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Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00985530
Recruitment Status : Terminated (Supporting agency withdrew funding for study.)
First Posted : September 28, 2009
Last Update Posted : October 30, 2013
Information provided by (Responsible Party):
Jessica Altman, Northwestern University

September 25, 2009
September 28, 2009
October 30, 2013
October 2009
May 2011   (Final data collection date for primary outcome measure)
To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL. [ Time Frame: Once the MTD has been reached. ]
Same as current
Complete list of historical versions of study NCT00985530 on Archive Site
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Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia
Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an investigational drug called Tamibarotene in combination with standard treatment for relapsed APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of this study is to determine if tamibarotene in combination with arsenic trioxide is safe and effective.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Promyelocytic Leukemia
  • Drug: Tamibarotene
    Self-administered tablets BID (approximately one hour after breakfast & dinner) during each 6 week cycle
  • Drug: Arsenic trioxide
    Administered intravenously Monday thru Friday at 0.15 mg/kg - 30 doses per cycle.
Experimental: Arm 1
Tamibarotene + Arsenic Trioxide
  • Drug: Tamibarotene
  • Drug: Arsenic trioxide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have diagnosis of relapsed APL
  • Must have completed any prior cancer treatment at least 6 months prior to study
  • Must have had prior treatment that included ATRA
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NU 08H9
NCI-2010-01852 ( Other Identifier: NCI CTRP# )
STU00012159 ( Other Identifier: Northwestern University IRB# )
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Jessica Altman, Northwestern University
Northwestern University
  • CytRx
  • Cephalon
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Northwestern University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP