Treatment of Older Adults With Acute Lymphoblastic Leukemia
Status: Recruiting
Phase: Phase 2
Diagnosis: Leukemia/MDS
NCT ID: NCT00973752
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 08-356
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.
Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital
Overall PI:
Karen Ballen, MD,
Massachusetts General Hospital
Site-responsible Investigators:
David Avigan, MD,
Beth Israel Deaconess Medical Center
Daniel DeAngelo, MD,
Dana-Farber Cancer Institute
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility 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 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