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Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00528450
Recruitment Status : Terminated (Lack of accrual)
First Posted : September 12, 2007
Results First Posted : January 29, 2016
Last Update Posted : January 29, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cephalon
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: arsenic trioxide
Drug: idarubicin
Drug: tretinoin
Enrollment 1

Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Tretinoin and Arsenic Trioxide With or Without Idarubicin
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description Tretinoin and Arsenic Trioxide With or Without Idarubicin
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Molecular Remission Rate
Hide Description # of patients with Complete Remission
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Tretinoin and Arsenic Trioxide With or Without Idarubicin
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Tretinoin and Arsenic Trioxide With or Without Idarubicin
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
ALT, SGPT  1  1/1 (100.00%)  1
AST, SGOT  1  1/1 (100.00%)  1
Hemoglobin  1  1/1 (100.00%)  1
Leukocytes (total WBC)  1  1/1 (100.00%)  1
Lymphopenia  1  1/1 (100.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%)  1
Platelets  1  1/1 (100.00%)  1
Gastrointestinal disorders   
Vomiting  1  1/1 (100.00%)  1
General disorders   
Pain - Head/headache  1  1/1 (100.00%)  1
Pain - Pain NOS  1  1/1 (100.00%)  1
Infections and infestations   
Infection, other  1  1/1 (100.00%)  1
Metabolism and nutrition disorders   
Alkaline phosphatase  1  1/1 (100.00%)  1
Bilirubin (hyperbilirubinemia)  1  1/1 (100.00%)  1
Glucose, high (hyperglycemia)  1  1/1 (100.00%)  1
Phosphate, low (hypophosphatemia)  1  1/1 (100.00%)  1
Potassium, high (hyperkalemia)  1  1/1 (100.00%)  1
Nervous system disorders   
Dizziness  1  1/1 (100.00%)  1
Psychiatric disorders   
Mood alteration - Anxiety  1  1/1 (100.00%)  1
Skin and subcutaneous tissue disorders   
Pruritus/itching  1  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Peter Maslak
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5518
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00528450     History of Changes
Other Study ID Numbers: 07-108
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07108
CEPHALONO-MSKCC-07108
First Submitted: September 10, 2007
First Posted: September 12, 2007
Results First Submitted: December 23, 2015
Results First Posted: January 29, 2016
Last Update Posted: January 29, 2016