Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

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Brief Title

Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

Official Title

Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

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
    

Detailed Description

      A common current therapeutic approach to APL uses oral ATRA and chemotherapy in induction and
      consolidation. This approach has significantly improved survival in newly diagnosed APL
      patients. However, approximately 30% of patients relapse. Recently, an approach involving the
      combination of oral ATRA and arsenic trioxide has been tested. The prognosis for relapsed
      patients is very poor. This study seeks to investigate NRX 195183 monotherapy in patients who
      have failed or are resistant to or are intolerant of any prior therapy.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete Remission

Secondary Outcome

 Molecular Complete Remission

Condition

Acute Promyelocytic Leukemia

Intervention

NRX 195183 Soft Gelatin Capsule

Study Arms / Comparison Groups

 1
Description:  

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

65

Start Date

April 2008


Primary Completion Date

April 2010

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 949-336-7111, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00675870

Organization ID

195183-202



Study Sponsor

NuRx Pharmaceuticals, Inc.


Study Sponsor

, , 


Verification Date

May 2008