Treatment of Older Adults With Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of a multi-drug regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine, and methotrexate) which is considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy treatment regimens for children with ALL and has been shown to decrease the number of leukemia cells. Participants with leukemia that has an abnormal chromosome, called the Philadelphia chromosome, will also be given imatinib.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute; Enzon Pharmaceuticals, Inc.; Genzyme, a Sanofi Company
• Treatments: 6-Mercaptopurine; Asparaginase; Clofarabine; Cytarabine; Doxorubicin; Mercaptopurine; Methotrexate; Pegaspargase; Prednisone; 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).

• Patients with mature B-cell ALL will be removed from the protocol as soon as the diagnosis is made and should be treated on a B-cell leukemia protocol.

• Patients with lymphoblastic lymphoma are also eligible

• No prior anti-leukemic therapy except <1 week of steroids, and/or emergent radiation therapy to the mediastinum, or hydroxyurea or emergent leukopheresis. Longer steroid use for diseases other than leukemia is permitted.

• Age 51-75 years

• Ejection fraction > 45%

• Creatinine < 2.0 mg/dl

• Total bilirubin < 3.0 mg/dl

• ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, 2

• Non-pregnant and non lactating

Exclusion Criteria:

• Known HIV positive

• Comorbid medical condition, in the investigator's opinion, would make participation in this trial and adherence to the protocol guidelines difficult

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