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Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

This study has been terminated.
(Supporting agency withdrew funding for study.)
Information provided by (Responsible Party):
Jessica Altman, Northwestern University Identifier:
First received: September 25, 2009
Last updated: October 28, 2013
Last verified: October 2013
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.

Condition Intervention Phase
Acute Promyelocytic Leukemia Drug: Tamibarotene Drug: Arsenic trioxide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia

Resource links provided by NLM:

Further study details as provided by Jessica Altman, Northwestern University:

Primary Outcome Measures:
  • 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. ]

Enrollment: 4
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Tamibarotene + Arsenic Trioxide
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00985530

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  More Information

Responsible Party: Jessica Altman, Jessica Altman, MD, Northwestern University Identifier: NCT00985530     History of Changes
Other Study ID Numbers: NU 08H9
NCI-2010-01852 ( Other Identifier: NCI CTRP# )
STU00012159 ( Other Identifier: Northwestern University IRB# )
Study First Received: September 25, 2009
Last Updated: October 28, 2013

Additional relevant MeSH terms:
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic trioxide
Antineoplastic Agents processed this record on September 21, 2017