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Trial record 57 of 144 for:    "Acute promyelocytic leukemia"

Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia

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ClinicalTrials.gov Identifier: NCT00184054
Recruitment Status : Terminated (Competing studies)
First Posted : September 16, 2005
Results First Posted : July 17, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
University of Southern California

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myelogenous Leukemia
Interventions Drug: Arsenic Trioxide (ATO)
Drug: Ascorbic Acid
Enrollment 11
Recruitment Details Recruitment for this study opened in April 2002 and closed in May 2008. All subjects were seen at USC.
Pre-assignment Details The study has no pre-assignment. All subjects were given the same treatment.
Arm/Group Title Arsenic Trioxide (ATO) Plus Ascorbic Acid
Hide Arm/Group Description All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Arsenic Trioxide (ATO) Plus Ascorbic Acid
Hide Arm/Group Description All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
All participants were included in the analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  36.4%
>=65 years
7
  63.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
5
  45.5%
Male
6
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi)
Hide Description Complete Remission (CR): ANC >=1000/mcl, Platelet count >=100,000/mcl, Bone marrow <5% blasts. Complete Remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Patients who failed to achieve CR or CRi after two cycles were considered treatment failures. Patients who did not complete at least two cycles were not evaluated for response.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least 2 cycles of treatment as part of this study are included in the analysis of response.
Arm/Group Title Arsenic Trioxide (ATO) Plus Ascorbic Acid
Hide Arm/Group Description:
All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
CR 1
CRi 5
Treatment Failure 4
Not Evaluable 1
2.Secondary Outcome
Title Number of Participants With Severe (Grades 3-5) Adverse Events
Hide Description Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses.
Time Frame Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arsenic Trioxide (ATO) Plus Ascorbic Acid
Hide Arm/Group Description:
All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
Anorexia 1
Alanine aminotransferase increased 1
Conjunctivitis infective 2
Differentiation syndrome 1
Electrocardiogram QT corrected interval prolonged 1
Neuropathy: sensory 1
Sepsis 4
Time Frame Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arsenic Trioxide (ATO) Plus Ascorbic Acid
Hide Arm/Group Description All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
All-Cause Mortality
Arsenic Trioxide (ATO) Plus Ascorbic Acid
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arsenic Trioxide (ATO) Plus Ascorbic Acid
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
General disorders   
Differentiation syndrome  1 [1]  1/11 (9.09%)  1
Infections and infestations   
Conjunctivitis infective  1  2/11 (18.18%)  2
Sepsis  1  4/11 (36.36%)  5
Investigations   
Alanine aminotransferase increased  1  1/11 (9.09%)  1
Electrocardiogram QT corrected interval prolonged  1  1/11 (9.09%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/11 (9.09%)  2
Nervous system disorders   
Neuropathy sensory  1  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
Shortness of breath with hypoxia responding to steroids during hyperleukocytosi
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arsenic Trioxide (ATO) Plus Ascorbic Acid
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Gastrointestinal disorders   
Nausea  1  5/11 (45.45%)  10
Vomiting  1  5/11 (45.45%)  10
General disorders   
Localized edema  1  2/11 (18.18%)  2
Fatigue  1  3/11 (27.27%)  3
Infections and infestations   
Cellulitis - hand  1  1/11 (9.09%)  1
Urinary Tract Infection  1  1/11 (9.09%)  1
Investigations   
Electrocardiogram QT corrected interval prolonged  1  1/11 (9.09%)  1
Metabolism and nutrition disorders   
Anorexia  1  2/11 (18.18%)  4
Nervous system disorders   
Headache  1  5/11 (45.45%)  8
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  2/11 (18.18%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Victoria Soto, Project Specialist, Clinical Investigations Support Office
Organization: USC Norris Comprehensive Cancer Center
Phone: 323-226-6384
EMail: victoria.soto@med.usc.edu
Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00184054     History of Changes
Other Study ID Numbers: 9L-02-1
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: June 13, 2014
Results First Posted: July 17, 2014
Last Update Posted: July 25, 2014