Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
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ClinicalTrials.gov Identifier: NCT00985530 |
Recruitment Status
:
Terminated
(Supporting agency withdrew funding for study.)
First Posted
: September 28, 2009
Last Update Posted
: October 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Promyelocytic Leukemia | Drug: Tamibarotene Drug: Arsenic trioxide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
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.
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- 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. ]

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985530
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Responsible Party: | Jessica Altman, Jessica Altman, MD, Northwestern University |
ClinicalTrials.gov Identifier: | NCT00985530 History of Changes |
Other Study ID Numbers: |
NU 08H9 NCI-2010-01852 ( Other Identifier: NCI CTRP# ) STU00012159 ( Other Identifier: Northwestern University IRB# ) |
First Posted: | September 28, 2009 Key Record Dates |
Last Update Posted: | October 30, 2013 |
Last Verified: | October 2013 |
Additional relevant MeSH terms:
Leukemia Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms |
Leukemia, Myeloid, Acute Leukemia, Myeloid Arsenic trioxide Antineoplastic Agents |