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Trial record 17 of 144 for:    "Acute promyelocytic leukemia"

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.
 
ClinicalTrials.gov Identifier: NCT00670150
Recruitment Status : Withdrawn (sponsor withdrew support)
First Posted : May 1, 2008
Last Update Posted : October 27, 2015
Sponsor:
Collaborator:
Sponsor Name Pending
Information provided by:
University of Southern California

Tracking Information
First Submitted Date  ICMJE April 28, 2008
First Posted Date  ICMJE May 1, 2008
Last Update Posted Date October 27, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
The primary endpoint is achieving a partial or complete response [ Time Frame: Bone marrow biopsies will be done monthly during induction ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00670150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Safety and feasibility [ Time Frame: Twice weekly during induction and then weekly during consolidation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Promyelocytic Leukemia
Intervention  ICMJE
  • Drug: NRX 195183 (retinoid analogue)
    30mg/m2 PO daily x 3mo.in 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2008)
45
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00670150
Other Study ID Numbers  ICMJE 9L-07-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Dan Douer, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Sponsor Name Pending
Investigators  ICMJE
Principal Investigator: Dan Douer, MD University of Southern California
PRS Account University of Southern California
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP