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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00413166 |
The goal of this clinical research study is to learn if starting arsenic trioxide (ATO) therapy on Day 1 rather than Day 10 is more effective in treating patients with newly-diagnosed APL. Researchers also want to learn if theophylline can help to control APL.
Condition | Intervention |
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Acute Promyelocytic Leukemia |
Drug: All-Trans Retinoic Acid Drug: Arsenic Trioxide Drug: Gemtuzumab Ozogamicin Drug: Theophylline |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment of APL With All-Trans Retinoic Acid, and Arsenic +/- Gemtuzumab and Theophylline |
Estimated Enrollment: | 50 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
All-Trans Retinoic Acid + Arsenic Trioxide
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Drug: All-Trans Retinoic Acid
All-Trans Retinoic Acid 45 mg/m2 daily
Drug: Arsenic Trioxide
Arsenic Trioxide 0.15mg/kg daily
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2: Experimental
All-Trans Retinoic Acid + Arsenic Trioxide + Gemtuzumab Ozogamicin + Theophylline
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Drug: All-Trans Retinoic Acid
All-Trans Retinoic Acid 45 mg/m2 daily
Drug: Arsenic Trioxide
Arsenic Trioxide 0.15mg/kg daily
Drug: Gemtuzumab Ozogamicin
Gemtuzumab Ozogamicin 9 mg/m2 day 1
Drug: Theophylline
Theophylline 100mg days 1-3 200mg days 4-6 300mg days thereafter
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Farhad Ravandi-Kashani,, MD | 713-745-0394 | fravandi@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Farhad Ravandi-Kashani, MD 713-745-0394 fravandi@mdanderson.org |
Principal Investigator: | Farhad Ravandi-Kashani, MD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Farhad Ravandi-Kashani, M.D./Associate Professor ) |
Study ID Numbers: | 2006-0706 |
Study First Received: | December 15, 2006 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00413166 |
Health Authority: | United States: Institutional Review Board |
Acute Promyelocytic Leukemia APL ATRA All-Trans Retinoic Acid |
Arsenic Trioxide Theophylline Gemtuzumab |
Antibodies, Monoclonal Leukemia Antibodies Acute promyelocytic leukemia Leukemia, Promyelocytic, Acute Tretinoin |
Arsenic trioxide Leukemia, Myeloid Gemtuzumab Leukemia, Myeloid, Acute Immunoglobulins Theophylline |
Respiratory System Agents Vasodilator Agents Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents |
Pharmacologic Actions Keratolytic Agents Neoplasms Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |