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| Sponsors and Collaborators: |
University of California, San Diego Celgene Corporation |
|---|---|
| Information provided by: | University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00766116 |
Purpose
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: 5-Azacitidine, Mylotarg |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I/II Trial of the Combination 5-Azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML |
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Treatment: Experimental |
Drug: 5-Azacitidine, Mylotarg
A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit M = Mylotarg given 2 times over 2 weeks
|
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5azacitidine followed by Mylotarg administered two times over two weeks
In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.
A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Edward D Ball, MD | 858-822-6600 | tball@ucsd.edu |
| Contact: Sue Corringham, RN | 858-822-6387 | scorringham@ucsd.edu |
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Bruno Medeiros, MD 650-725-3973 brunom@stanford.edu | |
| Contact: Richa Rajwanshi, CRC 650-736-4301 richar@stanford.edu | |
| Principal Investigator: Bruno Medeiros, MD | |
| United States, Georgia | |
| Northside Hospital/BMTGA | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Asad Bashey, MD 404-255-1930 abashey@bmtga.com | |
| Contact: Linda Vrooman, RN 404-845-5926 linda.vrooman@northside.com | |
| Principal Investigator: Asad Bashey, MD | |
More Information
| Responsible Party: | UCSD ( Dr. Edward Ball ) |
| Study ID Numbers: | 050938 |
| Study First Received: | October 2, 2008 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00766116 |
| Health Authority: | United States: Institutional Review Board |
|
AML |
|
Leukemia Azacitidine Acute myelogenous leukemia Leukemia, Myeloid |
Gemtuzumab Leukemia, Myeloid, Acute Acute myelocytic leukemia |
|
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |
