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NCT00438880 · OUTCOME

Tumor Response

Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma · Source last updated 2016-02-04

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
Evaluations occur every three months up to a year

What was measured

Complete Response (CR): * No measurable or nonmeasurable disease. * No symptoms of Lymphoma. * Non-palpable spleen, if palpable at baseline. * Histologically negative bone marrow, if positive at baseline. * All nodes \<1.5 cm in transverse diameter. Partial Response (PR): * greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions. * No new lesions We are reporting the number of participants that attained a status of CR or PR.

Analysis population: Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.

Groups in this outcome

Phase I

Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15

Phase II

Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15

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

Analysis denominator · Participants

GroupSource count
Phase I0
Phase II8

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II1Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        1
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG001
        value
        0
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Complete Response (CR): * No measurable or nonmeasurable disease. * No symptoms of Lymphoma. * Non-palpable spleen, if palpable at baseline. * Histologically negative bone marrow, if positive at baseline. * All nodes \<1.5 cm in transverse diameter. Partial Response (PR): * greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions. * No new lesions We are reporting the number of participants that attained a status of CR or PR.
groups
  1. description
    Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
    id
    OG000
    title
    Phase I
  2. description
    Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
    id
    OG001
    title
    Phase II
param Type
NUMBER
population Description
Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.
reporting Status
POSTED
time Frame
Evaluations occur every three months up to a year
title
Tumor Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice