Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
1 other identifier
interventional
65
1 country
1
Brief Summary
The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
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
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedMay 12, 2008
May 1, 2008
2 years
May 7, 2008
May 9, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Remission
90 Days
Secondary Outcomes (1)
Molecular Complete Remission
9 months
Study Arms (1)
1
EXPERIMENTALInterventions
Daily oral NRX 195183 administration for 90 days to assess CR rate. Patients with CR may continue maintenance therapy after a 2-week drug holiday. Maintenance therapy will consist of two 3-month daily oral NRX 195183 administration separated by a 2-week drug holiday.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of APL morphology or FAB M3 variant confirmed by RT-PCR assay or chromosome analysis/FISH showing t(15:17) translocation. Patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies:
- ATRA
- Cytotoxic chemotherapy
- Arsenic trioxide
- Patients must be 18 or older.
- Bilirubin equal or less than 1.5 times the upper limit of normal.
- Creatinine equal or less than 1.5 times the upper limit of normal.
- Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk that a severely deformed infant will result if NRX 195183 is administered during pregnancy.
You may not qualify if:
- Non-APL, AML patients should be excluded from the study.
- Other serious illnesses which would limit survival to 6 months.
- Psychiatric conditions which would prevent compliance with treatment or informed consent.
- Uncontrolled or severe cardiovascular disease. This would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
- AIDS or HIV positive patients, although HIV test is not required for accrual.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2008
First Posted
May 12, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2010
Last Updated
May 12, 2008
Record last verified: 2008-05