A Study in Adults With Untreated Acute Lymphoblastic Leukemia

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital; Queen Elizabeth II Health Sciences Centre
• Treatments: 6-Mercaptopurine; Asparaginase; Cortisol succinate; Cytarabine; Dexamethasone; Doxorubicin; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Leucovorin; Mercaptopurine; Methotrexate; Prednisone; Vincristine

Criteria

Inclusion Criteria:

• Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL.

• No prior therapy for leukemia with the following exceptions:

• up to one week of steroids;

• emergent leukapheresis;

• emergency treatment for hyperleukocytosis with hydroxyurea;

• cranial RT for CNS leukostasis (one dose only);

• emergent radiation therapy to the mediastinum.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

• Between the ages of 18 to 50 years.

Exclusion Criteria:

• Uncontrolled active infection.

• Pregnancy or nursing mothers.

• Prior history of pancreatitis.

• Prior history of a cerebrovascular accident or hemorrhage.

• Evidence of infection with the human immunodeficiency virus.

• Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.

• The treating physician should consider all relevant medical and other considerations when deciding whether this protocol is appropriate for a particular patient.