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NCT01419795 · OUTCOME

Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts

Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant · Source last updated 2017-07-27

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

Measure
NUMBER
Unit
Number of adverse events
Interval / dispersion
Not reported
Time frame
Assessed up to 30 days after completion of study treatment

Analysis population: No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.

Groups in this outcome

Arm I (Lenalidomide, Rituximab)

Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

Arm II (Lenalidomide)

Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Arm I (Lenalidomide, Rituximab)3
Arm II (Lenalidomide)0

Reported measurements

Source class 1
Values in Number of adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Lenalidomide, Rituximab)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      0
    units
    Participants
groups
  1. description
    Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Arm I (Lenalidomide, Rituximab)
  2. description
    Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
    id
    OG001
    title
    Arm II (Lenalidomide)
param Type
NUMBER
population Description
No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.
reporting Status
POSTED
time Frame
Assessed up to 30 days after completion of study treatment
title
Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts
type
SECONDARY
unit Of Measure
Number of adverse events

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

Preserved source evidence · Not medical advice