Trial Outcomes & Findings for Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia (NCT NCT00528450)
NCT ID: NCT00528450
Last Updated: 2016-01-29
Results Overview
\# of patients with Complete Remission
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-29
Participant Flow
Participant milestones
| Measure |
All Patients
Tretinoin and Arsenic Trioxide With or Without Idarubicin
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia
Baseline characteristics by cohort
| Measure |
All Patients
n=1 Participants
Tretinoin and Arsenic Trioxide With or Without Idarubicin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years\# of patients with Complete Remission
Outcome measures
| Measure |
All Patients
n=1 Participants
Tretinoin and Arsenic Trioxide With or Without Idarubicin
|
|---|---|
|
Molecular Remission Rate
|
1 participants
|
Adverse Events
All Patients
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Patients
n=1 participants at risk
Tretinoin and Arsenic Trioxide With or Without Idarubicin
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
AST, SGOT
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
Infection, other
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
1/1 • Number of events 1
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Pain - Head/headache
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Pain - Pain NOS
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1
|
Additional Information
Dr. Peter Maslak
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place