Bendamustine in Acute Lymphoblastic Leukemia/Lymphoma (ALL)
The goal of this clinical research study is to learn if bendamustine can help to control Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied.
Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them to die.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Bendamustine in Adult Patients With Acute Lymphoblastic Leukemia/Lymphoma|
- Overall Response Rate (ORR) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]Primary endpoint for evaluating efficacy objective response rate (ORR = complete remission (CR), complete response with no recovery of platelet count > 100 k/mm3 (CRp), complete response criteria with no recovery of absolute neutrophil count greater than 1000/mm3 and/or platelet count > 100 k/mm3 (CRi), partial response (PR). Disease-free survival (DFS) time from date of treatment start until date of first objective documentation of disease-relapse. Overall survival (OS) time from date of treatment start until date of death due to any cause or last follow up.
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Patients receive Bendamustine at dose of 75 mg/m2 by vein over 30 minutes twice daily for four days (Days 1-4). Bendamustine dose based on actual body weight.
Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses.
75 mg/m2 by vein twice daily for four days (Days 1-4). Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses.
Study Drug Administration:
Patient will receive bendamustine by vein over 30 minutes twice a day on Days 1-4 of every study cycle. The length of each study cycle will depend on how the disease responds to the study drug. Each cycle will last 3 to 10 weeks.
Before each cycle, patient will have a physical exam, including measurement of vital signs.
One (1) time each week, blood (about 2 tablespoons) will be drawn for routine tests. These blood draws will no longer be drawn every week if at any point the disease appears to be getting better. After that, this blood will only be drawn every 2-4 weeks while patient is receiving the study drug. These blood draws can be performed by a doctor near the patient and the results will be reported to the study doctor.
On Day 21 of Cycle 1, then every 4 weeks, patient will have a bone marrow aspirate and/or biopsy to check the status of the disease. If patient's doctor thinks it is needed, bone marrow aspirates and/or biopsies may be collected more or less often, depending on the status of the disease.
Length of Treatment:
Patient may receive up to 12 cycles of the study drug. Patient will be taken off study early if the disease gets worse, if intolerable side effects occur, or if the study doctor thinks it is in patient's best interest. Patient's participation in the study will be over after they complete the follow-up visits.
Patient will be asked to return to the clinic every 3 to 6 months for up to 5 years after they stop receiving the study drug. Patient will be asked about any side effects or symptoms they may be having. If patient is are unable to return to MD Anderson, the follow-up visits may be conducted over the phone. Each call should last about 5 minutes.
Blood (about 2 tablespoons) will also be drawn for routine tests every 4-8 weeks during this follow-up period.
This is an investigational study. Bendamustine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.