Intravenous Erwinia Chrysanthemi Asparaginase in Patients With Newly Diagnosed Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Aged 60 Years or Older

• Status: Withdrawn
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when used alone and together with chemotherapy and find out what effects, if any, it has on people.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Jazz Pharmaceuticals
• Treatments: Asparaginase

Criteria

Inclusion Criteria:

• Ages 60 years or older

• Previously untreated Philadelphia chromosome negative acute lymphoblastic leukemia

• No prior treatment for ALL, except steroids or hydroxyurea (stopped within 24 hour before start of protocol treatment)

• Serum creatinine ≤ 2 x upper limit of normal (ULN)

• Adequate liver function, including total bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) ≤ 5 x ULN. If organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be ≤ 2 x ULN.

• ECOG performance status ≤3

• Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for a minimum of 90 days after the last dose of treatment on protocol. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential should meet at least one of the following criteria:

• Have undergone hysterectomy or bilateral oophorectomy; or

• Have medically confirmed ovarian failure; or

• Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause

Exclusion Criteria:

• Lymphoblastic crisis of CML

• Mature B cell (Burkitt's) ALL

• Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days, symptomatic CNS leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days. Prophylactic intrathecal medication is not a reason for exclusion.

• Pregnant women or women who are breast-feeding

• Concurrent active malignancy requiring immediate therapy

• Patients with human immunodeficiency virus (HIV)