- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00670150
New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
October 24, 2015 updated by: University of Southern California
Phase II Study of NRX 195183 Induction and NRX 195183 Combined With Arsenic Trioxide (As2o3) as Initial Consolidation Therapy Followed by Continuous NRX 195183 Maintenance Therapy for Patients With Untreated Acute Promyelocytic Leukemia
The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The primary objectives of this study are in newly diagnosed APL patients:
- To evaluate the efficacy (complete and molecular response rates) and toxicity of NRX 195183 in induction therapy
- To evaluate the efficacy (molecular response rates) and toxicity of NRX 195183 in combination with arsenic trioxide (As2O3) in consolidation therapy.
- To evaluate the efficacy (event free-survival, disease-free survival) and toxicity of NRX 195183 as maintenance therapy for patients with APL who achieve a molecular complete response.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90033
- USC/Norris Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis Patients must have a clinical diagnosis of acute promyelocytic leukemia (APL) morphology or FAB M3 variant confirmed by RT-PCR assay for PML-RARα or chromosome analysis/FISH showing t(15:17) translocation. A patient may be entered prior to confirmatory studies, but a patient who is subsequently found to be PML-RARα negative will be removed from protocol treatment.
- Prior Treatment The patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy, retinoids or arsenic trioxide. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient.
- Age: Patients must be of age eighteen (18) or above.
Other Criteria
Patients must have the following laboratory values:
- 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
Pregnancy / Nursing Status
- 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. treatment. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk of fetal malformation if pregnancy occurs while on treatment in any amount with retinoid drugs even for short periods.
Exclusion Criteria:
- Non-APL, AML patients should be excluded from the study.
- Other serious illnesses which would limit survival to 1 year.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is achieving a partial or complete response
Time Frame: Bone marrow biopsies will be done monthly during induction
|
Bone marrow biopsies will be done monthly during induction
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and feasibility
Time Frame: Twice weekly during induction and then weekly during consolidation
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Twice weekly during induction and then weekly during consolidation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dan Douer, MD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
April 28, 2008
First Submitted That Met QC Criteria
April 29, 2008
First Posted (Estimate)
May 1, 2008
Study Record Updates
Last Update Posted (Estimate)
October 27, 2015
Last Update Submitted That Met QC Criteria
October 24, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9L-07-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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