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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00727766 |
This is a phase I study designed to test the safety of oral clofarabine when given as consolidation therapy to older patients with AML in remission.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myeloid, Acute |
Drug: Clofarabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase I Study of Oral Clofarabine Consolidation in Adults Aged 60 and Older With Acute Myeloid Leukemia |
Estimated Enrollment: | 30 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Clofarabine
Clofarabine 1-5 mg po on days 1 to 14-21 of a 28 day cycle for up to 5 cycle.
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The prognosis of acute myeloid leukemia (AML) in patients 60 and older is dismal with traditional therapy. Several factors contribute to the poor prognosis of older individuals, including the increased incidence of the multidrug resistance efflux pump, comorbidities and unfavorable cytogenetics. The recently reported AML-13 and ALFA trials suggest that less intense consolidation in this population is at least equivalent to more intense, induction style efforts.
Clofarabine is a next generation nucleoside analogue that was designed to optimize the favorable attributes of fludarabine and cladribine, while minimizing toxicity. The intravenous formulation has shown considerable activity in older patients with AML who have been considered either unfit for or unlikely to benefit from conventional therapy. Additionally, clofarabine has an oral formulation that patients may find more acceptable for consolidation therapy rather than multiple courses of intravenous medications, administered over several days.
This study is designed as a traditional 3x3 phase I trial with the intention of defining the maximum tolerated dose of oral clofarabine consolidation for older patients with AML in remission.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Camille Abboud, M.D. | 314-747-8304 | cabboud@dom.wustl.edu |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Camille Abboud, M.D. 314-454-8304 cabboud@dom.wustl.edu | |
Sub-Investigator: Mike Martin, M.D. | |
Sub-Investigator: John F DiPersio, M.D., Ph.D. | |
Sub-Investigator: Geoffrey Uy, M.D. | |
Sub-Investigator: Ravi Vij, M.D. | |
Sub-Investigator: Matthew Walter, M.D. | |
Sub-Investigator: Timothy Graubert, M.D. | |
Sub-Investigator: Michael Tomasson, M.D. | |
Sub-Investigator: Amanda Cashen, M.D. | |
Sub-Investigator: Peter Westervelt, M.D., Ph.D. | |
Sub-Investigator: Keith Stockerl-Goldstein, M.D. | |
Sub-Investigator: Kristan Augustin, PharmD |
Principal Investigator: | Camille N. Abboud, M.D. | Washington Univerisity |
Responsible Party: | Washington University School of Medicine ( Camille Abboud, M.D. ) |
Study ID Numbers: | 08-0853 |
Study First Received: | July 30, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00727766 |
Health Authority: | United States: Food and Drug Administration |
Clofarabine Clolar AML Consolidation |
Clofarabine Leukemia Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |