Skip to content
TriangleGet started
← Full study record

NCT01724177 · OUTCOME

Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)

A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma · Source last updated 2018-05-29

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
95% Confidence Interval
Time frame
From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

What was measured

ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared

Analysis population: The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide

Groups in this outcome

Lenalidomide

Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity

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

Analysis denominator · Participants

GroupSource count
Lenalidomide26

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide42.3Not reported23.35263.082Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest: H0: ORR ≤ 5% versus H1: ORR \> 5%
    statistical Method
    Exact Test
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest: H0: ORR ≤ 5% versus H1: ORR \> 5%
    statistical Method
    Exact Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.352
        upper Limit
        63.082
        value
        42.3
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
    id
    OG000
    title
    Lenalidomide
param Type
NUMBER
population Description
The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
reporting Status
POSTED
time Frame
From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
title
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice