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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00670150
Recruitment Status : Withdrawn (sponsor withdrew support)
First Posted : May 1, 2008
Last Update Posted : October 27, 2015
Sponsor Name Pending
Information provided by:
University of Southern California

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

Condition or disease Intervention/treatment Phase
Acute Promyelocytic Leukemia Drug: NRX 195183 (retinoid analogue) Drug: Arsenic Trioxide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Intervention Details:
  • Drug: NRX 195183 (retinoid analogue)
    30mg/m2 PO daily x Induction, then daily with consolidation
  • 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.

Primary Outcome Measures :
  1. The primary endpoint is achieving a partial or complete response [ Time Frame: Bone marrow biopsies will be done monthly during induction ]

Secondary Outcome Measures :
  1. Safety and feasibility [ Time Frame: Twice weekly during induction and then weekly during consolidation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00670150

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United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Sponsor Name Pending
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Principal Investigator: Dan Douer, MD University of Southern California

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Responsible Party: Dr. Dan Douer, University of Southern California Identifier: NCT00670150     History of Changes
Other Study ID Numbers: 9L-07-12
First Posted: May 1, 2008    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic Trioxide
Antineoplastic Agents