Trial Outcomes & Findings for Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia (NCT NCT00184054)

Last Updated: 2014-07-25

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2014-07-25

Participant Flow

Recruitment for this study opened in April 2002 and closed in May 2008. All subjects were seen at USC.

The study has no pre-assignment. All subjects were given the same treatment.

Participant milestones

Participant milestones
Measure	Arsenic Trioxide (ATO) Plus Ascorbic Acid 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 Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arsenic Trioxide (ATO) Plus Ascorbic Acid 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 Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arsenic Trioxide (ATO) Plus Ascorbic Acid n=11 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: All subjects who received at least 2 cycles of treatment as part of this study are included in the analysis of response.

Outcome measures

Outcome measures
Measure	Arsenic Trioxide (ATO) Plus Ascorbic Acid n=11 Participants 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
Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) CR	1 participants
Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) CRi	5 participants
Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) Treatment Failure	4 participants
Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) Not Evaluable	1 participants

SECONDARY outcome

Timeframe: 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)

Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses.

Outcome measures

Outcome measures
Measure	Arsenic Trioxide (ATO) Plus Ascorbic Acid n=11 Participants 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
Number of Participants With Severe (Grades 3-5) Adverse Events Anorexia	1 Participants
Number of Participants With Severe (Grades 3-5) Adverse Events Alanine aminotransferase increased	1 Participants
Number of Participants With Severe (Grades 3-5) Adverse Events Conjunctivitis infective	2 Participants
Number of Participants With Severe (Grades 3-5) Adverse Events Differentiation syndrome	1 Participants
Number of Participants With Severe (Grades 3-5) Adverse Events Electrocardiogram QT corrected interval prolonged	1 Participants
Number of Participants With Severe (Grades 3-5) Adverse Events Neuropathy: sensory	1 Participants
Number of Participants With Severe (Grades 3-5) Adverse Events Sepsis	4 Participants

Adverse Events

Arsenic Trioxide (ATO) Plus Ascorbic Acid

Serious events: 11 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arsenic Trioxide (ATO) Plus Ascorbic Acid n=11 participants at risk 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
Metabolism and nutrition disorders Anorexia	9.1% 1/11 • Number of events 2 • 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)
Investigations Alanine aminotransferase increased	9.1% 1/11 • Number of events 1 • 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)
Infections and infestations Conjunctivitis infective	18.2% 2/11 • Number of events 2 • 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)
General disorders Differentiation syndrome	9.1% 1/11 • Number of events 1 • 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)
Investigations Electrocardiogram QT corrected interval prolonged	9.1% 1/11 • Number of events 1 • 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)
Nervous system disorders Neuropathy sensory	9.1% 1/11 • Number of events 1 • 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)
Infections and infestations Sepsis	36.4% 4/11 • Number of events 5 • 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)

Other adverse events

Other adverse events
Measure	Arsenic Trioxide (ATO) Plus Ascorbic Acid n=11 participants at risk 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
Metabolism and nutrition disorders Anorexia	18.2% 2/11 • Number of events 4 • 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)
Infections and infestations Cellulitis - hand	9.1% 1/11 • Number of events 1 • 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)
General disorders Localized edema	18.2% 2/11 • Number of events 2 • 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)
Investigations Electrocardiogram QT corrected interval prolonged	9.1% 1/11 • Number of events 1 • 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)
General disorders Fatigue	27.3% 3/11 • Number of events 3 • 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)
Nervous system disorders Headache	45.5% 5/11 • Number of events 8 • 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)
Gastrointestinal disorders Nausea	45.5% 5/11 • Number of events 10 • 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)
Skin and subcutaneous tissue disorders Rash maculo-papular	18.2% 2/11 • Number of events 2 • 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)
Infections and infestations Urinary Tract Infection	9.1% 1/11 • Number of events 1 • 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)
Gastrointestinal disorders Vomiting	45.5% 5/11 • Number of events 10 • 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)

Additional Information

Victoria Soto, Project Specialist, Clinical Investigations Support Office

USC Norris Comprehensive Cancer Center

Phone: 323-226-6384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place