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NCT01823198 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    id
    FG003
    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
    FG004
    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
    FG005
    title
    Phase II: NK Cell Dose Level 4_ 10^8
  7. description
    Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
    id
    FG006
    title
    Donors
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        21
      7. group Id
        FG006
        num Subjects
        21
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        18
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Sixty three participants were enrolled in MDACC which 42 recipients and 21 related donors have signed consents. Twenty one ex-vivo NK cell derived from cord blood are from MDACC cord blood bank.
recruitment Details
Participants were recruited at MD Anderson Cancer Center.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    id
    FG003
    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
    FG004
    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
    FG005
    title
    Phase II: NK Cell Dose Level 4_ 10^8
  7. description
    Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
    id
    FG006
    title
    Donors
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        21
      7. group Id
        FG006
        num Subjects
        21
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        18
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Sixty three participants were enrolled in MDACC which 42 recipients and 21 related donors have signed consents. Twenty one ex-vivo NK cell derived from cord blood are from MDACC cord blood bank.
recruitment Details
Participants were recruited at MD Anderson Cancer Center.

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Preserved source evidence · Not medical advice