Skip to content
TriangleGet started
← Full study record

NCT00075946 · FLOW

Participant flow

Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma · Source last updated 2024-02-01

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

groups
  1. description
    Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG000
    title
    Rituximab Retreatment: Follicular Patients
  2. description
    Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG001
    title
    Rituximab Scheduled: Follicular Patients
  3. description
    Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG002
    title
    Rituximab Retreatment: Non-Follicular Patients
  4. description
    Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG003
    title
    Rituximab Scheduled: Non-Follicular Patients
  5. description
    Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
    id
    FG004
    title
    Enrolled But Not Randomized
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        6
      type
      Path ineligible: undetermined histology
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        182
      type
      Did not achieve response after induction
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Incorrectly randomized (no response)
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        58
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Alternative therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Other complicating disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      No response to retreatment
    10. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Time to progression less than 6 months
    11. reasons
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        151
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        188
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        148
      3. group Id
        FG002
        num Subjects
        27
      4. group Id
        FG003
        num Subjects
        29
      5. group Id
        FG004
        num Subjects
        154
      type
      Treated and With Toxicity Data Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        146
      3. group Id
        FG002
        num Subjects
        23
      4. group Id
        FG003
        num Subjects
        29
      5. group Id
        FG004
        num Subjects
        0
      type
      Included in Primary Analysis
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        151
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        188
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients received induction rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms, stratified on histology (follicular vs other), age, and time from diagnosis.
recruitment Details
The study was opened on Nov 21, 2003, accrued its first patient on January 23, 2004, and closed on Sept 12, 2008, with final accrual of 545 patients.
Complete source fields
groups
  1. description
    Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG000
    title
    Rituximab Retreatment: Follicular Patients
  2. description
    Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG001
    title
    Rituximab Scheduled: Follicular Patients
  3. description
    Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG002
    title
    Rituximab Retreatment: Non-Follicular Patients
  4. description
    Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    FG003
    title
    Rituximab Scheduled: Non-Follicular Patients
  5. description
    Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
    id
    FG004
    title
    Enrolled But Not Randomized
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        6
      type
      Path ineligible: undetermined histology
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        182
      type
      Did not achieve response after induction
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Incorrectly randomized (no response)
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        58
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Alternative therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Other complicating disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      No response to retreatment
    10. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Time to progression less than 6 months
    11. reasons
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        151
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        188
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        148
      3. group Id
        FG002
        num Subjects
        27
      4. group Id
        FG003
        num Subjects
        29
      5. group Id
        FG004
        num Subjects
        154
      type
      Treated and With Toxicity Data Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        146
      3. group Id
        FG002
        num Subjects
        23
      4. group Id
        FG003
        num Subjects
        29
      5. group Id
        FG004
        num Subjects
        0
      type
      Included in Primary Analysis
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        151
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        188
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients received induction rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms, stratified on histology (follicular vs other), age, and time from diagnosis.
recruitment Details
The study was opened on Nov 21, 2003, accrued its first patient on January 23, 2004, and closed on Sept 12, 2008, with final accrual of 545 patients.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice