Trial Outcomes & Findings for Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia (NCT NCT04277442)
NCT ID: NCT04277442
Last Updated: 2025-03-25
Results Overview
Toxicity will be graded and reported according to the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
1 participants
Primary outcome timeframe
Up to day 15 of cycle 1 (each cycle is 28 days)
Results posted on
2025-03-25
Participant Flow
Participant milestones
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 Participants
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
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
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
PRIMARY outcome
Timeframe: Up to day 15 of cycle 1 (each cycle is 28 days)Toxicity will be graded and reported according to the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 Participants
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Incidence of Adverse Events
Diarrhea
|
1 participants
|
|
Incidence of Adverse Events
Mucositis oral
|
1 participants
|
|
Incidence of Adverse Events
Dyspnea
|
1 participants
|
|
Incidence of Adverse Events
Cough
|
1 participants
|
|
Incidence of Adverse Events
Electrocardiogram QT corrected interval prolonged
|
1 participants
|
|
Incidence of Adverse Events
Hematuria
|
1 participants
|
|
Incidence of Adverse Events
Proteinuria
|
1 participants
|
|
Incidence of Adverse Events
Hyponatremia
|
1 participants
|
|
Incidence of Adverse Events
Blood bilirubin increased
|
1 participants
|
|
Incidence of Adverse Events
Alkaline phosphatase increased
|
1 participants
|
|
Incidence of Adverse Events
Alanine aminotransferase increased
|
1 participants
|
|
Incidence of Adverse Events
Aspartate aminotransferase increased
|
1 participants
|
|
Incidence of Adverse Events
Blood lactate dehydrogenase increased
|
1 participants
|
|
Incidence of Adverse Events
INR increased
|
1 participants
|
|
Incidence of Adverse Events
Anemia
|
1 participants
|
|
Incidence of Adverse Events
Urinary tract infection
|
1 participants
|
|
Incidence of Adverse Events
Febrile neutropenia
|
1 participants
|
|
Incidence of Adverse Events
Confusion
|
1 participants
|
|
Incidence of Adverse Events
Bacteremia
|
1 participants
|
|
Incidence of Adverse Events
Epistaxis
|
1 participants
|
|
Incidence of Adverse Events
Nausea
|
1 participants
|
|
Incidence of Adverse Events
Vomiting
|
1 participants
|
|
Incidence of Adverse Events
Hypophosphatemia
|
1 participants
|
|
Incidence of Adverse Events
Hypoalbuminemia
|
1 participants
|
|
Incidence of Adverse Events
Activate partial thromboplastin time prolonged
|
1 participants
|
|
Incidence of Adverse Events
White blood cell decreased
|
1 participants
|
|
Incidence of Adverse Events
Platelet count decreased
|
1 participants
|
|
Incidence of Adverse Events
Neutrophil count decreased
|
1 participants
|
|
Incidence of Adverse Events
Lymphocyte count decreased
|
1 participants
|
|
Incidence of Adverse Events
Hypocalcemia
|
1 participants
|
|
Incidence of Adverse Events
Thromboembolic event
|
1 participants
|
|
Incidence of Adverse Events
Lung infection
|
1 participants
|
|
Incidence of Adverse Events
Hypothermia
|
1 participants
|
|
Incidence of Adverse Events
Thrush
|
1 participants
|
|
Incidence of Adverse Events
Anorexia
|
1 participants
|
|
Incidence of Adverse Events
Neutropenic Fever
|
1 participants
|
|
Incidence of Adverse Events
Fatigue
|
1 participants
|
|
Incidence of Adverse Events
Edema face
|
1 participants
|
|
Incidence of Adverse Events
Chills
|
1 participants
|
PRIMARY outcome
Timeframe: Up to day 15 of cycle 1 (each cycle is 28 days)Feasibility will be met if 10 of 13 patients are able to complete 3 cycles of therapy.
Outcome measures
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 Participants
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Number of Patients That Are Able to Complete 3 Cycles of Therapy
|
0 participants
|
PRIMARY outcome
Timeframe: Up to day 15 of cycle 1 (each cycle is 28 days)Response will be defined as being able to achieve complete remission, complete remission with incomplete count recovery, or complete remission with incomplete hematological recovery by cycle 3.
Outcome measures
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 Participants
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Response
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data was not collected due to low enrollment
Patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Data that are collected serially over time will be explored graphically using box plots and/or individual time plots as well as analytically with either repeated measures analysis of variance or Friedman's nonparametric test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years 5 months95% confidence intervals will be given.
Outcome measures
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 Participants
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Progression-free Survival
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 years 5 months95% confidence intervals will be given.
Outcome measures
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 Participants
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Overall Survival
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data not collected due to low enrollment
Will assess MRD by measuring the TP53 mutational burden with variant allele frequency before and after response is achieved to see if there is a change. Will also evaluate its association with MRD status at each time point using chi-square test of independence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data not collected and analyzed due to low enrollment
Will study the T cell response against both tumor associated antigen and tumor specific antigen. Analyses of the data will be primarily descriptive in nature given the relatively small sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data not collected or analyzed due to low enrollment
Will study the level of global DNA methylation as well as methylation levels of specific genes involved in immune checkpoint, such as PD-L1, PD-L2, PD-1 and CTLA4. Analyses of the data will be primarily descriptive in nature given the relatively small sample size.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Nivolumab, Decitabine, Venetoclax)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 participants at risk
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
Other adverse events
| Measure |
Treatment (Nivolumab, Decitabine, Venetoclax)
n=1 participants at risk
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Nivolumab: Given IV
Venetoclax: Given PO
|
|---|---|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
General disorders
Edema Face
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Gastrointestinal disorders
Mucositis Oral
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Electrocardiogram QT corrected Interval prolonged
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Renal and urinary disorders
Hematuria
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Renal and urinary disorders
Proteinuria
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Blood bilirubin Increased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Alkaline Phosphatase Increased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Blood lactate dehydrogena se Increased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
NR Increased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Psychiatric disorders
Confusion
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Infections and infestations
Bacteremia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Vascular disorders
Thromboembolic
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
General disorders
Chills
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Infections and infestations
Lung Infection
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
General disorders
Hypothermia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Infections and infestations
Thrush
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • Patients were evaluated for Adverse Events from the start of study to study completion using the NCI CTCAE version 5.0 for up to 2 years 5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60