NCT03598998 · STUDY IN CONTEXT

Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

Two patients in dose level 1 and one patient in dose level 2 were not evaluable for DLT.

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primary · POSTED

Number of participants who had a documented complete response (CR) or partial response (PR) at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.

Source null

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secondary · POSTED

Number of participants who had a documented complete response at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.

Source null

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secondary · POSTED

Number of Participants who had grade 3 4 5 toxicities at lease possibly related to study treatment. Toxicities were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade refers to the severity of the AE and ranges from 1 to 5 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death).

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-mycosis-fungoides-recurrent-270902ab
nct id: NCT03598998
trial label: Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0000
source section id
NCT03598998-om-0000
source outcome index
0
endpoint
Number of Participants Who Had Dose Limiting Toxicities
endpoint definition
Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
time origin
From the start of Cycle 1 through the start of Cycle 3 (approximately 42 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Two patients in dose level 1 and one patient in dose level 2 were not evaluable for DLT.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0001
source section id
NCT03598998-om-0001
source outcome index
1
endpoint
Number of Participants Who Had Overall Response
endpoint definition
Number of participants who had a documented complete response (CR) or partial response (PR) at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.
time origin
Up to 43 months after the initial study treatment.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0002
source section id
NCT03598998-om-0002
source outcome index
2
endpoint
Number of Participants Who Had Complete Response (CR)
endpoint definition
Number of participants who had a documented complete response at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.
time origin
Up to 43 months after the initial study treatment.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0003
source section id
NCT03598998-om-0003
source outcome index
3
endpoint
Number of Participants With Grade 3 4 5 Adverse Events
endpoint definition
Number of Participants who had grade 3 4 5 toxicities at lease possibly related to study treatment. Toxicities were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade refers to the severity of the AE and ranges from 1 to 5 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death).
time origin
From the start time of the initial treatment assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months).
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0000
arm key
OG000
arm label
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
regimen
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0000
arm key
OG001
arm label
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
regimen
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0001
arm key
OG000
arm label
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
regimen
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0001
arm key
OG001
arm label
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
regimen
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0002
arm key
OG000
arm label
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
regimen
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0002
arm key
OG001
arm label
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
regimen
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0003
arm key
OG000
arm label
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
regimen
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
outcome key
om-0003
arm key
OG001
arm label
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
regimen
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03598998-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
harm key
EG000
source section id
NCT03598998-ae
event group key
EG000
event group label
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
serious affected
2
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mycosis-fungoides-recurrent-270902ab
nct id
NCT03598998
harm key
EG001
source section id
NCT03598998-ae
event group key
EG001
event group label
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice