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NCT01919619 · OUTCOME

Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant

Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies · Source last updated 2024-12-03

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
Up to 30 days following the last dose of study drugs

What was measured

Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.

Groups in this outcome

Autologous -Treatment (Lenalidomide and Ipilimumab)

Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO

Allogeneic - Treatment (Lenalidomide and Ipilimumab)

Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO

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

Analysis denominator · Participants

GroupSource count
Autologous -Treatment (Lenalidomide and Ipilimumab)28
Allogeneic - Treatment (Lenalidomide and Ipilimumab)13

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Autologous -Treatment (Lenalidomide and Ipilimumab)10Not reportedNot reportedNot reportedNot reported
Allogeneic - Treatment (Lenalidomide and Ipilimumab)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO
    id
    OG000
    title
    Autologous -Treatment (Lenalidomide and Ipilimumab)
  2. description
    Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO
    id
    OG001
    title
    Allogeneic - Treatment (Lenalidomide and Ipilimumab)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 30 days following the last dose of study drugs
title
Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice