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NCT00438802 · OUTCOME

Dose Limiting Toxicity (DLT)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
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 toxicities encountered during the first 8 weeks of treatment.\> \> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria:\> * grade 4 toxicity for neutrophils (\<0.5 x 109/L) or platelets (\<25 x 109/L)\> * any grade 3 or higher solid organ toxicity not explainable by another obvious cause.\> * more than 10 x ULN AST toxicity for more than 14 days\> * any grade 4 infection.\> The number of patients who reported a dose limiting toxicity is reported here.

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

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

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 10Not reportedNot reportedNot reportedNot reported
Dose Level 21Not reportedNot reportedNot reportedNot reported
Dose Level 31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      9
    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 toxicities encountered during the first 8 weeks of treatment.\> \> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria:\> * grade 4 toxicity for neutrophils (\<0.5 x 109/L) or platelets (\<25 x 109/L)\> * any grade 3 or higher solid organ toxicity not explainable by another obvious cause.\> * more than 10 x ULN AST toxicity for more than 14 days\> * any grade 4 infection.\> The number of patients who reported a dose limiting toxicity is reported here.
groups
  1. description
    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
COUNT_OF_PARTICIPANTS
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
Dose Limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice