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Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02996474
Recruitment Status : Completed
First Posted : December 19, 2016
Results First Posted : May 21, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed Acute Myeloid Leukemia
Interventions Drug: Pembrolizumab
Drug: Decitabine
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pembrolizumab and Decitabine for Treatment of AML
Hide Arm/Group Description Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
Period Title: Overall Study
Started 10
Completed 5
Not Completed 5
Reason Not Completed
Physician Decision             5
Arm/Group Title Pembrolizumab and Decitabine for Treatment of AML
Hide Arm/Group Description Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  60.0%
>=65 years
4
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  30.0%
White
6
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Feasibility of a Novel Combination of Pembrolizumab and Decitabine in Relapsed/Refractory AML Patients
Hide Description The number of patients who could be treated without being removed from the protocol due to treatment related toxicities.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled on study.
Arm/Group Title Pembrolizumab and Decitabine for Treatment of AML
Hide Arm/Group Description:
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
10
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pembrolizumab and Decitabine for Treatment of AML
Hide Arm/Group Description Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
All-Cause Mortality
Pembrolizumab and Decitabine for Treatment of AML
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Serious Adverse Events
Pembrolizumab and Decitabine for Treatment of AML
Affected / at Risk (%)
Total   7/10 (70.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  6/10 (60.00%) 
Gastrointestinal disorders   
Diarrhoea  1  1/10 (10.00%) 
General disorders   
Pain  1  2/10 (20.00%) 
Infections and infestations   
Sepsis  1  2/10 (20.00%) 
Wound infection bacterial  1  1/10 (10.00%) 
Investigations   
Blood culture positive  1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  2/10 (20.00%) 
Hypophosphataemia  1  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/10 (10.00%) 
Nervous system disorders   
Headache  1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/10 (10.00%) 
Vascular disorders   
Hypotension  1  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pembrolizumab and Decitabine for Treatment of AML
Affected / at Risk (%)
Total   10/10 (100.00%) 
Blood and lymphatic system disorders   
Increased tendency to bruise  1  3/10 (30.00%) 
Petechiae  1  4/10 (40.00%) 
Cardiac disorders   
Atrial flutter  1  1/10 (10.00%) 
Cardiomegaly  1  2/10 (20.00%) 
Dizziness  1  2/10 (20.00%) 
Dyspnoea  1  5/10 (50.00%) 
Localised oedema  1  4/10 (40.00%) 
Oedema peripheral  1  2/10 (20.00%) 
Palpitations  1  1/10 (10.00%) 
Pericardial effusion  1  3/10 (30.00%) 
Sinus bradycardia  1  1/10 (10.00%) 
Sinus tachycardia  1  1/10 (10.00%) 
Endocrine disorders   
Diabetes insipidus  1  1/10 (10.00%) 
Hyperglycaemia  1  5/10 (50.00%) 
Hypoglycaemia  1  2/10 (20.00%) 
Hypothyroidism  1  2/10 (20.00%) 
Thyroid mass  1  1/10 (10.00%) 
Eye disorders   
Conjunctival haemorrhage  1  1/10 (10.00%) 
Conjunctivitis  1  1/10 (10.00%) 
Dry eye  1  1/10 (10.00%) 
Eye pain  1  2/10 (20.00%) 
Eye symptom  1  1/10 (10.00%) 
Myopia  1  1/10 (10.00%) 
Nystagmus  1  1/10 (10.00%) 
Vision blurred  1  1/10 (10.00%) 
Gastrointestinal disorders   
Abdominal distension  1  3/10 (30.00%) 
Abdominal pain  1  2/10 (20.00%) 
Anorectal discomfort  1  1/10 (10.00%) 
Constipation  1  6/10 (60.00%) 
Diarrhoea  1  1/10 (10.00%) 
Dry mouth  1  1/10 (10.00%) 
Dyspepsia  1  3/10 (30.00%) 
Dysphagia  1  2/10 (20.00%) 
Fecal incontinence  1  1/10 (10.00%) 
Gingival bleeding  1  2/10 (20.00%) 
Haemorrhoids  1  1/10 (10.00%) 
Lip ulceration  1  1/10 (10.00%) 
Nausea  1  4/10 (40.00%) 
Oral hemorrhage  1  1/10 (10.00%) 
Oral mucosal blistering  1  1/10 (10.00%) 
Oral pain  1  4/10 (40.00%) 
Perirectal abscess  1  1/10 (10.00%) 
Throat irritation  1  1/10 (10.00%) 
Vomiting  1  2/10 (20.00%) 
General disorders   
Chills  1  2/10 (20.00%) 
Decreased appetite  1  4/10 (40.00%) 
Fatigue  1  8/10 (80.00%) 
Gait disturbance  1  1/10 (10.00%) 
Generalised oedema  1  1/10 (10.00%) 
Head discomfort  1  1/10 (10.00%) 
Hematoma  1  1/10 (10.00%) 
Lethargy  1  4/10 (40.00%) 
Malaise  1  4/10 (40.00%) 
Non-cardiac chest pain  1  3/10 (30.00%) 
Pain  1  4/10 (40.00%) 
Pain in extremity  1  1/10 (10.00%) 
Vascular access complication  1  1/10 (10.00%) 
Vessel puncture site bruise  1  1/10 (10.00%) 
Hepatobiliary disorders   
Hepatomegaly  1  1/10 (10.00%) 
Hypoalbuminaemia  1  5/10 (50.00%) 
Infections and infestations   
Enterococcal infection  1  1/10 (10.00%) 
Infections and infestations- Other, specify- Bacteremia  1  1/10 (10.00%) 
Paronychia  1  2/10 (20.00%) 
Upper respiratory tract infection  1  1/10 (10.00%) 
Wound infection  1  1/10 (10.00%) 
Injury, poisoning and procedural complications   
Blister  1  2/10 (20.00%) 
Fall  1  2/10 (20.00%) 
Fracture  1  2/10 (20.00%) 
Post-operative hemorrhage  1  1/10 (10.00%) 
Skin wound  1  1/10 (10.00%) 
Tendonitis  1  1/10 (10.00%) 
Investigations   
Activated partial thromboplastin time prolonged  1  6/10 (60.00%) 
Alanine aminotransferase increased  1  7/10 (70.00%) 
Alkaline phosphatase increased  1  1/10 (10.00%) 
Aspartate aminotransferase increased  1  5/10 (50.00%) 
Blood alkaline phosphatase increased  1  2/10 (20.00%) 
Blood bilirubin increased  1  2/10 (20.00%) 
Blood creatinine increased  1  1/10 (10.00%) 
Blood thyroid stimulating hormone increased  1  2/10 (20.00%) 
Blood urine present  1  2/10 (20.00%) 
Body temperature increased  1  5/10 (50.00%) 
Electrocardiogram QT corrected interval prolonged  1  1/10 (10.00%) 
Electrocardiogram QT prolonged  1  1/10 (10.00%) 
Heart rate irregular  1  1/10 (10.00%) 
Hypoalbuminemia  1  1/10 (10.00%) 
Hyponatremia  1  1/10 (10.00%) 
Imaging procedure abnormal  1  4/10 (40.00%) 
Influenza like illness  1  1/10 (10.00%) 
Lymphocyte count decreased  1  3/10 (30.00%) 
Neutrophil count decreased  1  3/10 (30.00%) 
Platelet count decreased  1  9/10 (90.00%) 
Surgical and medical procedures - Other, specify- Skin biopsy  1  1/10 (10.00%) 
Weight decreased  1  1/10 (10.00%) 
Weight gain  1  1/10 (10.00%) 
Weight increased  1  5/10 (50.00%) 
Weight loss  1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Anorexia nervosa  1  1/10 (10.00%) 
Hypernatraemia  1  3/10 (30.00%) 
Hyperuricaemia  1  1/10 (10.00%) 
Hypocalcaemia  1  4/10 (40.00%) 
Hypokalaemia  1  4/10 (40.00%) 
Hypomagnesaemia  1  2/10 (20.00%) 
Hyponatraemia  1  3/10 (30.00%) 
Hypophosphataemia  1  3/10 (30.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/10 (10.00%) 
Myalgia  1  1/10 (10.00%) 
Neck pain  1  3/10 (30.00%) 
Pain in extremity  1  1/10 (10.00%) 
Tenosynovitis  1  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bartholin's cyst  1  1/10 (10.00%) 
Haemangioma  1  1/10 (10.00%) 
Renal cyst  1  1/10 (10.00%) 
Nervous system disorders   
Altered state of consciousness  1  1/10 (10.00%) 
Confusional state  1  1/10 (10.00%) 
Headache  1  4/10 (40.00%) 
Insomnia  1  2/10 (20.00%) 
Somnolence  1  1/10 (10.00%) 
Urinary incontinence  1  1/10 (10.00%) 
Psychiatric disorders   
Anxiety  1  3/10 (30.00%) 
Renal and urinary disorders   
Acute kidney injury  1  1/10 (10.00%) 
Micturition urgency  1  1/10 (10.00%) 
Polyuria  1  1/10 (10.00%) 
Proteinuria  1  2/10 (20.00%) 
Reproductive system and breast disorders   
Oedema genital  1  1/10 (10.00%) 
Vulvovaginal pain  1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  3/10 (30.00%) 
Bronchial wall thickening  1  1/10 (10.00%) 
Cough  1  2/10 (20.00%) 
Dyspnea  1  1/10 (10.00%) 
Epistaxis  1  2/10 (20.00%) 
Lung infiltration  1  2/10 (20.00%) 
Nasal congestion  1  2/10 (20.00%) 
Pleural effusion  1  3/10 (30.00%) 
Productive cough  1  1/10 (10.00%) 
Pulmonary edema  1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders- Bronchiectasis  1  1/10 (10.00%) 
Wheezing  1  2/10 (20.00%) 
Skin and subcutaneous tissue disorders   
Acne  1  1/10 (10.00%) 
Dry skin  1  3/10 (30.00%) 
Photosensitivity reaction  1  1/10 (10.00%) 
Pruritus  1  3/10 (30.00%) 
Skin hyperpigmentation  1  1/10 (10.00%) 
Surgical and medical procedures   
Mucositis management  1  1/10 (10.00%) 
Vascular disorders   
Embolism  1  1/10 (10.00%) 
Extremity necrosis  1  1/10 (10.00%) 
Hypertension  1  1/10 (10.00%) 
Hypotension  1  7/10 (70.00%) 
Intracranial hemorrhage  1  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
The 5 patients who did not complete the study were for reason other than treatment related toxicities.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Hourigan
Organization: National Heart Lung and Blood Institute
Phone: +1 301 451 0257
EMail: christopher.hourigan@nih.gov
Publications:
Katherine E Lindblad, Julie Thompson, Gege Gui, Janet Valdez, Tatyana Worthy, Hanna Tekleab, Tom Hughes, Meghali Goswami, Karolyn Oetjen, Dong-Yun Kim, Laura Dillon, Christin DeStefano, Catherine E. Lai, Christopher S. Hourigan; Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia. Blood 2018; 132 (Supplement 1): 1437.
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT02996474    
Other Study ID Numbers: 170026
17-H-0026
First Submitted: December 16, 2016
First Posted: December 19, 2016
Results First Submitted: May 4, 2020
Results First Posted: May 21, 2020
Last Update Posted: June 9, 2020