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A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Promyelocytic Leukemia

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Trial Information

A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Once the MTD has been reached.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

NU 08H9

NCT ID:

NCT00985530

Start Date:

October 2009

Completion Date:

May 2011

Related Keywords:

  • Acute Promyelocytic Leukemia
  • Leukemia
  • Leukemia, Promyelocytic, Acute

Name

Location

Northwestern UniversityChicago, Illinois  60611