Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2021-05-27
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well low-intensity chemotherapy and blinatumomab work in treating patients with Philadelphia chromosome negative acute lymphoblastic leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine and vincristine sulfate, 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 blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving low-intensity chemotherapy and blinatumomab may work better at treating acute lymphoblastic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Amgen; National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Bispecific; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; BB 1101; Blinatumomab; Calcium; Calcium, Dietary; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone acetate; Folic Acid; Immunoglobulins; Lenograstim; Leucovorin; Levoleucovorin; Mercaptopurine; Mesna; Methotrexate; Muromonab-CD3; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Patients with first or second relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)

• Performance status =< 3 (Eastern Cooperative Oncology Group [ECOG] scale)

• Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)

• Alanine aminotransferase (ALT) =< 3 x ULN, unless due to the underlying leukemia approved by the PI

• Aspartate aminotransferase (AST) =< 3 x ULN unless due to the underlying leukemia approved by the PI

• Signed informed consent

• 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:

• Patients with Philadelphia chromosome (Ph)-positive ALL or Burkitt leukemia

• Active, uncontrolled central nervous system (CNS) leukemia involvement

• Active serious infection not controlled by oral or intravenous antibiotics

• Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year

• Known hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)

• Active grade III-V cardiac failure as defined by the New York Heart Association criteria

• Patients with a cardiac ejection fraction (as measured by either multi-gated acquisition [MUGA] or echocardiogram) < 40%

• Prior history of treatment with blinatumomab

• Treatment with any investigational antileukemic agents or chemotherapy agents in the last two weeks, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator

• Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception; women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control