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| Sponsor: | University of Kentucky |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00382954 |
Purpose
The purpose of this study is to determine the maximal tolerated dose (MTD) of bortezomib and idarubicin given in combination to newly diagnosed AML patients >60 years or relapsed AML patients.
Another purpose of this study is to determine the dose limiting toxicities associated with bortezomib in combination with idarubicin in newly diagnosed AML patients >60 years or relapsed AML patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia |
Drug: Velcade Drug: Idarubicin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study Using Bortezomib (Velcade, Formerly Known as PS-341) With Weekly Idarubicin for the Treatment of Elderly (>/= 60 Years) and Relapsed Patients With Acute Myelogenous Leukemia |
| Estimated Enrollment: | 55 |
| Study Start Date: | February 2004 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase 1 escalation |
Drug: Velcade
velcade (4 original dosing levels with 3 modified dosing levels) I.V. on days 1, 4, 8, 11, 15, 18, 22, and 25 for 4 weeks concurrent with the Idarubicin
Other Name: Bortezomib
Drug: Idarubicin
I.V., 8, or 10 or 12 mg/m^2 weekly (days 1, 8, 15, and 22) for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Dianna Howard, MD | University of Kentucky |
More Information
| Responsible Party: | Dianna Howard, MD, University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00382954 History of Changes |
| Other Study ID Numbers: | 03-BMT-145 |
| Study First Received: | September 28, 2006 |
| Last Updated: | September 28, 2010 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Acute Myelogenous Leukemia AML Relapse Elderly |
Velcade Idarubicin Bortezomib |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Idarubicin Bortezomib |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |