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

Withdrawn before enrolling · Phase 2

Conditions studied: Acute Promyelocytic Leukemia

In brief

The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.

Key facts

Study ID

NCT00670150

Run by

University of Southern California

People needed

0

Starts

2010-05-01

Expected to finish

2010-08-01

Last updated by the study team

2015-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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