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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Cephalon |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00790855 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia |
Drug: Bendamustine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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) |
| Estimated Enrollment: | 153 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bendamustine |
Drug: Bendamustine
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.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Hagop Kantarjian M.D./Professor, The University of Texas M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00790855 History of Changes |
| Other Study ID Numbers: | 2007-0634 |
| Study First Received: | November 13, 2008 |
| Last Updated: | May 11, 2011 |
| 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 |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Bendamustine Nitrogen Mustard Compounds Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |