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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Promyelocytic Leukemia

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Remission

Outcome Time Frame:

90 Days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

195183-202

NCT ID:

NCT00675870

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Acute Promyelocytic Leukemia
  • Acute Promyelocytic Leukemia
  • Cancer
  • Leukemia
  • APL
  • ATRA
  • Tretinoid
  • Vesanoid
  • Retinoic Acid Receptor Alpha
  • All Trans Retinoic Acid
  • Arsenic Trioxide
  • Trisenox
  • Retinoid
  • Relapsed or Refractory Acute Promyelocytic Leukemia
  • Leukemia
  • Leukemia, Promyelocytic, Acute

Name

Location

Sarcoma Oncology CenterSanta Monica, California  90403