Back to resultsNew Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
Primary Purpose
Acute Promyelocytic Leukemia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NRX 195183 (retinoid analogue)
Arsenic Trioxide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Promyelocytic Leukemia
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.
Sites / Locations
- USC/Norris Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
The primary endpoint is achieving a partial or complete response
Secondary Outcome Measures
Safety and feasibility
Full Information
NCT ID
NCT00670150
First Posted
April 28, 2008
Last Updated
October 24, 2015
Sponsor
University of Southern California
Collaborators
Sponsor Name Pending
1. Study Identification
Unique Protocol Identification Number
NCT00670150
Brief Title
New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
sponsor withdrew support
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Southern California
Collaborators
Sponsor Name Pending
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Promyelocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NRX 195183 (retinoid analogue)
Intervention Description
30mg/m2 PO daily x 3mo.in Induction, then daily with consolidation
Intervention Type
Drug
Intervention Name(s)
Arsenic Trioxide
Intervention Description
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 Measure Information:
Title
The primary endpoint is achieving a partial or complete response
Time Frame
Bone marrow biopsies will be done monthly during induction
Secondary Outcome Measure Information:
Title
Safety and feasibility
Time Frame
Twice weekly during induction and then weekly during consolidation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Douer, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
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