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NCT03386513 · FLOW

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Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN · Source last updated 2026-09-04

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

groups
  1. description
    Participants received IMGN632 at a dose of 0.015 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    FG000
    title
    Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
  2. description
    Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG001
    title
    Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
  3. description
    Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG002
    title
    Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
  4. description
    Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG003
    title
    Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
  5. description
    Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG004
    title
    Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
  6. description
    Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG005
    title
    Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
  7. description
    Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
    id
    FG006
    title
    Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
  8. description
    Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
    id
    FG007
    title
    Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
  9. description
    Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
    id
    FG008
    title
    Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
  10. description
    Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG009
    title
    Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
  11. description
    Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG010
    title
    Dose Expansion - Schedule A: IMGN632 0.09 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    3. 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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Sponsor Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Investigator Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        12
      10. group Id
        FG009
        num Subjects
        76
      11. group Id
        FG010
        num Subjects
        9
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Other than Specified
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        13
      11. group Id
        FG010
        num Subjects
        0
      type
      Ongoing in Trial at Time of Data Cutoff
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        14
      10. group Id
        FG009
        num Subjects
        104
      11. group Id
        FG010
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        14
      10. group Id
        FG009
        num Subjects
        104
      11. group Id
        FG010
        num Subjects
        10
      type
      Received at least 1 dose of study drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        14
      10. group Id
        FG009
        num Subjects
        96
      11. group Id
        FG010
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study is ongoing and reports data up to the primary analysis data cut-off date (up to approximately 81 months).
Complete source fields
groups
  1. description
    Participants received IMGN632 at a dose of 0.015 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    FG000
    title
    Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
  2. description
    Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG001
    title
    Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
  3. description
    Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG002
    title
    Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
  4. description
    Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG003
    title
    Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
  5. description
    Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG004
    title
    Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
  6. description
    Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG005
    title
    Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
  7. description
    Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
    id
    FG006
    title
    Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
  8. description
    Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
    id
    FG007
    title
    Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
  9. description
    Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
    id
    FG008
    title
    Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
  10. description
    Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG009
    title
    Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
  11. description
    Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
    id
    FG010
    title
    Dose Expansion - Schedule A: IMGN632 0.09 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    3. 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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Sponsor Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Investigator Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        12
      10. group Id
        FG009
        num Subjects
        76
      11. group Id
        FG010
        num Subjects
        9
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Other than Specified
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        13
      11. group Id
        FG010
        num Subjects
        0
      type
      Ongoing in Trial at Time of Data Cutoff
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        14
      10. group Id
        FG009
        num Subjects
        104
      11. group Id
        FG010
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        14
      10. group Id
        FG009
        num Subjects
        104
      11. group Id
        FG010
        num Subjects
        10
      type
      Received at least 1 dose of study drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        14
      10. group Id
        FG009
        num Subjects
        96
      11. group Id
        FG010
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study is ongoing and reports data up to the primary analysis data cut-off date (up to approximately 81 months).

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

Preserved source evidence · Independent clinical review pending · Not medical advice