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Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01522976
Recruitment Status : Active, not recruiting
First Posted : February 1, 2012
Results First Posted : March 22, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myelomonocytic Leukemia
Chronic Myelomonocytic Leukemia-1
Chronic Myelomonocytic Leukemia-2
Myelodysplastic Syndrome
Myelodysplastic Syndrome With Excess Blasts
Myelodysplastic Syndrome With Excess Blasts-1
Myelodysplastic Syndrome With Excess Blasts-2
Previously Treated Myelodysplastic Syndrome
Interventions Drug: Azacitidine
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Vorinostat
Enrollment 282
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Period Title: Overall Study
Started 97 92 93
Completed 0 0 0
Not Completed 97 92 93
Reason Not Completed
Ineligible             4             0             1
Death             7             6             2
Still on treatment             9             9             6
Disease progression             28             30             25
Adverse Event             17             7             18
Refusal unrelated to adverse event             10             13             14
Not protocol specified             22             27             27
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat Total
Hide Arm/Group Description

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Total of all reporting groups
Overall Number of Baseline Participants 93 92 92 277
Hide Baseline Analysis Population Description
Analysis includes eligible patients only.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 93 participants 92 participants 92 participants 277 participants
70.81
(51.29 to 86.68)
69.67
(42.69 to 88.96)
70.36
(28.69 to 93.01)
70.18
(28.69 to 93.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 92 participants 92 participants 277 participants
Female
32
  34.4%
31
  33.7%
22
  23.9%
85
  30.7%
Male
61
  65.6%
61
  66.3%
70
  76.1%
192
  69.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 92 participants 92 participants 277 participants
American Indian or Alaska Native
1
   1.1%
0
   0.0%
1
   1.1%
2
   0.7%
Asian
1
   1.1%
4
   4.3%
2
   2.2%
7
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.1%
1
   0.4%
Black or African American
2
   2.2%
3
   3.3%
4
   4.3%
9
   3.2%
White
86
  92.5%
80
  87.0%
83
  90.2%
249
  89.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   3.2%
5
   5.4%
1
   1.1%
9
   3.2%
1.Primary Outcome
Title Response Rate (Phase II)
Hide Description A response is any of complete hematological remission, partial remission, or hematologic improvement.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes eligible patients only.
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description:

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Overall Number of Participants Analyzed 93 92 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients having a response
49
(39 to 60)
38
(28 to 49)
27
(18 to 37)
2.Primary Outcome
Title Overall Survival (Phase III)
Hide Description OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This trial did not proceed to the Phase III portion. Therefore, no patients were analyzed for this outcome measure.
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description:

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Relapse-free Survival
Hide Description RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes eligible patients who had a response.
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description:

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Overall Number of Participants Analyzed 46 35 25
Median (95% Confidence Interval)
Unit of Measure: Days
435
(237 to 546)
311
(182 to 640)
455 [1] 
(197 to NA)
[1]
The upper limit of the confidence interval cannot be estimated.
4.Secondary Outcome
Title Overall Survival
Hide Description OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow- up for patients last known to be alive is censored at the date of last contact. OS will be estimated for each of the three arms using the Kaplan-Meier method.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes eligible patients only.
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description:

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Overall Number of Participants Analyzed 93 92 92
Median (95% Confidence Interval)
Unit of Measure: Days
588
(426 to 737)
449
(356 to 603)
527
(392 to 852)
5.Secondary Outcome
Title Pre-study Cytogenetic Abnormalities
Hide Description Cytogenetic risk group is used to identify cytogenetic abnormalities.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes eligible patients only.
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description:

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Overall Number of Participants Analyzed 93 92 92
Measure Type: Number
Unit of Measure: participants
Good/very good 35 29 34
Intermediate 13 16 18
Poor 8 10 8
Very poor 23 23 19
Missing 14 14 13
6.Secondary Outcome
Title Toxicity Rate
Hide Description Adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes only eligible patients who also received treatment.
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description:
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
Overall Number of Participants Analyzed 89 91 91
Measure Type: Number
Unit of Measure: Participants
Abdominal infection 1 0 0
Abdominal pain 1 0 3
Acute kidney injury 0 0 1
Adult respiratory distress syndrome 1 0 0
Alanine aminotransferase increased 0 0 5
Anemia 48 37 44
Anorectal infection 0 0 1
Anorexia 4 0 3
Apnea 0 0 1
Ascites 1 0 1
Aspartate aminotransferase increased 0 0 3
Ataxia 0 0 1
Back pain 1 0 0
Blood and lymphatic system disorders - Other 0 2 1
Blood bilirubin increased 0 0 3
Bronchial infection 0 0 1
CD4 lymphocytes decreased 1 0 0
Cardiac arrest 1 0 0
Catheter related infection 1 2 1
Cecal infection 0 0 1
Cholecystitis 0 0 1
Colitis 0 0 1
Confusion 0 0 1
Constipation 2 1 1
Creatinine increased 2 0 0
Dehydration 5 1 3
Delirium 0 0 1
Diarrhea 5 0 3
Dizziness 1 0 0
Dyspnea 4 2 3
Epistaxis 0 0 1
Esophageal pain 0 0 1
Esophagitis 1 0 0
Fall 0 0 1
Fatigue 9 6 14
Febrile neutropenia 16 11 13
Fever 0 0 2
Flushing 0 0 1
Gastric hemorrhage 0 0 1
Gastrointestinal pain 1 0 1
General disorders and admin site conditions-Other 1 0 0
Generalized muscle weakness 3 1 3
Hallucinations 0 0 1
Headache 0 0 1
Heart failure 0 0 1
Hematoma 0 0 1
Hematuria 1 0 2
Hyperglycemia 1 1 2
Hypernatremia 0 1 0
Hypertension 1 0 2
Hyperuricemia 0 0 1
Hypoalbuminemia 3 0 0
Hypokalemia 4 0 1
Hypomagnesemia 1 0 0
Hyponatremia 5 1 4
Hypophosphatemia 1 0 2
Hypotension 4 0 3
Hypoxia 0 0 1
Infections and infestations - Other, specify 4 2 5
Intracranial hemorrhage 1 0 0
Investigations - Other, specify 1 0 0
Leukocytosis 0 1 0
Lower gastrointestinal hemorrhage 0 0 2
Lung infection 4 1 2
Lymphocyte count decreased 14 9 3
Lymphocyte count increased 0 1 1
Mucosal infection 0 0 1
Mucositis oral 1 0 0
Nausea 1 2 2
Neutrophil count decreased 69 48 63
Pain 1 0 0
Papulopustular rash 1 0 0
Pericardial effusion 1 0 0
Platelet count decreased 61 46 64
Pneumonitis 0 0 1
Pruritus 1 0 0
Pulmonary edema 0 0 1
Purpura 1 0 0
Rash maculo-papular 13 3 1
Renal and urinary disorders - Other, specify 0 0 1
Respiratory failure 0 0 1
Sepsis 4 2 3
Sinus bradycardia 1 0 0
Skin infection 3 1 2
Soft tissue infection 1 1 0
Sudden death NOS 0 1 0
Syncope 2 0 4
Thromboembolic event 1 0 1
Tooth infection 0 0 1
Upper gastrointestinal hemorrhage 0 0 1
Upper respiratory infection 0 1 0
Urinary tract infection 1 1 1
Vascular disorders - Other, specify 0 0 1
Vomiting 1 1 1
Weight loss 1 0 0
White blood cell decreased 48 34 44
Time Frame Up to 5 years
Adverse Event Reporting Description Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
 
Arm/Group Title Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Hide Arm/Group Description Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
All-Cause Mortality
Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/89 (41.57%)   8/91 (8.79%)   47/91 (51.65%) 
Blood and lymphatic system disorders       
Anemia  1  6/89 (6.74%)  0/91 (0.00%)  6/91 (6.59%) 
Blood and lymphatic system disorders - Other  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Febrile neutropenia  1  6/89 (6.74%)  1/91 (1.10%)  2/91 (2.20%) 
Cardiac disorders       
Atrial fibrillation  1  4/89 (4.49%)  0/91 (0.00%)  0/91 (0.00%) 
Atrioventricular block first degree  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Cardiac arrest  1  1/89 (1.12%)  1/91 (1.10%)  0/91 (0.00%) 
Chest pain - cardiac  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Heart failure  1  1/89 (1.12%)  0/91 (0.00%)  2/91 (2.20%) 
Myocardial infarction  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Pericardial effusion  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Sinus bradycardia  1  2/89 (2.25%)  0/91 (0.00%)  2/91 (2.20%) 
Sinus tachycardia  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Ventricular arrhythmia  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Ventricular tachycardia  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Endocrine disorders       
Adrenal insufficiency  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/89 (0.00%)  0/91 (0.00%)  5/91 (5.49%) 
Ascites  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Colitis  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Constipation  1  1/89 (1.12%)  0/91 (0.00%)  2/91 (2.20%) 
Dental caries  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Dysphagia  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Enterocolitis  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Esophageal pain  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Gastric hemorrhage  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Gastrointestinal disorders-Other  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Gastrointestinal pain  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Ileus  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Jejunal hemorrhage  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Lower gastrointestinal hemorrhage  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Mucositis oral  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Nausea  1  1/89 (1.12%)  0/91 (0.00%)  2/91 (2.20%) 
Small intestinal obstruction  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Upper gastrointestinal hemorrhage  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Vomiting  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
General disorders       
Death NOS  1  0/89 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Edema limbs  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Fatigue  1  1/89 (1.12%)  0/91 (0.00%)  4/91 (4.40%) 
Fever  1  1/89 (1.12%)  0/91 (0.00%)  6/91 (6.59%) 
Infusion related reaction  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Malaise  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Non-cardiac chest pain  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Pain  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Sudden death NOS  1  0/89 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Hepatobiliary disorders-Other  1  2/89 (2.25%)  0/91 (0.00%)  0/91 (0.00%) 
Immune system disorders       
Allergic reaction  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Infections and infestations       
Abdominal infection  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Anorectal infection  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Bronchial infection  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Catheter related infection  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Infections and infestations-Other  1  4/89 (4.49%)  0/91 (0.00%)  8/91 (8.79%) 
Lip infection  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Lung infection  1  5/89 (5.62%)  0/91 (0.00%)  4/91 (4.40%) 
Mucosal infection  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Sepsis  1  4/89 (4.49%)  2/91 (2.20%)  4/91 (4.40%) 
Skin infection  1  2/89 (2.25%)  0/91 (0.00%)  1/91 (1.10%) 
Soft tissue infection  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Tooth infection  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Urinary tract infection  1  0/89 (0.00%)  1/91 (1.10%)  3/91 (3.30%) 
Injury, poisoning and procedural complications       
Fracture  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Investigations       
Alanine aminotransferase increased  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Aspartate aminotransferase increased  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Blood bilirubin increased  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Cardiac troponin I increased  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Creatinine increased  1  2/89 (2.25%)  0/91 (0.00%)  2/91 (2.20%) 
Investigations-Other  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Lymphocyte count increased  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Neutrophil count decreased  1  2/89 (2.25%)  0/91 (0.00%)  4/91 (4.40%) 
Platelet count decreased  1  7/89 (7.87%)  0/91 (0.00%)  8/91 (8.79%) 
White blood cell decreased  1  3/89 (3.37%)  0/91 (0.00%)  2/91 (2.20%) 
Metabolism and nutrition disorders       
Anorexia  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Dehydration  1  3/89 (3.37%)  0/91 (0.00%)  2/91 (2.20%) 
Hyperglycemia  1  2/89 (2.25%)  0/91 (0.00%)  2/91 (2.20%) 
Hypoalbuminemia  1  2/89 (2.25%)  0/91 (0.00%)  0/91 (0.00%) 
Hypocalcemia  1  2/89 (2.25%)  0/91 (0.00%)  0/91 (0.00%) 
Hypokalemia  1  4/89 (4.49%)  0/91 (0.00%)  0/91 (0.00%) 
Hypomagnesemia  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Hyponatremia  1  4/89 (4.49%)  0/91 (0.00%)  2/91 (2.20%) 
Hypophosphatemia  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Metabolism and nutrition disorders - Other, specify  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Generalized muscle weakness  1  2/89 (2.25%)  0/91 (0.00%)  3/91 (3.30%) 
Neck pain  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified - Other  1  2/89 (2.25%)  0/91 (0.00%)  0/91 (0.00%) 
Nervous system disorders       
Dizziness  1  2/89 (2.25%)  0/91 (0.00%)  1/91 (1.10%) 
Headache  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Intracranial hemorrhage  1  2/89 (2.25%)  1/91 (1.10%)  0/91 (0.00%) 
Nervous system disorders-Other  1  0/89 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Presyncope  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Stroke  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Syncope  1  1/89 (1.12%)  0/91 (0.00%)  4/91 (4.40%) 
Psychiatric disorders       
Confusion  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Delirium  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Hallucinations  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Renal and urinary disorders       
Acute kidney injury  1  2/89 (2.25%)  0/91 (0.00%)  1/91 (1.10%) 
Chronic kidney disease  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Hematuria  1  1/89 (1.12%)  0/91 (0.00%)  2/91 (2.20%) 
Renal and urinary disorders-Other  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Renal calculi  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Cough  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Dyspnea  1  6/89 (6.74%)  0/91 (0.00%)  2/91 (2.20%) 
Epistaxis  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Hypoxia  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Laryngeal hemorrhage  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Pleural effusion  1  0/89 (0.00%)  0/91 (0.00%)  2/91 (2.20%) 
Pneumonitis  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Pulmonary edema  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Resp, thoracic and mediastinal disorders - Other  1  1/89 (1.12%)  0/91 (0.00%)  0/91 (0.00%) 
Respiratory failure  1  1/89 (1.12%)  0/91 (0.00%)  2/91 (2.20%) 
Skin and subcutaneous tissue disorders       
Rash maculo-papular  1  4/89 (4.49%)  0/91 (0.00%)  0/91 (0.00%) 
Skin and subcutaneous tissue disorders - Other  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Vascular disorders       
Flushing  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Hematoma  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Hypertension  1  2/89 (2.25%)  0/91 (0.00%)  2/91 (2.20%) 
Hypotension  1  3/89 (3.37%)  0/91 (0.00%)  3/91 (3.30%) 
Thromboembolic event  1  1/89 (1.12%)  0/91 (0.00%)  1/91 (1.10%) 
Vascular disorders-Other  1  0/89 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Azacitidine/Lenalidomide Arm 2: Azacitidine Arm 3: Azacitidine/Vorinostat
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   88/89 (98.88%)   89/91 (97.80%)   91/91 (100.00%) 
Blood and lymphatic system disorders       
Anemia  1  76/89 (85.39%)  71/91 (78.02%)  72/91 (79.12%) 
Febrile neutropenia  1  13/89 (14.61%)  14/91 (15.38%)  13/91 (14.29%) 
Cardiac disorders       
Chest pain - cardiac  1  3/89 (3.37%)  2/91 (2.20%)  6/91 (6.59%) 
Sinus tachycardia  1  3/89 (3.37%)  4/91 (4.40%)  9/91 (9.89%) 
Gastrointestinal disorders       
Abdominal pain  1  8/89 (8.99%)  14/91 (15.38%)  21/91 (23.08%) 
Constipation  1  49/89 (55.06%)  54/91 (59.34%)  44/91 (48.35%) 
Diarrhea  1  42/89 (47.19%)  23/91 (25.27%)  53/91 (58.24%) 
Dry mouth  1  10/89 (11.24%)  9/91 (9.89%)  7/91 (7.69%) 
Dyspepsia  1  4/89 (4.49%)  13/91 (14.29%)  7/91 (7.69%) 
Gastroesophageal reflux disease  1  4/89 (4.49%)  1/91 (1.10%)  6/91 (6.59%) 
Hemorrhoids  1  5/89 (5.62%)  2/91 (2.20%)  4/91 (4.40%) 
Mucositis oral  1  15/89 (16.85%)  7/91 (7.69%)  10/91 (10.99%) 
Nausea  1  38/89 (42.70%)  42/91 (46.15%)  61/91 (67.03%) 
Oral pain  1  5/89 (5.62%)  2/91 (2.20%)  4/91 (4.40%) 
Vomiting  1  18/89 (20.22%)  18/91 (19.78%)  36/91 (39.56%) 
General disorders       
Chills  1  19/89 (21.35%)  11/91 (12.09%)  10/91 (10.99%) 
Edema limbs  1  24/89 (26.97%)  22/91 (24.18%)  28/91 (30.77%) 
Fatigue  1  74/89 (83.15%)  69/91 (75.82%)  74/91 (81.32%) 
Fever  1  14/89 (15.73%)  19/91 (20.88%)  15/91 (16.48%) 
General disorders and admin site conditions - Other  1  5/89 (5.62%)  4/91 (4.40%)  5/91 (5.49%) 
Injection site reaction  1  22/89 (24.72%)  19/91 (20.88%)  18/91 (19.78%) 
Non-cardiac chest pain  1  2/89 (2.25%)  3/91 (3.30%)  5/91 (5.49%) 
Pain  1  14/89 (15.73%)  10/91 (10.99%)  10/91 (10.99%) 
Infections and infestations       
Infections and infestations-Other  1  9/89 (10.11%)  10/91 (10.99%)  8/91 (8.79%) 
Lung infection  1  2/89 (2.25%)  6/91 (6.59%)  5/91 (5.49%) 
Skin infection  1  9/89 (10.11%)  13/91 (14.29%)  9/91 (9.89%) 
Upper respiratory infection  1  5/89 (5.62%)  6/91 (6.59%)  4/91 (4.40%) 
Urinary tract infection  1  8/89 (8.99%)  2/91 (2.20%)  3/91 (3.30%) 
Injury, poisoning and procedural complications       
Bruising  1  25/89 (28.09%)  24/91 (26.37%)  18/91 (19.78%) 
Fall  1  0/89 (0.00%)  6/91 (6.59%)  7/91 (7.69%) 
Injury, poison and procedural complications - Other  1  2/89 (2.25%)  5/91 (5.49%)  0/91 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  18/89 (20.22%)  16/91 (17.58%)  17/91 (18.68%) 
Alkaline phosphatase increased  1  17/89 (19.10%)  16/91 (17.58%)  13/91 (14.29%) 
Aspartate aminotransferase increased  1  18/89 (20.22%)  23/91 (25.27%)  17/91 (18.68%) 
Blood bilirubin increased  1  14/89 (15.73%)  13/91 (14.29%)  24/91 (26.37%) 
Creatinine increased  1  21/89 (23.60%)  26/91 (28.57%)  25/91 (27.47%) 
INR increased  1  4/89 (4.49%)  5/91 (5.49%)  3/91 (3.30%) 
Lymphocyte count decreased  1  32/89 (35.96%)  16/91 (17.58%)  19/91 (20.88%) 
Neutrophil count decreased  1  77/89 (86.52%)  58/91 (63.74%)  73/91 (80.22%) 
Platelet count decreased  1  78/89 (87.64%)  68/91 (74.73%)  69/91 (75.82%) 
Weight loss  1  22/89 (24.72%)  15/91 (16.48%)  19/91 (20.88%) 
White blood cell decreased  1  66/89 (74.16%)  52/91 (57.14%)  60/91 (65.93%) 
Metabolism and nutrition disorders       
Anorexia  1  39/89 (43.82%)  31/91 (34.07%)  45/91 (49.45%) 
Dehydration  1  9/89 (10.11%)  10/91 (10.99%)  17/91 (18.68%) 
Hypercalcemia  1  2/89 (2.25%)  6/91 (6.59%)  3/91 (3.30%) 
Hyperglycemia  1  33/89 (37.08%)  27/91 (29.67%)  32/91 (35.16%) 
Hyperkalemia  1  6/89 (6.74%)  6/91 (6.59%)  6/91 (6.59%) 
Hypermagnesemia  1  3/89 (3.37%)  7/91 (7.69%)  5/91 (5.49%) 
Hypernatremia  1  5/89 (5.62%)  3/91 (3.30%)  3/91 (3.30%) 
Hyperuricemia  1  2/89 (2.25%)  5/91 (5.49%)  3/91 (3.30%) 
Hypoalbuminemia  1  29/89 (32.58%)  21/91 (23.08%)  32/91 (35.16%) 
Hypocalcemia  1  30/89 (33.71%)  16/91 (17.58%)  25/91 (27.47%) 
Hypokalemia  1  40/89 (44.94%)  15/91 (16.48%)  19/91 (20.88%) 
Hypomagnesemia  1  13/89 (14.61%)  10/91 (10.99%)  9/91 (9.89%) 
Hyponatremia  1  23/89 (25.84%)  22/91 (24.18%)  34/91 (37.36%) 
Hypophosphatemia  1  4/89 (4.49%)  2/91 (2.20%)  6/91 (6.59%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  15/89 (16.85%)  11/91 (12.09%)  7/91 (7.69%) 
Back pain  1  16/89 (17.98%)  18/91 (19.78%)  14/91 (15.38%) 
Bone pain  1  6/89 (6.74%)  2/91 (2.20%)  3/91 (3.30%) 
Generalized muscle weakness  1  22/89 (24.72%)  15/91 (16.48%)  23/91 (25.27%) 
Musculoskeletal and connective tiss disorder - Other  1  5/89 (5.62%)  3/91 (3.30%)  1/91 (1.10%) 
Myalgia  1  16/89 (17.98%)  12/91 (13.19%)  6/91 (6.59%) 
Neck pain  1  6/89 (6.74%)  4/91 (4.40%)  1/91 (1.10%) 
Pain in extremity  1  19/89 (21.35%)  16/91 (17.58%)  12/91 (13.19%) 
Nervous system disorders       
Dizziness  1  19/89 (21.35%)  22/91 (24.18%)  28/91 (30.77%) 
Dysgeusia  1  11/89 (12.36%)  11/91 (12.09%)  16/91 (17.58%) 
Headache  1  12/89 (13.48%)  14/91 (15.38%)  16/91 (17.58%) 
Paresthesia  1  5/89 (5.62%)  1/91 (1.10%)  1/91 (1.10%) 
Peripheral sensory neuropathy  1  9/89 (10.11%)  10/91 (10.99%)  8/91 (8.79%) 
Tremor  1  5/89 (5.62%)  3/91 (3.30%)  2/91 (2.20%) 
Psychiatric disorders       
Anxiety  1  15/89 (16.85%)  13/91 (14.29%)  6/91 (6.59%) 
Confusion  1  3/89 (3.37%)  5/91 (5.49%)  4/91 (4.40%) 
Depression  1  9/89 (10.11%)  9/91 (9.89%)  12/91 (13.19%) 
Insomnia  1  18/89 (20.22%)  15/91 (16.48%)  14/91 (15.38%) 
Renal and urinary disorders       
Chronic kidney disease  1  1/89 (1.12%)  3/91 (3.30%)  7/91 (7.69%) 
Proteinuria  1  4/89 (4.49%)  7/91 (7.69%)  1/91 (1.10%) 
Urinary frequency  1  5/89 (5.62%)  2/91 (2.20%)  2/91 (2.20%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  7/89 (7.87%)  5/91 (5.49%)  5/91 (5.49%) 
Cough  1  24/89 (26.97%)  26/91 (28.57%)  28/91 (30.77%) 
Dyspnea  1  41/89 (46.07%)  36/91 (39.56%)  36/91 (39.56%) 
Epistaxis  1  5/89 (5.62%)  13/91 (14.29%)  11/91 (12.09%) 
Nasal congestion  1  3/89 (3.37%)  4/91 (4.40%)  6/91 (6.59%) 
Pleural effusion  1  1/89 (1.12%)  5/91 (5.49%)  4/91 (4.40%) 
Postnasal drip  1  7/89 (7.87%)  1/91 (1.10%)  1/91 (1.10%) 
Sore throat  1  7/89 (7.87%)  2/91 (2.20%)  8/91 (8.79%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  4/89 (4.49%)  3/91 (3.30%)  11/91 (12.09%) 
Dry skin  1  7/89 (7.87%)  4/91 (4.40%)  5/91 (5.49%) 
Hyperhidrosis  1  4/89 (4.49%)  4/91 (4.40%)  7/91 (7.69%) 
Pruritus  1  29/89 (32.58%)  15/91 (16.48%)  7/91 (7.69%) 
Purpura  1  6/89 (6.74%)  5/91 (5.49%)  7/91 (7.69%) 
Rash maculo-papular  1  46/89 (51.69%)  20/91 (21.98%)  16/91 (17.58%) 
Skin and subcutaneous tissue disorders - Other  1  14/89 (15.73%)  15/91 (16.48%)  5/91 (5.49%) 
Skin ulceration  1  4/89 (4.49%)  1/91 (1.10%)  6/91 (6.59%) 
Vascular disorders       
Hematoma  1  5/89 (5.62%)  4/91 (4.40%)  5/91 (5.49%) 
Hot flashes  1  9/89 (10.11%)  4/91 (4.40%)  5/91 (5.49%) 
Hypertension  1  10/89 (11.24%)  11/91 (12.09%)  11/91 (12.09%) 
Hypotension  1  13/89 (14.61%)  5/91 (5.49%)  15/91 (16.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Leukemia Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-6597
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01522976     History of Changes
Other Study ID Numbers: NCI-2012-00242
NCI-2012-00242 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S1117
CDR0000723909
S1117 ( Other Identifier: SWOG )
S1117 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2012
First Posted: February 1, 2012
Results First Submitted: February 18, 2016
Results First Posted: March 22, 2016
Last Update Posted: December 5, 2018