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NCT01419795 · ADVERSE EVENTS

Adverse events

Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant · Source last updated 2017-07-27

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Lenalidomide, Rituximab)

Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

2 / 30 / 3Not reported / Not reported
Arm II (Lenalidomide)

Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

0 / 00 / 0Not reported / Not reported

Group identifiers: EG000: Arm I (Lenalidomide, Rituximab) · EG001: Arm II (Lenalidomide)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Superior vena cava obstruction
  2. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hyperglycemia
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dehydration
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Tumor flare syndrome
  5. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspnea
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Neutropenia
  7. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Rash >50% BSA

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    event Groups
    1. description
      Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      3
      serious Num Affected
      2
      serious Num At Risk
      3
      title
      Arm I (Lenalidomide, Rituximab)
    2. description
      Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Arm II (Lenalidomide)
    frequency Threshold
    5
    serious Events
    1. organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Superior vena cava obstruction
    2. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Hyperglycemia
    3. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Dehydration
    4. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Tumor flare syndrome
    5. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Dyspnea
    6. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Neutropenia
    7. organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Rash >50% BSA

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

    Preserved source evidence · Not medical advice