Brief Title
New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
Official Title
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
Brief Summary
The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated
APL will be assessed.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
The primary endpoint is achieving a partial or complete response
Secondary Outcome
Safety and feasibility
Condition
Acute Promyelocytic Leukemia
Intervention
NRX 195183 (retinoid analogue)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
May 2010
Completion Date
August 2010
Primary Completion Date
August 2010
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Dan Douer, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00670150
Organization ID
9L-07-12
Study Sponsor
University of Southern California
Collaborators
Sponsor Name Pending
Study Sponsor
Dan Douer, MD, Principal Investigator, University of Southern California
Verification Date
October 2015