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NCT00416351 · OUTCOME

Response Rate for Participants With Non-Hodgkin's Lymphoma

Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment · Source last updated 2022-05-17

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
2 years

What was measured

Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)

Analysis population: Evaluable participants with Non-Hodgkin's Lymphoma

Groups in this outcome

4 mg/m2/Day Clofarabine

Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.

8 mg/m2/Day Clofarabine

Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 8 mg/m2/day and will be escalated to higher dose levels.

13.2 mg/m2/Day Clofarabine

Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 13.2 mg/m2/day and will be escalated to higher dose levels.

20 mg/m2/Day Clofarabine

Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels.

28 mg/m2/Day Clofarabine

Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels.

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

Analysis denominator · Participants

GroupSource count
4 mg/m2/Day Clofarabine1
8 mg/m2/Day Clofarabine3
13.2 mg/m2/Day Clofarabine4
20 mg/m2/Day Clofarabine17
28 mg/m2/Day Clofarabine4

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
4 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
8 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
13.2 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
20 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
28 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported

Partial Response (PR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
4 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
8 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
13.2 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
20 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
28 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported

Stable Disease (SD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
4 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
8 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
13.2 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
20 mg/m2/Day Clofarabine2Not reportedNot reportedNot reportedNot reported
28 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported

Progression of Disease (POD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
4 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
8 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
13.2 mg/m2/Day Clofarabine2Not reportedNot reportedNot reportedNot reported
20 mg/m2/Day Clofarabine11Not reportedNot reportedNot reportedNot reported
28 mg/m2/Day Clofarabine3Not reportedNot reportedNot reportedNot reported

Not Evaluable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
4 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
8 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
13.2 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
20 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
28 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported

Stable Disease/Progression of Disease (SD/POD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
4 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
8 mg/m2/Day Clofarabine0Not reportedNot reportedNot reportedNot reported
13.2 mg/m2/Day Clofarabine1Not reportedNot reportedNot reportedNot reported
20 mg/m2/Day Clofarabine2Not reportedNot reportedNot reportedNot reported
28 mg/m2/Day Clofarabine0Not 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
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      title
      Partial Response (PR)
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      title
      Stable Disease (SD)
    4. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        3
      title
      Progression of Disease (POD)
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      title
      Not Evaluable
    6. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      title
      Stable Disease/Progression of Disease (SD/POD)
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      17
    5. group Id
      OG004
      value
      4
    units
    Participants
description
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
groups
  1. description
    Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
    id
    OG000
    title
    4 mg/m2/Day Clofarabine
  2. description
    Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 8 mg/m2/day and will be escalated to higher dose levels.
    id
    OG001
    title
    8 mg/m2/Day Clofarabine
  3. description
    Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 13.2 mg/m2/day and will be escalated to higher dose levels.
    id
    OG002
    title
    13.2 mg/m2/Day Clofarabine
  4. description
    Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels.
    id
    OG003
    title
    20 mg/m2/Day Clofarabine
  5. description
    Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels.
    id
    OG004
    title
    28 mg/m2/Day Clofarabine
param Type
COUNT_OF_PARTICIPANTS
population Description
Evaluable participants with Non-Hodgkin's Lymphoma
reporting Status
POSTED
time Frame
2 years
title
Response Rate for Participants With Non-Hodgkin's Lymphoma
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice