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NCT00561418 · OUTCOME

Time to Progression

Vorinostat After Stem Cell Transplant in Treating Patients With High-Risk Lymphoma · Source last updated 2015-07-16

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 3 years

What was measured

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Analysis population: Unable to calculate time to progression for patients due to not enough follow up time

Groups in this outcome

Vorinostat (SAHA)

Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)

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

Analysis denominator · Participants

GroupSource count
Vorinostat (SAHA)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
groups
  1. description
    Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)
    id
    OG000
    title
    Vorinostat (SAHA)
population Description
Unable to calculate time to progression for patients due to not enough follow up time
reporting Status
POSTED
time Frame
Up to 3 years
title
Time to Progression
type
SECONDARY

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

Preserved source evidence · Not medical advice