Status:
COMPLETED
Treatment of Older Adults With Acute Lymphoblastic Leukemia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
51-75 years
Phase:
PHASE2
Brief 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) whi...
Detailed Description
* This research study has stages of treatment as follows: 1) Induction 2) Consolidation 1 3) Stem cell of Bone Marrow Transplant (if the participant is eligible). If the participant does not have a tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00973752
Start Date
August 1 2009
End Date
April 1 2016
Last Update
March 30 2017
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115