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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Promyelocytic Leukemia

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Trial Information

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 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.


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-RARĪ± 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-RARĪ±
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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary endpoint is achieving a partial or complete response

Outcome Time Frame:

Bone marrow biopsies will be done monthly during induction

Safety Issue:

No

Principal Investigator

Dan Douer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

9L-07-12

NCT ID:

NCT00670150

Start Date:

May 2010

Completion Date:

May 2011

Related Keywords:

  • Acute Promyelocytic Leukemia
  • Leukemia
  • Leukemia, Promyelocytic, Acute

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800