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NCT01822886 · OUTCOME

Complete Remission (CR) Rate

Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients · Source last updated 2019-10-14

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
18 months

What was measured

Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"

Groups in this outcome

Romidepsin, Gemcitabine

Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.

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

Analysis denominator · Participants

GroupSource count
Romidepsin, Gemcitabine20

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin, Gemcitabine3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"
groups
  1. description
    Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.
    id
    OG000
    title
    Romidepsin, Gemcitabine
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
18 months
title
Complete Remission (CR) Rate
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice