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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Cephalon |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00790855 |
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 AML, ALL, CML in blastic phase, CMML, and 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.
Optional Procedures: You will be asked to allow additional blood to be drawn to measure the effect of bendamustine on DNA (the genetic material of cells), for pharmacokinetic (PK) testing, and for pharmacodynamic (PD) testing. PK testing measures the amount of study drug in the body at different time points. PD testing is used to look at how the level of study drug in your body may affect the disease.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia |
Drug: Bendamustine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I-II Study of Bendamustine in Patients With Acute Leukemia and High-Risk Myelodysplastic Syndrome (MDS) |
Estimated Enrollment: | 153 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Bendamustine: Experimental
Arm 1
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Drug: Bendamustine
Bendamustine 50mg/m2 IV over 1-2 hours twice daily (about every 12 hours ± 3 hours) x 4 days every 4 weeks. Therapy can start earlier (e.g. every 3 weeks) if evidence of persistent or progressive disease.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hagop M. Kantarjian, M.D. | 713/792-7026 | hkantarj@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Hagop M Kantarjian, MD 713-792-7026 hkantarj@mdanderson.org | |
Principal Investigator: Hagop M. Kantarjian, M.D. |
Principal Investigator: | Hagop M. Kantarjian, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Hagop Kantarjian M.D./Professor ) |
Study ID Numbers: | 2007-0634 |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00790855 |
Health Authority: | United States: Food and Drug Administration |
Bendamustine Acute Leukemia Leukemia Acute myeloid leukemia Myelodysplastic Syndrome Acute lymphoblastic leukemia |
Chronic myeloid leukemia MDS ALL AML CML |
Myelodysplastic syndromes Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Chronic myelogenous leukemia Precancerous Conditions Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Myeloproliferative Disorders |
Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia Lymphatic Diseases Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders Acute myelocytic leukemia Lymphoma Bendamustine |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Syndrome Pharmacologic Actions |