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Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

NCT ID: NCT00985530

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Promyelocytic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Tamibarotene + Arsenic Trioxide

Group Type EXPERIMENTAL

Tamibarotene

Intervention Type DRUG

Self-administered tablets BID (approximately one hour after breakfast \& dinner) during each 6 week cycle

Arsenic trioxide

Intervention Type DRUG

Administered intravenously Monday thru Friday at 0.15 mg/kg - 30 doses per cycle.

Interventions

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Tamibarotene

Self-administered tablets BID (approximately one hour after breakfast \& dinner) during each 6 week cycle

Intervention Type DRUG

Arsenic trioxide

Administered intravenously Monday thru Friday at 0.15 mg/kg - 30 doses per cycle.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CytRx

INDUSTRY

Sponsor Role collaborator

Cephalon

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Altman

Jessica Altman, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2010-01852

Identifier Type: OTHER

Identifier Source: secondary_id

STU00012159

Identifier Type: OTHER

Identifier Source: secondary_id

NU 08H9

Identifier Type: -

Identifier Source: org_study_id