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NCT00980395 · OUTCOME

Progression-free Survival at 2 Years

Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma · Source last updated 2019-12-30

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

PFS was calculated from the first dose of study drug to the first documentation of disease progression, death regardless of cause, or change in therapy due to disease progression, whichever occurred first. If disease progression did not occur by the end of treatment, patients were evaluated every 3 months until progression with physical examination, laboratory studies, and conventional computed tomographic imaging, up to a maximum of 2 years. The Kaplan-Meier product-limit method will be used to estimate progression-free survival in the presence of censoring.

Groups in this outcome

VCR (Velcade, Cladribine and Rituximab)

* Rituximab 375 mg/m2 IV day1 * Cladribine 4 mg/m2 IV over 2 hours days 1-5 * Bortezomib 1.3 mg/m2 IV days 1 and 4 * Repeat every 28 days for a maximum of 6 cycles rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles. bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles. cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days 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
VCR (Velcade, Cladribine and Rituximab)23

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VCR (Velcade, Cladribine and Rituximab)15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
PFS was calculated from the first dose of study drug to the first documentation of disease progression, death regardless of cause, or change in therapy due to disease progression, whichever occurred first. If disease progression did not occur by the end of treatment, patients were evaluated every 3 months until progression with physical examination, laboratory studies, and conventional computed tomographic imaging, up to a maximum of 2 years. The Kaplan-Meier product-limit method will be used to estimate progression-free survival in the presence of censoring.
groups
  1. description
    * Rituximab 375 mg/m2 IV day1 * Cladribine 4 mg/m2 IV over 2 hours days 1-5 * Bortezomib 1.3 mg/m2 IV days 1 and 4 * Repeat every 28 days for a maximum of 6 cycles rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles. bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles. cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
    id
    OG000
    title
    VCR (Velcade, Cladribine and Rituximab)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Progression-free Survival at 2 Years
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice