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

NCT ID: NCT00670150

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-08-31

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.

Conditions

Acute Promyelocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

NRX 195183 (retinoid analogue)

30mg/m2 PO daily x 3mo.in Induction, then daily with consolidation

Intervention Type: DRUG

Arsenic Trioxide

0.15mg/kg/day over 2hrs VI on day 1-5 x 4 weeks. 2 weeks rest then repeat x 3 more cycles.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sponsor Name Pending

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

University of Southern California

Principal Investigators

Dan Douer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

9L-07-12

Identifier Type: -

Identifier Source: org_study_id