NCT00985530

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

September 25, 2009

Last Update Submit

October 28, 2013

Conditions

Acute Promyelocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.

    Once the MTD has been reached.

Study Arms (1)

Arm 1

EXPERIMENTAL

Tamibarotene + Arsenic Trioxide

Drug: TamibaroteneDrug: Arsenic trioxide

Interventions

TamibaroteneDRUG

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

Arm 1
Arsenic trioxideDRUG

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

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

tamibaroteneArsenic Trioxide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jessica Altman, MD

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

US(1)