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NCT02104427 · OUTCOME

Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions

PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · Source last updated 2021-04-19

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

Measure
NUMBER
Unit
Proportion of patients
Interval / dispersion
95% Confidence Interval
Time frame
Day 5 to Day 9

What was measured

The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥6.0 x 10\^6 cells/kg was collected within 5 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions.

Analysis population: There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10\^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.

Groups in this outcome

Within 1 Leukapheresis Session

Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 1 leukapheresis session

Within 2 Leukapheresis Sessions

Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 2 leukapheresis session

Within 3 Leukapheresis Sessions

Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 3 leukapheresis session

Within 4 Leukapheresis Sessions

Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 4 leukapheresis session

Within 5 Leukapheresis Sessions

Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 5 leukapheresis session

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

Analysis denominator · Participants

GroupSource count
Within 1 Leukapheresis Session12
Within 2 Leukapheresis Sessions12
Within 3 Leukapheresis Sessions12
Within 4 Leukapheresis Sessions12
Within 5 Leukapheresis Sessions12

Reported measurements

Overall

Analysis denominator · Participants

GroupSource count
Within 1 Leukapheresis Session12
Within 2 Leukapheresis Sessions12
Within 3 Leukapheresis Sessions12
Within 4 Leukapheresis Sessions12
Within 5 Leukapheresis Sessions12
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Within 1 Leukapheresis Session0.5000Not reported0.21090.7891Not reported
Within 2 Leukapheresis Sessions0.6667Not reported0.34890.9008Not reported
Within 3 Leukapheresis Sessions0.6667Not reported0.34890.9008Not reported
Within 4 Leukapheresis Sessions0.6667Not reported0.34890.9008Not reported
Within 5 Leukapheresis Sessions0.6667Not reported0.34890.9008Not reported
Multiple myeloma

Analysis denominator · Participants

GroupSource count
Within 1 Leukapheresis Session9
Within 2 Leukapheresis Sessions9
Within 3 Leukapheresis Sessions9
Within 4 Leukapheresis Sessions9
Within 5 Leukapheresis Sessions9
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Within 1 Leukapheresis Session0.6667Not reported0.29930.9251Not reported
Within 2 Leukapheresis Sessions0.8889Not reported0.51750.9972Not reported
Within 3 Leukapheresis Sessions0.8889Not reported0.51750.9972Not reported
Within 4 Leukapheresis Sessions0.8889Not reported0.51750.9972Not reported
Within 5 Leukapheresis Sessions0.8889Not reported0.51750.9972Not reported
Non-Hodgkin Lymphoma or Hodgkin Disease

Analysis denominator · Participants

GroupSource count
Within 1 Leukapheresis Session3
Within 2 Leukapheresis Sessions3
Within 3 Leukapheresis Sessions3
Within 4 Leukapheresis Sessions3
Within 5 Leukapheresis Sessions3
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Within 1 Leukapheresis Session0.0000Not reported0.00000.0000Not reported
Within 2 Leukapheresis Sessions0.0000Not reported0.00000.0000Not reported
Within 3 Leukapheresis Sessions0.0000Not reported0.00000.0000Not reported
Within 4 Leukapheresis Sessions0.0000Not reported0.00000.0000Not reported
Within 5 Leukapheresis Sessions0.0000Not reported0.00000.0000Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2109
        upper Limit
        0.7891
        value
        0.5000
      2. group Id
        OG001
        lower Limit
        0.3489
        upper Limit
        0.9008
        value
        0.6667
      3. group Id
        OG002
        lower Limit
        0.3489
        upper Limit
        0.9008
        value
        0.6667
      4. group Id
        OG003
        lower Limit
        0.3489
        upper Limit
        0.9008
        value
        0.6667
      5. group Id
        OG004
        lower Limit
        0.3489
        upper Limit
        0.9008
        value
        0.6667
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        12
      units
      Participants
    title
    Overall
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2993
        upper Limit
        0.9251
        value
        0.6667
      2. group Id
        OG001
        lower Limit
        0.5175
        upper Limit
        0.9972
        value
        0.8889
      3. group Id
        OG002
        lower Limit
        0.5175
        upper Limit
        0.9972
        value
        0.8889
      4. group Id
        OG003
        lower Limit
        0.5175
        upper Limit
        0.9972
        value
        0.8889
      5. group Id
        OG004
        lower Limit
        0.5175
        upper Limit
        0.9972
        value
        0.8889
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        9
      units
      Participants
    title
    Multiple myeloma
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0000
        upper Limit
        0.0000
        value
        0.0000
      2. group Id
        OG001
        lower Limit
        0.0000
        upper Limit
        0.0000
        value
        0.0000
      3. group Id
        OG002
        lower Limit
        0.0000
        upper Limit
        0.0000
        value
        0.0000
      4. group Id
        OG003
        lower Limit
        0.0000
        upper Limit
        0.0000
        value
        0.0000
      5. group Id
        OG004
        lower Limit
        0.0000
        upper Limit
        0.0000
        value
        0.0000
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        3
      units
      Participants
    title
    Non-Hodgkin Lymphoma or Hodgkin Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      12
    units
    Participants
description
The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥6.0 x 10\^6 cells/kg was collected within 5 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 1 leukapheresis session
    id
    OG000
    title
    Within 1 Leukapheresis Session
  2. description
    Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 2 leukapheresis session
    id
    OG001
    title
    Within 2 Leukapheresis Sessions
  3. description
    Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 3 leukapheresis session
    id
    OG002
    title
    Within 3 Leukapheresis Sessions
  4. description
    Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 4 leukapheresis session
    id
    OG003
    title
    Within 4 Leukapheresis Sessions
  5. description
    Cumulative CD34+ cell counts ≥6.0 x 10\^6 cells/kg within 5 leukapheresis session
    id
    OG004
    title
    Within 5 Leukapheresis Sessions
param Type
NUMBER
population Description
There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10\^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.
reporting Status
POSTED
time Frame
Day 5 to Day 9
title
Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions
type
SECONDARY
unit Of Measure
Proportion of patients

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

Preserved source evidence · Not medical advice