Trial Outcomes & Findings for Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy (NCT NCT01404949)
NCT ID: NCT01404949
Last Updated: 2021-11-30
Results Overview
after induction with combined tretinoin and ATO (along with idarubicin in patients with high-risk disease or who develop leukocytosis) in APL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
4 years
Results posted on
2021-11-30
Participant Flow
Participant milestones
| Measure |
Tretinoin and Arsenic Trioxide
This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.
Tretinoin and Arsenic Trioxide: See Detailed Description
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|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tretinoin and Arsenic Trioxide
This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.
Tretinoin and Arsenic Trioxide: See Detailed Description
|
|---|---|
|
Overall Study
Not Treated
|
1
|
Baseline Characteristics
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
Baseline characteristics by cohort
| Measure |
Tretinoin and Arsenic Trioxide
n=17 Participants
This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.
Tretinoin and Arsenic Trioxide: See Detailed Description
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Data were not collected
after induction with combined tretinoin and ATO (along with idarubicin in patients with high-risk disease or who develop leukocytosis) in APL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsafter induction with tretinoin and ATO (with idarubicin in patients with high-risk disease or who develop leukocytosis).
Outcome measures
| Measure |
Tretinoin and Arsenic Trioxide
n=16 Participants
This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.
Tretinoin and Arsenic Trioxide: See Detailed Description
|
|---|---|
|
Participants Who Experienced a Complete Remission
|
16 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Data were not collected
after each course of postremission therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Data were not collected
treated with this program.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Data were not collected
including the early death rate (within 30 days), the incidence of APL differentiation syndrome, the number and length of hospitalizations, the incidence of secondary myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), and the effects of treatment on left ventricular ejection fraction (LVEF) Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be tabulated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Data were not collected
with combined tretinoin and ATO using serial immunophenotyping studies of peripheral blood
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Data were not collected
by ATRA (Tretinoin) and ATO (Arsenic Trioxide). Bone marrow samples will be analyzed at baseline and at the time of clinical CR for telomerase activity, telomere length and TERT expression
Outcome measures
Outcome data not reported
Adverse Events
Tretinoin and Arsenic Trioxide
Serious events: 7 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Tretinoin and Arsenic Trioxide
n=17 participants at risk
This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.
Tretinoin and Arsenic Trioxide: See Detailed Description
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • 1 year
|
|
Cardiac disorders
Chest pain - cardiac
|
5.9%
1/17 • 1 year
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • 1 year
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • 1 year
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.9%
1/17 • 1 year
|
|
General disorders
Fever
|
35.3%
6/17 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
1/17 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
1/17 • 1 year
|
|
Infections and infestations
Skin infection
|
5.9%
1/17 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • 1 year
|
Other adverse events
| Measure |
Tretinoin and Arsenic Trioxide
n=17 participants at risk
This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.
Tretinoin and Arsenic Trioxide: See Detailed Description
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.5%
4/17 • 1 year
|
|
General disorders
Fatigue
|
23.5%
4/17 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.5%
4/17 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
23.5%
4/17 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
3/17 • 1 year
|
|
Eye disorders
Eye disorders - Other, specify
|
17.6%
3/17 • 1 year
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.6%
3/17 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
11.8%
2/17 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
11.8%
2/17 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
11.8%
2/17 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
2/17 • 1 year
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
11.8%
2/17 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
11.8%
2/17 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
2/17 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
2/17 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.8%
2/17 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
11.8%
2/17 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
11.8%
2/17 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
11.8%
2/17 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disordered Others, spec
|
11.8%
2/17 • 1 year
|
|
Investigations
Weight loss
|
11.8%
2/17 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • 1 year
|
|
Investigations
Alanine aminotransferase increase
|
5.9%
1/17 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
1/17 • 1 year
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • 1 year
|
|
Injury, poisoning and procedural complications
Bruising
|
5.9%
1/17 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.9%
1/17 • 1 year
|
|
Eye disorders
Cataract
|
5.9%
1/17 • 1 year
|
|
Investigations
Cholesterol high
|
5.9%
1/17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • 1 year
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • 1 year
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • 1 year
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • 1 year
|
|
General disorders
Edema limbs
|
5.9%
1/17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • 1 year
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.9%
1/17 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.9%
1/17 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • 1 year
|
|
General disorders
Gen disorders & admin site conditions Other, spec
|
5.9%
1/17 • 1 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.9%
1/17 • 1 year
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
1/17 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • 1 year
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • 1 year
|
|
Investigations
Investigation - Other, specify
|
5.9%
1/17 • 1 year
|
|
Nervous system disorders
Lethargy
|
5.9%
1/17 • 1 year
|
|
Blood and lymphatic system disorders
Lymph node pain
|
5.9%
1/17 • 1 year
|
|
Cardiac disorders
Myocarditis
|
5.9%
1/17 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
1/17 • 1 year
|
|
Nervous system disorders
Paresthesia
|
5.9%
1/17 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
1/17 • 1 year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.9%
1/17 • 1 year
|
|
Investigations
Platelet count decreased
|
5.9%
1/17 • 1 year
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
5.9%
1/17 • 1 year
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.9%
1/17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.9%
1/17 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.9%
1/17 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
5.9%
1/17 • 1 year
|
|
Vascular disorders
Superficial thrombophlebitis
|
5.9%
1/17 • 1 year
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
5.9%
1/17 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
5.9%
1/17 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
5.9%
1/17 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • 1 year
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
5.9%
1/17 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • 1 year
|
|
Investigations
White blood cell decreased
|
5.9%
1/17 • 1 year
|
Additional Information
Dr. Jae Park, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place