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NCT01823198 · OUTCOME

Number of Participants Who Experienced Dose-limiting Toxicities (DLT)

Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies · Source last updated 2023-11-07

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
Up to 42 days

What was measured

Participants that experienced DLT related to the NK Cells post transplant at different dose levels.

Analysis population: Twenty one donor participants were not included in outcome analysis.

Groups in this outcome

Phase I: NK Cell Dose Level 1_10^6

Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.

Phase I: NK Cell Dose Level 2_10^7

Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.

Phase I: NK Cell Dose Level 3_ 3x10^7

Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.

Phase I: NK Cell Dose Level 4_ 10^8

Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.

Phase II: NK Cell Dose Level 3_3x10^7

Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.

Phase II: NK Cell Dose Level 4_ 10^8

Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood

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

Analysis denominator · Participants

GroupSource count
Phase I: NK Cell Dose Level 1_10^66
Phase I: NK Cell Dose Level 2_10^76
Phase I: NK Cell Dose Level 3_ 3x10^74
Phase I: NK Cell Dose Level 4_ 10^84
Phase II: NK Cell Dose Level 3_3x10^71
Phase II: NK Cell Dose Level 4_ 10^821

Reported measurements

Group A: NK cells from KIR mismatched haplo donors
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: NK Cell Dose Level 1_10^62Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 2_10^71Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 3_ 3x10^70Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 4_ 10^80Not reportedNot reportedNot reportedNot reported
Phase II: NK Cell Dose Level 3_3x10^70Not reportedNot reportedNot reportedNot reported
Phase II: NK Cell Dose Level 4_ 10^80Not reportedNot reportedNot reportedNot reported
Group B: NK cells from KIR mismatched cord blood donors
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: NK Cell Dose Level 1_10^62Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 2_10^72Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 3_ 3x10^72Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 4_ 10^82Not reportedNot reportedNot reportedNot reported
Phase II: NK Cell Dose Level 3_3x10^71Not reportedNot reportedNot reportedNot reported
Phase II: NK Cell Dose Level 4_ 10^812Not reportedNot reportedNot reportedNot reported
Group C: NK cells from matched related donors
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: NK Cell Dose Level 1_10^62Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 2_10^73Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 3_ 3x10^72Not reportedNot reportedNot reportedNot reported
Phase I: NK Cell Dose Level 4_ 10^82Not reportedNot reportedNot reportedNot reported
Phase II: NK Cell Dose Level 3_3x10^70Not reportedNot reportedNot reportedNot reported
Phase II: NK Cell Dose Level 4_ 10^89Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Group A: NK cells from KIR mismatched haplo donors
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        12
    title
    Group B: NK cells from KIR mismatched cord blood donors
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        9
    title
    Group C: NK cells from matched related donors
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      21
    units
    Participants
description
Participants that experienced DLT related to the NK Cells post transplant at different dose levels.
groups
  1. description
    Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
    id
    OG000
    title
    Phase I: NK Cell Dose Level 1_10^6
  2. description
    Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
    id
    OG001
    title
    Phase I: NK Cell Dose Level 2_10^7
  3. description
    Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
    id
    OG002
    title
    Phase I: NK Cell Dose Level 3_ 3x10^7
  4. description
    Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
    id
    OG003
    title
    Phase I: NK Cell Dose Level 4_ 10^8
  5. description
    Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
    id
    OG004
    title
    Phase II: NK Cell Dose Level 3_3x10^7
  6. description
    Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood
    id
    OG005
    title
    Phase II: NK Cell Dose Level 4_ 10^8
param Type
COUNT_OF_PARTICIPANTS
population Description
Twenty one donor participants were not included in outcome analysis.
reporting Status
POSTED
time Frame
Up to 42 days
title
Number of Participants Who Experienced Dose-limiting Toxicities (DLT)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice