Phase I-II Study of Bendamustine in Patients With Acute Leukemia and High-Risk Myelodysplastic Syndrome (MDS)
The Study Drug:
Bendamustine is designed to damage and destroy the DNA of cancer cells.
If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you joined this study. Up to 60 participants will be enrolled in the
Phase I portion of the study, and up to 3 groups of 31 participants will be enrolled in
If you are enrolled in the Phase I portion, the dose of bendamustine you receive will depend
on when you joined this study. The first group of participants will receive the lowest dose
level of bendamustine. Each new group will receive a higher dose of bendamustine than the
group before it, if no intolerable side effects were seen. This will continue until the
highest tolerable dose of bendamustine is found.
If you are enrolled in the Phase II portion, you will receive bendamustine at the highest
dose that was tolerated in the Phase I portion.
Study Drug Administration:
You will receive bendamustine through a needle or catheter in your vein over 2 hours twice
on Days 1-4 of every 4 week study cycle. You will begin a new study cycle when your blood
cell counts have returned to an appropriate level. You may begin a new study cycle earlier
if your disease gets worse or does not improve.
Blood (about 2 tablespoons) will be drawn for routine tests every 3-7 days during Cycle 1,
and then every 1-2 weeks during all other cycles.
A bone marrow aspirate will be performed to check the status of the disease after Cycle 1
and every 3-4 Cycles thereafter, or as needed to document response.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study
early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Bendamustine is not FDA approved or commercially
available in the United States. At this time, bendamustine is only being used in research.
Up to 153 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.
During course 1 (4 week cycle)
Hagop M. Kantarjian, M.D.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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