New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
NCT00670150 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2015-10-27
Summary
The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.
Conditions
- Acute Promyelocytic Leukemia
Interventions
- DRUG
-
NRX 195183 (retinoid analogue)
30mg/m2 PO daily x 3mo.in Induction, then daily with consolidation
- DRUG
-
Arsenic Trioxide
0.15mg/kg/day over 2hrs VI on day 1-5 x 4 weeks. 2 weeks rest then repeat x 3 more cycles.
Sponsors & Collaborators
-
Sponsor Name Pending
collaborator INDUSTRY -
University of Southern California
lead OTHER
Principal Investigators
-
Dan Douer, MD · University of Southern California
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2010-08-31
- Completion
- 2010-08-31
Countries
- United States
Study Locations
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