Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

Northwestern University

Status and phase: Terminated; Phase 1

Conditions: Acute Promyelocytic Leukemia

Treatments: Drug: Arsenic trioxide; Drug: Tamibarotene

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00985530

STU00012159 (Other Identifier)

NCI-2010-01852 (Other Identifier)

NU 08H9

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Arm 1

Experimental group

Description:

Tamibarotene + Arsenic Trioxide

Treatment:

Drug: Tamibarotene

Drug: Arsenic trioxide