ALL Adult Consortium Trial: Adult ALL Trial

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL>

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Boston Children's Hospital; Boston Children’s Hospital; Massachusetts General Hospital; NCIC Clinical Trials Group
• Treatments: Asparaginase; Cortisol succinate; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methotrexate; Pegaspargase; Vincristine

Criteria

Inclusion Criteria:

• Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)

• Age 18.00-50.99 years

Exclusion Criteria:

• Prior anti-leukemic therapy except 1 week or less of steroids, and/or emergent radiation therapy to the mediastinum, or hydroxyurea or emergent leukopheresis

• Known HIV positive

• Secondary ALL

• Pregnant or breast feeding women

• Patients with an active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely