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NCT01445535 · OUTCOME

Overall Progression Free Survival (PFS)

Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas · Source last updated 2021-11-03

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
On-study date until date of progression or last follow up, approximately 7 months.

What was measured

Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method.

Analysis population: Data collected from participants receiving different dose levels were combined and analyzed as a single Arm/Group as pre-specified in the study protocol.

Groups in this outcome

All Participants

All participants who received 3.4 mg/kg, 4.8 mg/kg, 8.5 mg/kg and 15 mg/kg siplizumab given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 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
All Participants15

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Participants6.8Not reported2.927.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.9
        upper Limit
        27.1
        value
        6.8
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    All participants who received 3.4 mg/kg, 4.8 mg/kg, 8.5 mg/kg and 15 mg/kg siplizumab given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
    id
    OG000
    title
    All Participants
param Type
MEDIAN
population Description
Data collected from participants receiving different dose levels were combined and analyzed as a single Arm/Group as pre-specified in the study protocol.
reporting Status
POSTED
time Frame
On-study date until date of progression or last follow up, approximately 7 months.
title
Overall Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice