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NCT00644189 · OUTCOME

Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)

Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma · Source last updated 2023-03-15

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
after at most 6 28-day cycles

What was measured

To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Analysis population: Phase I participants only who were treated at the RP2D (3mg)

Groups in this outcome

Phase I

Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 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
Phase I16

Reported measurements

Source class 1

Complete Response (CR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I5Not reportedNot reportedNot reportedNot reported

Partial Response (PR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I4Not reportedNot reportedNot reportedNot reported

Stable Disease (SD) or Progressive Disease (PD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      title
      Complete Response (CR)
    2. measurements
      1. group Id
        OG000
        value
        4
      title
      Partial Response (PR)
    3. measurements
      1. group Id
        OG000
        value
        7
      title
      Stable Disease (SD) or Progressive Disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
    id
    OG000
    title
    Phase I
param Type
COUNT_OF_PARTICIPANTS
population Description
Phase I participants only who were treated at the RP2D (3mg)
reporting Status
POSTED
time Frame
after at most 6 28-day cycles
title
Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice