Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02232516 · OUTCOME

Objective Response Rate (ORR), as Defined Per Cheson Criteria

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma · Source last updated 2026-06-12

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Assessed after cycles 3 and 6, then every 6 months up to 3 years

What was measured

The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.

Groups in this outcome

Treatment (Romidepsin, Lenalidomide)

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Romidepsin, Lenalidomide)23

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)6Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)9Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)2Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)6Not reportedNot reportedNot reportedNot reported
CR + PR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stable Disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Progressive Disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    CR + PR
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.
groups
  1. description
    Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Treatment (Romidepsin, Lenalidomide)
param Type
NUMBER
reporting Status
POSTED
time Frame
Assessed after cycles 3 and 6, then every 6 months up to 3 years
title
Objective Response Rate (ORR), as Defined Per Cheson Criteria
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice