Methotrexate; Ofatumumab; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Patients with newly diagnosed, previously untreated B-lineage ALL, or having achieved complete remission (CR) with one course of induction chemotherapy

• Patients with extramedullary disease only are eligible

• Failure to one induction course of chemotherapy (these patients will be analyzed separately)

• Performance status of 0-3

• Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)

• Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)

• Adequate cardiac function as assessed by history and physical examination

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

• Women of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP must agree to use contraception during the study, if sexually active

Exclusion Criteria:

• Pregnant or nursing women

• Known to be human immunodeficiency virus (HIV)-positive

• Philadelphia chromosome (Ph)-positive ALL

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

• Unable or unwilling to sign the consent form

• Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement or stable chronic liver disease per investigator assessment)

• Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C