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NCT00211185 · OUTCOME

Overall Response in the Intent To Treat (ITT) Population

A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma · Source last updated 2020-03-18

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
Not reported
Time frame
From the start of the treatment to the date of participant's death assessed up to 5 years 9 months

What was measured

Response rate was defined as the percentage of the ITT population who achieved a Complete Response (CR), Unconfirmed Complete Response (CRu), or Partial Response (PR). The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease.

Analysis population: Intent to treat (ITT) population included all participants who signed an informed consent and were deemed eligible to participate by the investigator based on the screening assessments, and started at least 1 cycle of study treatment. It is the same as the Safety Population (SP) for this study.

Groups in this outcome

Denileukin Diftitox in Combination With CHOP

Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.

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

Analysis denominator · Participants

GroupSource count
Denileukin Diftitox in Combination With CHOP49

Reported measurements

Confirmed complete response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denileukin Diftitox in Combination With CHOP51.0Not reportedNot reportedNot reportedNot reported
Unconfirmed complete response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denileukin Diftitox in Combination With CHOP4.1Not reportedNot reportedNot reportedNot reported
Partial response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denileukin Diftitox in Combination With CHOP10.2Not reportedNot reportedNot reportedNot reported
Stable disease
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denileukin Diftitox in Combination With CHOP6.1Not reportedNot reportedNot reportedNot reported
Disease progression
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denileukin Diftitox in Combination With CHOP4.1Not reportedNot reportedNot reportedNot reported
Early death
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denileukin Diftitox in Combination With CHOP4.1Not reportedNot reportedNot reportedNot reported
Inadequate assessment
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denileukin Diftitox in Combination With CHOP20.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        51.0
    title
    Confirmed complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4.1
    title
    Unconfirmed complete response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10.2
    title
    Partial response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6.1
    title
    Stable disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4.1
    title
    Disease progression
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4.1
    title
    Early death
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        20.4
    title
    Inadequate assessment
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
Response rate was defined as the percentage of the ITT population who achieved a Complete Response (CR), Unconfirmed Complete Response (CRu), or Partial Response (PR). The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease.
groups
  1. description
    Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
    id
    OG000
    title
    Denileukin Diftitox in Combination With CHOP
param Type
NUMBER
population Description
Intent to treat (ITT) population included all participants who signed an informed consent and were deemed eligible to participate by the investigator based on the screening assessments, and started at least 1 cycle of study treatment. It is the same as the Safety Population (SP) for this study.
reporting Status
POSTED
time Frame
From the start of the treatment to the date of participant's death assessed up to 5 years 9 months
title
Overall Response in the Intent To Treat (ITT) Population
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice