Treatment of Acute Lymphoblastic Leukemia in Children

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued because of intolerable side-effects had survival outcomes that were inferior to those who received all or nearly all of their intended doses. Two bacterial sources of asparaginase exist: Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived enzyme has been used as front-line therapy and the Erwinia-derived preparation has been reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase (PEG-asparaginase) has a longer half-life and is potentially less immunogenic than native E coli L-asparaginase, and has been used as the initial asparaginase preparation in some pediatric acute lymphoblastic leukemia treatment regimens.

PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations:

intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase (IM-EC) have been well characterized, their relative efficacy and toxicity have not been studied extensively.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Asparaginase; Cortisol succinate; Cyclophosphamide; Cytarabine; Dexamethasone; Dexrazoxane; Doxorubicin; Etoposide; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Pegaspargase; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Razoxane; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute lymphoblastic leukemia (ALL)

• No known mature B-cell ALL, defined by the presence of any of the following:

• Surface immunoglobulin

• L3 morphology

• t(8;14)(q24;q32)

• t(8;22)

• t(2;8)

• T-cell surface markers and t(8;14)(q24;q11) allowed

• No secondary ALL

PATIENT CHARACTERISTICS:

• No known HIV positivity

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior therapy except steroids of ≤ 1 week in duration and/or emergent radiation therapy to the mediastinum

• Patients treated with steroids within the past 7 days will not receive steroid prophase during study treatment