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NCT00295932 · OUTCOME

Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma

Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma · Source last updated 2018-11-20

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

Toxicity assessed using NCI-CTC v. 3.0

Groups in this outcome

1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide

Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide

1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide

Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide

1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide

Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide

1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide

Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide

Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid

Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide

Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid

Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide

Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham

Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide

Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami

Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide

Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham

Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF

Weekly Bortezomib Dosing Schedule

Phase II Randomized Weekly bortezomib dosing schedule

Twice-weekly Bortezomib Dosing Schedule

Phase II Randomized Twice-weekly bortezomib dosing schedule

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

Analysis denominator · Participants

GroupSource count
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide4
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide6
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide3
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide4
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid2
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid18
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham3
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami4
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham10
Weekly Bortezomib Dosing Schedule12
Twice-weekly Bortezomib Dosing Schedule13

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide4Not reportedNot reportedNot reportedNot reported
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide6Not reportedNot reportedNot reportedNot reported
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide3Not reportedNot reportedNot reportedNot reported
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide4Not reportedNot reportedNot reportedNot reported
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid2Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid18Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham3Not reportedNot reportedNot reportedNot reported
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami4Not reportedNot reportedNot reportedNot reported
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham10Not reportedNot reportedNot reportedNot reported
Weekly Bortezomib Dosing Schedule12Not reportedNot reportedNot reportedNot reported
Twice-weekly Bortezomib Dosing Schedule13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        18
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        10
      10. group Id
        OG009
        value
        12
      11. group Id
        OG010
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      18
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      4
    9. group Id
      OG008
      value
      10
    10. group Id
      OG009
      value
      12
    11. group Id
      OG010
      value
      13
    units
    Participants
description
Toxicity assessed using NCI-CTC v. 3.0
groups
  1. description
    Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
    id
    OG000
    title
    1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
  2. description
    Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
    id
    OG001
    title
    1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
  3. description
    Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
    id
    OG002
    title
    1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
  4. description
    Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
    id
    OG003
    title
    1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
  5. description
    Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
    id
    OG004
    title
    Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
  6. description
    Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
    id
    OG005
    title
    Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
  7. description
    Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
    id
    OG006
    title
    Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
  8. description
    Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
    id
    OG007
    title
    Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
  9. description
    Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
    id
    OG008
    title
    Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
  10. description
    Phase II Randomized Weekly bortezomib dosing schedule
    id
    OG009
    title
    Weekly Bortezomib Dosing Schedule
  11. description
    Phase II Randomized Twice-weekly bortezomib dosing schedule
    id
    OG010
    title
    Twice-weekly Bortezomib Dosing Schedule
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice