Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      30

   2. group Id

      BG001

      value

      8

   3. group Id

      BG002

      value

      38

   units

   Participants

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

   BG000

   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

   BG001

   title

   Phase II

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            36

            upper Limit

            80

            value

            60.5

         2. group Id

            BG001

            lower Limit

            42

            upper Limit

            83

            value

            68.5

         3. group Id

            BG002

            lower Limit

            36

            upper Limit

            83

            value

            62.5

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            13

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            17

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            17

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            21

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            30

         2. group Id

            BG001

            value

            8

         3. group Id

            BG002

            value

            38

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

population Description

All participants accrued to this study were analyzed for baseline characteristics

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Preserved source evidence · Not medical advice