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NCT01947140 · OUTCOME

Maximum Tolerated Dose (MTD) of the Combination of Pralatrexate and Romidepsin in Phase 1

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies · Source last updated 2026-09-16

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

Measure
NUMBER
Unit
mg/m2
Interval / dispersion
Not reported
Time frame
Up to 1.5 years

What was measured

The MTD was defined as the dose level at which one-third or fewer patients experienced a dose limiting toxicity. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.

Groups in this outcome

Phase I: Schedule A

Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 8 of each 21-day cycle.

Phase I: Schedule B

Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 15 of each 28-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase I: Schedule A11
Phase I: Schedule B15

Reported measurements

Pralatrexate
Values in mg/m2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: Schedule A15Not reportedNot reportedNot reportedNot reported
Phase I: Schedule BNANot reportedNot reportedNot reportedThe MTD for schedule B was not reached because no DLTs were observed for schedule B.
Romidepsin
Values in mg/m2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: Schedule A12Not reportedNot reportedNot reportedNot reported
Phase I: Schedule BNANot reportedNot reportedNot reportedThe MTD for schedule B was not reached because no DLTs were observed for schedule B.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. comment
        The MTD for schedule B was not reached because no DLTs were observed for schedule B.
        group Id
        OG001
        value
        NA
    title
    Pralatrexate
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. comment
        The MTD for schedule B was not reached because no DLTs were observed for schedule B.
        group Id
        OG001
        value
        NA
    title
    Romidepsin
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      15
    units
    Participants
description
The MTD was defined as the dose level at which one-third or fewer patients experienced a dose limiting toxicity. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.
groups
  1. description
    Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 8 of each 21-day cycle.
    id
    OG000
    title
    Phase I: Schedule A
  2. description
    Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 15 of each 28-day cycle.
    id
    OG001
    title
    Phase I: Schedule B
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 1.5 years
title
Maximum Tolerated Dose (MTD) of the Combination of Pralatrexate and Romidepsin in Phase 1
type
PRIMARY
unit Of Measure
mg/m2

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Preserved source evidence · Not medical advice