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NCT00012298 · OUTCOME

Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)

Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2018-08-09

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Assessed up to week 24

What was measured

Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.

Analysis population: All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.

Groups in this outcome

Treatment: Trial 1, Dose Level 1

Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Treatment: Trial 1, Dose Level 2

Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Treatment: Trial 2, Dose Level 3

Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Treatment: Trial 2, Dose Level 4

Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Treatment: Trial 3, Dose Level 5

Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Treatment: Trial 3, Dose Level 6

Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

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

Analysis denominator · Participants

GroupSource count
Treatment: Trial 1, Dose Level 111
Treatment: Trial 1, Dose Level 27
Treatment: Trial 2, Dose Level 39
Treatment: Trial 2, Dose Level 44
Treatment: Trial 3, Dose Level 55
Treatment: Trial 3, Dose Level 66

Reported measurements

Grade 3+ Adverse Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment: Trial 1, Dose Level 19Not reportedNot reportedNot reportedNot reported
Treatment: Trial 1, Dose Level 26Not reportedNot reportedNot reportedNot reported
Treatment: Trial 2, Dose Level 38Not reportedNot reportedNot reportedNot reported
Treatment: Trial 2, Dose Level 44Not reportedNot reportedNot reportedNot reported
Treatment: Trial 3, Dose Level 55Not reportedNot reportedNot reportedNot reported
Treatment: Trial 3, Dose Level 66Not reportedNot reportedNot reportedNot reported
Grade 4+ Adverse Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment: Trial 1, Dose Level 12Not reportedNot reportedNot reportedNot reported
Treatment: Trial 1, Dose Level 25Not reportedNot reportedNot reportedNot reported
Treatment: Trial 2, Dose Level 32Not reportedNot reportedNot reportedNot reported
Treatment: Trial 2, Dose Level 42Not reportedNot reportedNot reportedNot reported
Treatment: Trial 3, Dose Level 51Not reportedNot reportedNot reportedNot reported
Treatment: Trial 3, Dose Level 61Not reportedNot reportedNot reportedNot reported
Grade 5 Adverse Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment: Trial 1, Dose Level 10Not reportedNot reportedNot reportedNot reported
Treatment: Trial 1, Dose Level 20Not reportedNot reportedNot reportedNot reported
Treatment: Trial 2, Dose Level 30Not reportedNot reportedNot reportedNot reported
Treatment: Trial 2, Dose Level 40Not reportedNot reportedNot reportedNot reported
Treatment: Trial 3, Dose Level 50Not reportedNot reportedNot reportedNot reported
Treatment: Trial 3, Dose Level 60Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        6
    title
    Grade 3+ Adverse Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
    title
    Grade 4+ Adverse Event
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Grade 5 Adverse Event
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      6
    units
    Participants
description
Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.
groups
  1. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
    id
    OG000
    title
    Treatment: Trial 1, Dose Level 1
  2. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
    id
    OG001
    title
    Treatment: Trial 1, Dose Level 2
  3. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    OG002
    title
    Treatment: Trial 2, Dose Level 3
  4. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    OG003
    title
    Treatment: Trial 2, Dose Level 4
  5. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    OG004
    title
    Treatment: Trial 3, Dose Level 5
  6. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    OG005
    title
    Treatment: Trial 3, Dose Level 6
param Type
NUMBER
population Description
All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.
reporting Status
POSTED
time Frame
Assessed up to week 24
title
Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice