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NCT04447027 · OUTCOME

Maximum Tolerated Dose (MTD)

Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies · Source last updated 2026-08-13

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

Measure
NUMBER
Unit
mg/day
Interval / dispersion
Not reported
Time frame
21 days

What was measured

The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22).

Groups in this outcome

All Participants

All participants who completed at least one cycle (21 days) of treatment.

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

Analysis denominator · Participants

GroupSource count
All Participants26

Reported measurements

Source class 1
Values in mg/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22).
groups
  1. description
    All participants who completed at least one cycle (21 days) of treatment.
    id
    OG000
    title
    All Participants
param Type
NUMBER
reporting Status
POSTED
time Frame
21 days
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg/day

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

Preserved source evidence · Not medical advice