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NCT00481871 · OUTCOME

Progression-free Survival (PFS) Time

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies · Source last updated 2020-01-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study

What was measured

PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1).

Groups in this outcome

Phase 1

Includes the Phase 1 dose-finding groups A, B, and C

Phase 2 - Group B

Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.

Phase 2 - Group C

Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.

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 134
Phase 2 - Group B38
Phase 2 - Group C34

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 153.0Not reported49.0106.0Not reported
Phase 2 - Group B59.0Not reported52.099.0Not reported
Phase 2 - Group C54.0Not reported45.089.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.0
        upper Limit
        106.0
        value
        53.0
      2. group Id
        OG001
        lower Limit
        52.0
        upper Limit
        99.0
        value
        59.0
      3. group Id
        OG002
        lower Limit
        45.0
        upper Limit
        89.0
        value
        54.0
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      38
    3. group Id
      OG002
      value
      34
    units
    Participants
description
PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1).
dispersion Type
95% Confidence Interval
groups
  1. description
    Includes the Phase 1 dose-finding groups A, B, and C
    id
    OG000
    title
    Phase 1
  2. description
    Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
    id
    OG001
    title
    Phase 2 - Group B
  3. description
    Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
    id
    OG002
    title
    Phase 2 - Group C
param Type
MEDIAN
reporting Status
POSTED
time Frame
Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study
title
Progression-free Survival (PFS) Time
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice