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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

18 Months

Results posted on

2026-02-12

Participant Flow

Participant milestones

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

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 Months

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.

Outcome measures

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 Months

Survival probability of patients alive 18 months from ASCT, time-to-event

Outcome measures

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 Months

Population: 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

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 months

Number 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

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 months

In patients with measurable disease after ASCT, rate of objective response after treatment. Response was assessed using the Lugano 2014 criteria.

Outcome measures

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 months

Progression-free survival probability of patients who are alive and without progression 18 months from ASCT, time-to-event

Outcome measures

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 months

Survival 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

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 months

Progression-free survival probability of patients alive and disease-free 18 months from ASCT stratified by PET status before transplantation, time-to-event

Outcome measures

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 months

Number of patients who complete the planned treatment

Outcome measures

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 months

Level of MRD detected by PCR (if feasible) before and after pembrolizumab

Outcome measures

Outcome data not reported

Adverse Events

Diffuse Large B Cell Lymphoma

Serious events: 8 serious events
Other events: 29 other events
Deaths: 2 deaths

Classical Hodgkin Lymphoma

Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths

Peripheral T Cell Lymphoma

Serious events: 1 serious events
Other events: 21 other events
Deaths: 3 deaths

Serious adverse events

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

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

Philippe Armand, MD, PhD

Dana-Farber Cancer Institute

Phone: 617-632-2305

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place