Bendamustine in Acute Leukemia and MDS
The goal of the Phase I part of this clinical research study is to find the highest safe dose of bendamustine that can be given to patients with acute myelogenous leukemia (AML), Acute lymphoblastic leukemia (ALL), Chronic myelogenous (or myeloid) leukemia (CML) in blastic phase, Chronic Myelomonocytic Leukemia (CMML), and myelodysplastic syndromes (MDS).
The goal of the Phase II part of this clinical research study is to learn if bendamustine can help to control AML, ALL and MDS. The safety of this drug will continue to be studied.
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Study of Bendamustine in Patients With Acute Leukemia and High-Risk Myelodysplastic Syndrome (MDS)|
- Maximum Tolerated Dose (MTD) [ Time Frame: During course 1 (4 week cycle) ] [ Designated as safety issue: Yes ]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.
- Number of Participants With a Response [ Time Frame: 1 - 24 week cycles (up to 8 weeks) ] [ Designated as safety issue: No ]A complete response (CR) is defined as normalization of the bone marrow and peripheral blood counts with </= 5% marrow blasts in a normo-or hypercellular marrow, with a granulocyte count of >/= 10^9/L and a platelet count of >/=100 X 10^9/L. A partial response (PR) was defined as for CR, but with only >/=50% reduction of marrow blasts and to a range of 6%-25%. A marrow complete response was defined as a reduction of marrow blasts to </=5% but without recovery of peripheral counts.
|Study Start Date:||November 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
Starting dose of 50 mg/m^2 through a needle or catheter in vein over 2 hours twice on Days 1-4 of every 4 week study cycle. A new study cycle may begin when blood cell counts have returned to an appropriate level or a new study cycle may begun earlier if disease gets worse or does not improve.
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 Phase II.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790855
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hagop M. Kantarjian, M.D.||M.D. Anderson Cancer Center|