Trial Outcomes & Findings for Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL (NCT NCT02362997)
NCT ID: NCT02362997
Last Updated: 2026-02-12
Results Overview
Proportion of patients alive and disease-free 18 months from autologous stem cell transplantation (ASCT). Progression criteria are per Lugano 2014 criteria. All patients receiving any amount of protocol treatment. Patients who have progressed or lost to follow-up prior to 18 months are counted as failures; only patients followed and progression-free for at least 18 months are counted as successes.
COMPLETED
PHASE2
82 participants
18 Months
2026-02-12
Participant Flow
Participant milestones
| Measure |
Diffuse Large B Cell Lymphoma
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
21
|
|
Overall Study
COMPLETED
|
31
|
30
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL
Baseline characteristics by cohort
| Measure |
Diffuse Large B Cell Lymphoma
n=31 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
8 Participants
n=47 Participants
|
1 Participants
n=55 Participants
|
6 Participants
n=102 Participants
|
15 Participants
n=1267 Participants
|
|
Age, Continuous
|
57 years
n=47 Participants
|
34 years
n=55 Participants
|
58 years
n=102 Participants
|
50 years
n=1267 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=47 Participants
|
14 Participants
n=55 Participants
|
9 Participants
n=102 Participants
|
32 Participants
n=1267 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=47 Participants
|
16 Participants
n=55 Participants
|
12 Participants
n=102 Participants
|
50 Participants
n=1267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=47 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=1267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=47 Participants
|
18 Participants
n=55 Participants
|
13 Participants
n=102 Participants
|
55 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=47 Participants
|
1 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=47 Participants
|
12 Participants
n=55 Participants
|
8 Participants
n=102 Participants
|
24 Participants
n=1267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=47 Participants
|
12 Participants
n=55 Participants
|
8 Participants
n=102 Participants
|
26 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=47 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=47 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=47 Participants
|
0 Participants
n=55 Participants
|
2 Participants
n=102 Participants
|
3 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=47 Participants
|
17 Participants
n=55 Participants
|
10 Participants
n=102 Participants
|
52 Participants
n=1267 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=47 Participants
|
30 participants
n=55 Participants
|
21 participants
n=102 Participants
|
82 participants
n=1267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=47 Participants
|
29 Participants
n=55 Participants
|
15 Participants
n=102 Participants
|
67 Participants
n=1267 Participants
|
|
ECOG Performance Score
00- Fully Active
|
10 Participants
n=47 Participants
|
14 Participants
n=55 Participants
|
4 Participants
n=102 Participants
|
28 Participants
n=1267 Participants
|
|
ECOG Performance Score
01- Restricted
|
20 Participants
n=47 Participants
|
16 Participants
n=55 Participants
|
16 Participants
n=102 Participants
|
52 Participants
n=1267 Participants
|
|
ECOG Performance Score
02- Ambulatory and Capable of Self Care
|
1 Participants
n=47 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=1267 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=47 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=1267 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsProportion of patients alive and disease-free 18 months from autologous stem cell transplantation (ASCT). Progression criteria are per Lugano 2014 criteria. All patients receiving any amount of protocol treatment. Patients who have progressed or lost to follow-up prior to 18 months are counted as failures; only patients followed and progression-free for at least 18 months are counted as successes.
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=31 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Progression-free Survival After ASCT
|
0.58 proportion of participants
Interval 0.42 to 0.73
|
0.77 proportion of participants
Interval 0.61 to 0.89
|
0.62 proportion of participants
Interval 0.42 to 0.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 MonthsSurvival probability of patients alive 18 months from ASCT, time-to-event
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=31 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
0.93 survival probability
Interval 0.85 to 1.0
|
1.0 survival probability
Interval 1.0 to 1.0
|
0.94 survival probability
Interval 0.86 to 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: Patients who have been followed for at least 18 months or have relapsed prior to 18 months post ASCT
Number of patients who relapse within 18 months from autologous stem cell transplantation.
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=25 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=28 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=16 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Relapse
|
11 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsNumber of patients who experienced at least a grade 2 toxicity with "definite," "probable," or "possible" attribute to study treatment, according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=31 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability Assessed by CTCAE v4 Grade 2 and Above Toxicity Related to Study Treatment
|
21 Participants
|
15 Participants
|
12 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsIn patients with measurable disease after ASCT, rate of objective response after treatment. Response was assessed using the Lugano 2014 criteria.
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=31 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Response Rate to Pembrolizumab
|
0.74 proportion of participants
Interval 0.58 to 0.86
|
0.90 proportion of participants
Interval 0.76 to 0.97
|
0.86 proportion of participants
Interval 0.67 to 0.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsProgression-free survival probability of patients who are alive and without progression 18 months from ASCT, time-to-event
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=31 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
0.74 progression-free survival probability
Interval 0.62 to 0.9
|
0.87 progression-free survival probability
Interval 0.77 to 0.97
|
0.84 progression-free survival probability
Interval 0.7 to 0.99
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsSurvival probability of patients alive 18 months from ASCT stratified by PET status before transplantation, time-to-event. Patients categorized by complete metabolic response (complete response by PET scan, assessed using the Lugano 2014 criteria), partial response (assessed using Lugano 2014 criteria) prior to transplantation.
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=20 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=11 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=23 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
n=7 Participants
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
n=19 Participants
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
n=2 Participants
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Overall Survival After ASCT by PET Status
|
0.94 survival probability
Interval 0.85 to 1.0
|
0.91 survival probability
Interval 0.78 to 1.0
|
1.0 survival probability
Interval 1.0 to 1.0
|
1.0 survival probability
Interval 1.0 to 1.0
|
0.94 survival probability
Interval 0.84 to 1.0
|
1.0 survival probability
Interval 1.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsProgression-free survival probability of patients alive and disease-free 18 months from ASCT stratified by PET status before transplantation, time-to-event
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=20 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=11 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=23 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
n=7 Participants
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
n=19 Participants
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
n=2 Participants
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Progression-free Survival After ASCT by PET Status
|
0.87 progression-free survival probability
Interval 0.74 to 1.0
|
0.54 progression-free survival probability
Interval 0.35 to 0.86
|
0.82 progression-free survival probability
Interval 0.7 to 0.97
|
1.0 progression-free survival probability
Interval 1.0 to 1.0
|
0.82 progression-free survival probability
Interval 0.67 to 0.99
|
1.0 progression-free survival probability
Interval 1.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNumber of patients who complete the planned treatment
Outcome measures
| Measure |
Diffuse Large B Cell Lymphoma
n=31 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 Participants
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma - PET-NCR
Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation
|
Peripheral T Cell - PET-CR
Peripheral T Cell patients who were PET-CR before transplantation
|
Peripheral T Cell - PET-NCR
Peripheral T Cell patients who were not PET-CR before transplantation
|
|---|---|---|---|---|---|---|
|
Completion Rate
|
18 Participants
|
23 Participants
|
14 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsLevel of MRD detected by PCR (if feasible) before and after pembrolizumab
Outcome measures
Outcome data not reported
Adverse Events
Diffuse Large B Cell Lymphoma
Classical Hodgkin Lymphoma
Peripheral T Cell Lymphoma
Serious adverse events
| Measure |
Diffuse Large B Cell Lymphoma
n=31 participants at risk
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 participants at risk
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 participants at risk
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
|---|---|---|---|
|
Investigations
Neutrophil count decreased
|
19.4%
6/31 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
Platelet count decreased
|
6.5%
2/31 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
White blood cell decreased
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Nervous system disorders
Syncope
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
Other adverse events
| Measure |
Diffuse Large B Cell Lymphoma
n=31 participants at risk
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Classical Hodgkin Lymphoma
n=30 participants at risk
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
Peripheral T Cell Lymphoma
n=21 participants at risk
Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Pembrolizumab: Anti-PD-1 monoclonal antibody
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
32.3%
10/31 • Number of events 12 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
30.0%
9/30 • Number of events 23 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 10 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
Aspartate aminotransferase increased
|
32.3%
10/31 • Number of events 11 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
26.7%
8/30 • Number of events 13 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 8 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
White blood cell decreased
|
29.0%
9/31 • Number of events 19 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
30.0%
9/30 • Number of events 24 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
Neutrophil count decreased
|
48.4%
15/31 • Number of events 25 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
23.3%
7/30 • Number of events 9 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.7%
12/31 • Number of events 19 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
23.3%
7/30 • Number of events 7 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
19.0%
4/21 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
General disorders
Fatigue
|
54.8%
17/31 • Number of events 24 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
50.0%
15/30 • Number of events 17 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
61.9%
13/21 • Number of events 18 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Blood and lymphatic system disorders
Anemia
|
58.1%
18/31 • Number of events 32 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
46.7%
14/30 • Number of events 29 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
52.4%
11/21 • Number of events 22 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
Platelet count decreased
|
61.3%
19/31 • Number of events 37 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
30.0%
9/30 • Number of events 18 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
33.3%
7/21 • Number of events 13 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Diarrhea
|
45.2%
14/31 • Number of events 23 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
23.3%
7/30 • Number of events 11 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
52.4%
11/21 • Number of events 18 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Nausea
|
38.7%
12/31 • Number of events 19 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
26.7%
8/30 • Number of events 12 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
42.9%
9/21 • Number of events 12 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.3%
10/31 • Number of events 14 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
36.7%
11/30 • Number of events 13 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
28.6%
6/21 • Number of events 7 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Infections and infestations
Upper respiratory infection
|
29.0%
9/31 • Number of events 15 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
33.3%
10/30 • Number of events 14 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Nervous system disorders
Headache
|
16.1%
5/31 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 7 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
28.6%
6/21 • Number of events 11 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
Alkaline phosphatase increased
|
16.1%
5/31 • Number of events 8 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 8 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
23.8%
5/21 • Number of events 10 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Nervous system disorders
Dizziness
|
16.1%
5/31 • Number of events 8 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 7 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
28.6%
6/21 • Number of events 9 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.7%
3/31 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
33.3%
7/21 • Number of events 10 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
29.0%
9/31 • Number of events 12 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
General disorders
Fever
|
19.4%
6/31 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
20.0%
6/30 • Number of events 7 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.6%
7/31 • Number of events 7 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
4/31 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
28.6%
6/21 • Number of events 11 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.1%
5/31 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
19.0%
4/21 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Metabolism and nutrition disorders
Anorexia
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
6.7%
2/30 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
28.6%
6/21 • Number of events 9 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Constipation
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
6.7%
2/30 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
28.6%
6/21 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Vascular disorders
Hypertension
|
29.0%
9/31 • Number of events 17 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
19.4%
6/31 • Number of events 8 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Psychiatric disorders
Insomnia
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Endocrine disorders
Hypothyroidism
|
6.5%
2/31 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 8 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
19.0%
4/21 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
28.6%
6/21 • Number of events 12 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.9%
4/31 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.7%
3/31 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 8 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.7%
3/31 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 7 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
General disorders
Pain
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Psychiatric disorders
Anxiety
|
16.1%
5/31 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.9%
4/31 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Dry mouth
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
19.0%
4/21 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Nervous system disorders
Dysgeusia
|
9.7%
3/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
23.8%
5/21 • Number of events 6 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
General disorders
Chills
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
6.7%
2/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.5%
2/31 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
23.8%
5/21 • Number of events 9 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.9%
4/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Infections and infestations
Lung infection
|
16.1%
5/31 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
6.7%
2/30 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
16.7%
5/30 • Number of events 9 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.2%
1/31 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Nervous system disorders
Paresthesia
|
6.5%
2/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
19.0%
4/21 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.7%
3/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.5%
2/31 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.1%
5/31 • Number of events 5 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.7%
3/31 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
6.7%
2/30 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Investigations
Weight loss
|
3.2%
1/31 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
19.0%
4/21 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.7%
3/31 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
6.7%
2/30 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Ear and labyrinth disorders
Hearing impaired
|
9.7%
3/31 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
9.5%
2/21 • Number of events 2 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
General disorders
Edema limbs
|
3.2%
1/31 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
13.3%
4/30 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Infections and infestations
Sinusitis
|
9.7%
3/31 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
4.8%
1/21 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.7%
3/31 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
3.3%
1/30 • Number of events 1 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
10.0%
3/30 • Number of events 4 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/21 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/31 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
0.00%
0/30 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
14.3%
3/21 • Number of events 3 • Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place