Trial Outcomes & Findings for High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML (NCT NCT02768792)
NCT ID: NCT02768792
Last Updated: 2024-09-25
Results Overview
The rate of overall CR includes CR and CR with incomplete recovery (CRi) as defined by the International European LeukemiaNet Guidelines in AML. CR is defined as bone marrow blasts \<5%; absence of Auer rods; absence of extramedullary disease; absolute neutrophil count \>1,000/microliter (mcL); platelet count \>100,000/mcL; independence of red cell transfusions and CRi is defined as meeting all CR criteria except for residual neutropenia (\<1,000/mcL) or thrombocytopenia (\<100,000/mcL) plus independent of platelet transfusions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Day 14 until 2 years complete on study treatment and after full hematologic recovery from HiDAC followed by pembrolizumab
Results posted on
2024-09-25
Participant Flow
Subjects were recruited from two cancer centers between August 2016 and April 2019.
A total of 62 subjects were consented to screen for eligibility. Of these, 19 were determined to be ineligible and 5 withdrew consent prior to starting the study.
Participant milestones
| Measure |
Single Arm Pembrolizumab
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single Arm Pembrolizumab
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML
Baseline characteristics by cohort
| Measure |
Single Arm Pembrolizumab
n=37 Participants
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
|
Acute myeloid leukemia (AML) type
Refractory AML
|
16 Participants
n=5 Participants
|
|
Acute myeloid leukemia (AML) type
Relapsed AML
|
21 Participants
n=5 Participants
|
|
Risk
Favorable
|
6 Participants
n=5 Participants
|
|
Risk
Intermediate
|
12 Participants
n=5 Participants
|
|
Risk
Adverse
|
19 Participants
n=5 Participants
|
|
Secondary Acute Myeloid Leukemia (AML)
|
13 Participants
n=5 Participants
|
|
Median Bone Marrow Blast Percentage
|
28 percentage of blast cells
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14 until 2 years complete on study treatment and after full hematologic recovery from HiDAC followed by pembrolizumabThe rate of overall CR includes CR and CR with incomplete recovery (CRi) as defined by the International European LeukemiaNet Guidelines in AML. CR is defined as bone marrow blasts \<5%; absence of Auer rods; absence of extramedullary disease; absolute neutrophil count \>1,000/microliter (mcL); platelet count \>100,000/mcL; independence of red cell transfusions and CRi is defined as meeting all CR criteria except for residual neutropenia (\<1,000/mcL) or thrombocytopenia (\<100,000/mcL) plus independent of platelet transfusions.
Outcome measures
| Measure |
Single Arm Pembrolizumab
n=37 Participants
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
The Rate of Complete Remission (CR)
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 14 until 2 years complete on study treatmentnumber of participants with drug-related grade 3 (severe) non-hematologic toxicity (with exception of infusion reactions, rash, fever, infection, nausea, fatigue, and anorexia) persisting for \>7 days with supportive care, or any drug-related non-hematologic grade \>4 (life-threatening) toxicity (excluding infection). Toxicity will be classified and graded according to National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term ranging from 1 (mild) to 5 (death related to adverse event).
Outcome measures
| Measure |
Single Arm Pembrolizumab
n=37 Participants
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Rate of Unacceptable Toxicity
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14 until 2 years complete on study treatmentPR+CR+CRi as determined by International European LeukemiaNet Guidelines in AML. PR is defined as bone marrow blasts 5-25% and decrease of pretreatment bone marrow blast % by \>50%; all hematologic criteria of CR. CR is defined as bone marrow blasts \<5%; absence of Auer rods; absence of extramedullary disease; absolute neutrophil count \>1,000/microliter (mcL); platelet count \>100,000/mcL; independence of red cell transfusions and CRi is defined as meeting all CR criteria except for residual neutropenia (\<1,000/mcL) or thrombocytopenia (\<100,000/mcL) plus independent of platelet transfusions.
Outcome measures
| Measure |
Single Arm Pembrolizumab
n=37 Participants
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Objective Overall Response Rate: Partial Remission (PR) + Complete Remission (CR) + Complete Remission With Incomplete Blood Count Recovery (CRi) for HiDAC Followed by Pembrolizumab
|
16 Participants
|
SECONDARY outcome
Timeframe: from Day 1 of complete remission up to 7 years of follow-up (a median of 7.8 months of survivor follow-up at time of reporting)RFS will be defined as time from day 1 of Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi) to relapse or death from any cause. CR is defined as bone marrow blasts \<5%; absence of Auer rods; absence of extramedullary disease; absolute neutrophil count \>1,000/microliter (mcL); platelet count \>100,000/mcL; independence of red cell transfusions and CRi is defined as meeting all CR criteria except for residual neutropenia (\<1,000/mcL) or thrombocytopenia (\<100,000/mcL) plus independent of platelet transfusions.
Outcome measures
| Measure |
Single Arm Pembrolizumab
n=37 Participants
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Median Relapse-free Survival (RFS) of Patients Receiving Maintenance Pembrolizumab
|
6.9 Months
Interval 4.2 to 11.5
|
SECONDARY outcome
Timeframe: from Day 1 of response up to 7 years of follow-up (a median of 7.8 months of survivor follow-up at time of reporting)PFS will be defined as time from day 1 of response (i.e., PR/CR/CRi) to progression or death from any cause. PR+CR+CRi s determined by International European LeukemiaNet Guidelines in AML. PR is defined as bone marrow blasts 5-25% and decrease of pretreatment bone marrow blast % by \>50%; all hematologic criteria of CR. CR is defined as bone marrow blasts \<5%; absence of Auer rods; absence of extramedullary disease; absolute neutrophil count \>1,000/microliter (mcL); platelet count \>100,000/mcL; independence of red cell transfusions and CRi is defined as meeting all CR criteria except for residual neutropenia (\<1,000/mcL) or thrombocytopenia (\<100,000/mcL) plus independent of platelet transfusions.
Outcome measures
| Measure |
Single Arm Pembrolizumab
n=37 Participants
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Median Progression-free Survival (PFS) of Patients Receiving Maintenance Pembrolizumab.
|
5.7 Months
Interval 1.9 to 7.3
|
SECONDARY outcome
Timeframe: from Day 1 of treatment up to 7 years of follow-up (with a median of 7.8 months of follow-up at time of reporting)OS is defined as time from day 1 of treatment until date of last known follow up or death of any cause
Outcome measures
| Measure |
Single Arm Pembrolizumab
n=37 Participants
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Median Overall Survival (OS) of Patients Who Received Induction Phase of Treatment.
|
8.9 Months
Interval 6.0 to 13.1
|
Adverse Events
Single Arm Pembrolizumab
Serious events: 14 serious events
Other events: 37 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Single Arm Pembrolizumab
n=37 participants at risk
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Arachnoiditis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify -E.Coli infection in blood
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Blood bilirubin increased
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Catheter related infection
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Fever
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Lung infection
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Meningitis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Transient ischemic attacks
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
Other adverse events
| Measure |
Single Arm Pembrolizumab
n=37 participants at risk
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
21.6%
8/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Activated partial thromboplastin time prolonged
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Alanine aminotransferase increased
|
59.5%
22/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Alkaline phosphatase increased
|
56.8%
21/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Blood and lymphatic system disorders
Anemia
|
86.5%
32/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
29.7%
11/37 • Day 14 until 2 years complete on study treatment
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.2%
6/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Ascites
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
62.2%
23/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Ataxia
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.9%
7/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Blood bilirubin increased
|
48.6%
18/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Blurred vision
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.2%
6/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Cardiac troponin I increased
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Catheter related infection
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Chills
|
16.2%
6/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Conjunctivitis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Constipation
|
37.8%
14/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.7%
11/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Creatinine increased
|
24.3%
9/37 • Day 14 until 2 years complete on study treatment
|
|
Immune system disorders
Cytokine release syndrome
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
43.2%
16/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Dizziness
|
21.6%
8/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Dry eye
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Dysarthria
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Dysgeusia
|
18.9%
7/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.6%
8/37 • Day 14 until 2 years complete on study treatment
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Edema limbs
|
16.2%
6/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Edema trunk
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Ejection fraction decreased
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Enterocolitis infectious
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.3%
9/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Esophagitis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Eye pain
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Facial pain
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Fatigue
|
59.5%
22/37 • Day 14 until 2 years complete on study treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
64.9%
24/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Fever
|
59.5%
22/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Floaters
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Genital edema
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Haptoglobin decreased
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Headache
|
56.8%
21/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Heart failure
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Renal and urinary disorders
Hematuria
|
27.0%
10/37 • Day 14 until 2 years complete on study treatment
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Hepatic infection
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.9%
7/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
27.0%
10/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Vascular disorders
Hypertension
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Endocrine disorders
Hyperthyroidism
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
83.8%
31/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
78.4%
29/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
78.4%
29/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
51.4%
19/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
48.6%
18/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
21.6%
8/37 • Day 14 until 2 years complete on study treatment
|
|
Vascular disorders
Hypotension
|
24.3%
9/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Hypothermia
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Endocrine disorders
Hypothyroidism
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
INR increased
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Immune system disorders
Immune system disorders - Other, specify
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Infusion related reaction
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Psychiatric disorders
Insomnia
|
16.2%
6/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Investigations - Other, specify
|
21.6%
8/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Lipase increased
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Lung infection
|
27.0%
10/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Lymphocyte count decreased
|
81.1%
30/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Lymphocyte count increased
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Memory impairment
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Mitral valve disease
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Mucosal infection
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.2%
6/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Nausea
|
64.9%
24/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Neutrophil count decreased
|
78.4%
29/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Non-cardiac chest pain
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Nystagmus
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Obesity
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Oral pain
|
18.9%
7/37 • Day 14 until 2 years complete on study treatment
|
|
General disorders
Pain
|
21.6%
8/37 • Day 14 until 2 years complete on study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.9%
7/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Palpitations
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Paresthesia
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Pericardial effusion
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Photophobia
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Platelet count decreased
|
91.9%
34/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Prostatic pain
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Renal and urinary disorders
Proteinuria
|
18.9%
7/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
43.2%
16/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
13.5%
5/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
48.6%
18/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Rectal pain
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Scrotal pain
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Sinus bradycardia
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Sinus pain
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Sinus tachycardia
|
21.6%
8/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.8%
4/37 • Day 14 until 2 years complete on study treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Somnolence
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Syncope
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Toothache
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Nervous system disorders
Tremor
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Tricuspid valve disease
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Typhlitis
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Upper respiratory infection
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Urinary tract infection
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Reproductive system and breast disorders
Uterine pain
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Infections and infestations
Vaginal infection
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
8.1%
3/37 • Day 14 until 2 years complete on study treatment
|
|
Gastrointestinal disorders
Vomiting
|
29.7%
11/37 • Day 14 until 2 years complete on study treatment
|
|
Eye disorders
Watering eyes
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Weight gain
|
5.4%
2/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
Weight loss
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.7%
1/37 • Day 14 until 2 years complete on study treatment
|
|
Investigations
White blood cell decreased
|
91.9%
34/37 • Day 14 until 2 years complete on study treatment
|
Additional Information
Robin V. Johnson
University of North Carolina Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place