TriangleNCT03598998 · STUDY IN CONTEXT
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
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).
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.
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.
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).
Reported safety
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
- nct id
- NCT03598998
- trial label
- Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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