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NCT00438802 · OUTCOME

Maximum Tolerated Dose (MTD)

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
mg/kg Alefacept
Interval / dispersion
Not reported
Time frame
8 weeks from registration

What was measured

The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on DLT toxicities encountered during the first 8 weeks of treatment reported in Primary Outcome Measure #1.

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

All Patients

Dose Level 1= 0.15 mg/kg\> Dose Level 2= 0.20 mg/kg\> 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
All Patients21

Reported measurements

Source class 1
Values in mg/kg Alefacept · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients0.30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.30
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on DLT toxicities encountered during the first 8 weeks of treatment reported in Primary Outcome Measure #1.
groups
  1. description
    Dose Level 1= 0.15 mg/kg\> Dose Level 2= 0.20 mg/kg\> 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
    OG000
    title
    All Patients
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
8 weeks from registration
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg/kg Alefacept

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

Preserved source evidence · Not medical advice