Phase II Trial of Bendamustine in Adult Patients With Acute Lymphoblastic Leukemia/Lymphoma
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
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.
Hagop Kantarjian, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board