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NCT01207388 · OUTCOME

Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline and end of cycle 1 (6 weeks)

What was measured

MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10\^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.

Analysis population: Full analysis set participants who were in hematological complete remission at treatment start, with no MRD Response in the first treatment cycle, excluding Philadelphia-positive participants.

Groups in this outcome

Cycle 1 MRD 10^-5

Participants with an MRD level 10\^-5 at the end of cycle 1.

Cycle 1 MRD 10^-4

Participants with an MRD level 10\^-4 at the end of cycle 1.

Cycle 1 MRD 10^-3

Participants with an MRD level 10\^-3 at the end of cycle 1.

Cycle 1 MRD 10^-2

Participants with an MRD level 10\^-2 at the end of cycle 1.

Cycle 1 MRD 10^-1

Participants with an MRD level 10\^-1 at the end of cycle 1.

Cycle 1 MRD Unknown

Participants with an unknown MRD level at the end of cycle 1.

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

Analysis denominator · Participants

GroupSource count
Cycle 1 MRD 10^-52
Cycle 1 MRD 10^-413
Cycle 1 MRD 10^-34
Cycle 1 MRD 10^-20
Cycle 1 MRD 10^-12
Cycle 1 MRD Unknown2

Reported measurements

Baseline MRD Unknown
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 MRD 10^-50Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-41Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-30Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-10Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD Unknown0Not reportedNot reportedNot reportedNot reported
Baseline MRD 10^-5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 MRD 10^-50Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-40Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-30Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-10Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD Unknown0Not reportedNot reportedNot reportedNot reported
Baseline MRD 10^-4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 MRD 10^-50Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-41Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-30Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-10Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD Unknown0Not reportedNot reportedNot reportedNot reported
Baseline MRD 10^-3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 MRD 10^-51Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-46Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-32Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-11Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD Unknown0Not reportedNot reportedNot reportedNot reported
Baseline MRD 10^-2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 MRD 10^-50Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-45Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-32Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-11Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD Unknown0Not reportedNot reportedNot reportedNot reported
Baseline MRD 10^-1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 MRD 10^-51Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-40Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-30Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD 10^-10Not reportedNot reportedNot reportedNot reported
Cycle 1 MRD Unknown2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG004
        value
        0
      5. group Id
        OG005
        value
        0
    title
    Baseline MRD Unknown
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG004
        value
        0
      5. group Id
        OG005
        value
        0
    title
    Baseline MRD 10^-5
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG004
        value
        0
      5. group Id
        OG005
        value
        0
    title
    Baseline MRD 10^-4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
      4. group Id
        OG004
        value
        1
      5. group Id
        OG005
        value
        0
    title
    Baseline MRD 10^-3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        2
      4. group Id
        OG004
        value
        1
      5. group Id
        OG005
        value
        0
    title
    Baseline MRD 10^-2
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG004
        value
        0
      5. group Id
        OG005
        value
        2
    title
    Baseline MRD 10^-1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      2
    units
    Participants
description
MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10\^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.
groups
  1. description
    Participants with an MRD level 10\^-5 at the end of cycle 1.
    id
    OG000
    title
    Cycle 1 MRD 10^-5
  2. description
    Participants with an MRD level 10\^-4 at the end of cycle 1.
    id
    OG001
    title
    Cycle 1 MRD 10^-4
  3. description
    Participants with an MRD level 10\^-3 at the end of cycle 1.
    id
    OG002
    title
    Cycle 1 MRD 10^-3
  4. description
    Participants with an MRD level 10\^-2 at the end of cycle 1.
    id
    OG003
    title
    Cycle 1 MRD 10^-2
  5. description
    Participants with an MRD level 10\^-1 at the end of cycle 1.
    id
    OG004
    title
    Cycle 1 MRD 10^-1
  6. description
    Participants with an unknown MRD level at the end of cycle 1.
    id
    OG005
    title
    Cycle 1 MRD Unknown
param Type
COUNT_OF_PARTICIPANTS
population Description
Full analysis set participants who were in hematological complete remission at treatment start, with no MRD Response in the first treatment cycle, excluding Philadelphia-positive participants.
reporting Status
POSTED
time Frame
Baseline and end of cycle 1 (6 weeks)
title
Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice