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NCT01431209 · FLOW

Participant flow

Ruxolitinib Phosphate to Treat Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Stem Cell Transplant · Source last updated 2023-10-05

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

groups
  1. description
    Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO
    id
    FG000
    title
    Diffuse Large B-cell Lymphoma (DLBCL)
  2. description
    Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO
    id
    FG001
    title
    Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For this study 71 subjects were screened and consented for the study. Nine were considered ineligible by the principal investigator and were not treated and removed from the study. Two other subjects were also not included in the data analysis. One withdrew consent prior to treatment. One was determined to have disease progression before treatment started.
recruitment Details
Evaluable population - Subjects who had completed 2 cycles of therapy with response assessments or progressed before the evaluation of the primary endpoint. Primary endpoint The primary objective of the study is to evaluate subject overall response rate (ORR) after 6 cycles for each of the subject cohorts. The description provided in this section includes the primary analyses for the primary objective.
Complete source fields
groups
  1. description
    Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO
    id
    FG000
    title
    Diffuse Large B-cell Lymphoma (DLBCL)
  2. description
    Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO
    id
    FG001
    title
    Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For this study 71 subjects were screened and consented for the study. Nine were considered ineligible by the principal investigator and were not treated and removed from the study. Two other subjects were also not included in the data analysis. One withdrew consent prior to treatment. One was determined to have disease progression before treatment started.
recruitment Details
Evaluable population - Subjects who had completed 2 cycles of therapy with response assessments or progressed before the evaluation of the primary endpoint. Primary endpoint The primary objective of the study is to evaluate subject overall response rate (ORR) after 6 cycles for each of the subject cohorts. The description provided in this section includes the primary analyses for the primary objective.

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Preserved source evidence · Not medical advice