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| Sponsor: | New Mexico Cancer Care Alliance |
|---|---|
| Information provided by (Responsible Party): | New Mexico Cancer Care Alliance |
| ClinicalTrials.gov Identifier: | NCT01011998 |
Purpose
The aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia |
Drug: Gleevec (imatinib), valproic acid |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Imatinib and Valproic Acid in Patients With CML |
| Enrollment: | 0 |
| Study Start Date: | September 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Valproic acid: 250 mg three times per day and then adjusted according to attain a therapeutic level.
Gleevec will be continued at the dose the patient was taking at the time of entry onto the study.
The aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal. Briefly, patients with CML who are taking imatinib and have been found to have a plateau in their level of the bcr-abl transcript will be eligible to participate in the study. Valproate will then be added to the imatinib, and subsequent bcr-abl transcripts will be monitored to see if the addition of valproate produced a further reduction. Patients will be monitored for efficacy and toxicity.
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, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| Principal Investigator: | Ian Rabinowitz, MD | University of New Mexico |
More Information
| Responsible Party: | New Mexico Cancer Care Alliance |
| ClinicalTrials.gov Identifier: | NCT01011998 History of Changes |
| Other Study ID Numbers: | INST 0901 |
| Study First Received: | November 5, 2009 |
| Last Updated: | September 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
CML Chronic Myelogenous leukemia INST 0901 |
imatinib valproic acid Gleevec |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Valproic Acid Imatinib Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Antineoplastic Agents Protein Kinase Inhibitors |