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NCT00438802 · OUTCOME

Clinical Response

Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma · Source last updated 2019-08-13

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
up to 12 cycles (28 days per cycle) of treatment.

What was measured

Treatment response and evaluation will be performed using standardized lymphoma International Working Group recommendations.\> \> A Complete Response (CR) requires:\> * Complete disappearance of all detectable clinical and radiographic evidence of\> disease.\> * All lymph nodes and nodal masses must have regressed to normal size.\> Partial Response (PR):\> * greater than 50% decrease in Sum of Product Dimensions of the six largest dominant nodes, nodal masses, or skin lesions.\> * No increase in size of other nodes\> * no new sites of disease.

Analysis population: Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.

Groups in this outcome

Dose Level 1

Starting Dose Level 1= 0.15 mg/kg\> Each cycle is 4 weeks.\> \> Cycle 1 and 2:\> Alefacept by IV Weekly\> \> Cycles 3-12:\> Alefacept by IV 1 x every 4 weeks

Dose Level 2

Dose Level 2= 0.20 mg/kg\> Each cycle is 4 weeks.\> \> Cycle 1 and 2:\> Alefacept by IV Weekly\> \> Cycles 3-12:\> Alefacept by IV 1 x every 4 weeks

Dose Level 3

Dose Level 3= 0.30 mg/kg\> Each cycle is 4 weeks.\> \> Cycle 1 and 2:\> Alefacept by IV Weekly\> \> Cycles 3-12:\> Alefacept by IV 1 x every 4 weeks

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

Analysis denominator · Participants

GroupSource count
Dose Level 16
Dose Level 26
Dose Level 39

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 11Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Dose Level 30Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 12Not reportedNot reportedNot reportedNot reported
Dose Level 21Not reportedNot reportedNot reportedNot reported
Dose Level 30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      9
    units
    Participants
description
Treatment response and evaluation will be performed using standardized lymphoma International Working Group recommendations.\> \> A Complete Response (CR) requires:\> * Complete disappearance of all detectable clinical and radiographic evidence of\> disease.\> * All lymph nodes and nodal masses must have regressed to normal size.\> Partial Response (PR):\> * greater than 50% decrease in Sum of Product Dimensions of the six largest dominant nodes, nodal masses, or skin lesions.\> * No increase in size of other nodes\> * no new sites of disease.
groups
  1. description
    Starting Dose Level 1= 0.15 mg/kg\> Each cycle is 4 weeks.\> \> Cycle 1 and 2:\> Alefacept by IV Weekly\> \> Cycles 3-12:\> Alefacept by IV 1 x every 4 weeks
    id
    OG000
    title
    Dose Level 1
  2. description
    Dose Level 2= 0.20 mg/kg\> Each cycle is 4 weeks.\> \> Cycle 1 and 2:\> Alefacept by IV Weekly\> \> Cycles 3-12:\> Alefacept by IV 1 x every 4 weeks
    id
    OG001
    title
    Dose Level 2
  3. description
    Dose Level 3= 0.30 mg/kg\> Each cycle is 4 weeks.\> \> Cycle 1 and 2:\> Alefacept by IV Weekly\> \> Cycles 3-12:\> Alefacept by IV 1 x every 4 weeks
    id
    OG002
    title
    Dose Level 3
param Type
NUMBER
population Description
Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.
reporting Status
POSTED
time Frame
up to 12 cycles (28 days per cycle) of treatment.
title
Clinical Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice