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NCT03598998 · FLOW

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Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas · Source last updated 2026-05-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    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.
    id
    FG000
    title
    Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
  2. description
    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.
    id
    FG001
    title
    Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Due to low/slow accrual, this study was permanently closed to accrual after enrolling 13 patients in Phase I, with no accrual in Phase II. Of the 13 patients in Phase I, 7 were at dose level 1 and 6 were at dose level 2.
Complete source fields
groups
  1. description
    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.
    id
    FG000
    title
    Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
  2. description
    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.
    id
    FG001
    title
    Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Due to low/slow accrual, this study was permanently closed to accrual after enrolling 13 patients in Phase I, with no accrual in Phase II. Of the 13 patients in Phase I, 7 were at dose level 1 and 6 were at dose level 2.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice