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NCT01076543 · OUTCOME

Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only

Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma · Source last updated 2019-10-16

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
28 days

What was measured

Incidence of dose-limiting toxicity (DLT) defined as any grade 3 or 4 adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)

Analysis population: Only phase I patients were assessed for dose-limiting toxicity per 3+3 dose-escalation design to determine the maximum tolerated dose (MTD).

Groups in this outcome

Phase I, All Histologies, Lenalidomide 15 mg

Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .

Phase I, All Histologies, Lenalidomide 20 mg

Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .

Phase I, All Histologies, Lenalidomide 25 mg

Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .

Phase II, Diffuse Large B-Cell Subtype

Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .

Phase II, Follicular Subtype

Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .

Phase II, Lymphoma NOS

Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression 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
Phase I, All Histologies, Lenalidomide 15 mg6
Phase I, All Histologies, Lenalidomide 20 mg3
Phase I, All Histologies, Lenalidomide 25 mg6
Phase II, Diffuse Large B-Cell Subtype0
Phase II, Follicular Subtype0
Phase II, Lymphoma NOS0

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I, All Histologies, Lenalidomide 15 mg1Not reportedNot reportedNot reportedNot reported
Phase I, All Histologies, Lenalidomide 20 mg0Not reportedNot reportedNot reportedNot reported
Phase I, All Histologies, Lenalidomide 25 mg3Not reportedNot reportedNot reportedNot reported
Phase II, Diffuse Large B-Cell Subtype0Not reportedNot reportedNot reportedNot reported
Phase II, Follicular Subtype0Not reportedNot reportedNot reportedNot reported
Phase II, Lymphoma NOS0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    The maximum tolerated dose (MTD) was determined using the traditional "3+3" design and was the maximum dose level such that less than 33% of the patients (i.e, \<1 of 3 or \<2 of 6) experience dose-limiting toxicity.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    param Type
    Maximum tolerated dose in mg
    param Value
    20
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    The maximum tolerated dose (MTD) was determined using the traditional "3+3" design and was the maximum dose level such that less than 33% of the patients (i.e, \<1 of 3 or \<2 of 6) experience dose-limiting toxicity.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    param Type
    Maximum tolerated dose in mg
    param Value
    20
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
Incidence of dose-limiting toxicity (DLT) defined as any grade 3 or 4 adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
groups
  1. description
    Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
    id
    OG000
    title
    Phase I, All Histologies, Lenalidomide 15 mg
  2. description
    Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
    id
    OG001
    title
    Phase I, All Histologies, Lenalidomide 20 mg
  3. description
    Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
    id
    OG002
    title
    Phase I, All Histologies, Lenalidomide 25 mg
  4. description
    Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
    id
    OG003
    title
    Phase II, Diffuse Large B-Cell Subtype
  5. description
    Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
    id
    OG004
    title
    Phase II, Follicular Subtype
  6. description
    Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
    id
    OG005
    title
    Phase II, Lymphoma NOS
param Type
COUNT_OF_PARTICIPANTS
population Description
Only phase I patients were assessed for dose-limiting toxicity per 3+3 dose-escalation design to determine the maximum tolerated dose (MTD).
reporting Status
POSTED
time Frame
28 days
title
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice