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NCT02653976 · OUTCOME

Tumor Response (Central Assessment)

A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-01-26

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months.

What was measured

Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response.

Analysis population: Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).

Groups in this outcome

SP-02L (Darinaparsin for Injection)

SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days

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

Analysis denominator · Participants

GroupSource count
SP-02L (Darinaparsin for Injection)57

Reported measurements

Overall Response Rate
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
SP-02L (Darinaparsin for Injection)19.3Not reported11.229.9Not reported
Disease Control Rate
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
SP-02L (Darinaparsin for Injection)45.6Not reported34.357.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.2
        upper Limit
        29.9
        value
        19.3
    title
    Overall Response Rate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.3
        upper Limit
        57.3
        value
        45.6
    title
    Disease Control Rate
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    units
    Participants
description
Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response.
dispersion Type
90% Confidence Interval
groups
  1. description
    SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
    id
    OG000
    title
    SP-02L (Darinaparsin for Injection)
param Type
NUMBER
population Description
Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).
reporting Status
POSTED
time Frame
Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months.
title
Tumor Response (Central Assessment)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice