New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia

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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