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NCT01871727 · FLOW

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A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma · Source last updated 2024-11-13

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

groups
  1. description
    Participants were treated with E7777 6 mcg/kg by intravenous (IV) infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    FG000
    title
    Lead-In Part: E7777 6 mcg/kg
  2. description
    Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    FG001
    title
    Lead-In Part: E7777 9 mcg/kg
  3. description
    Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    FG002
    title
    Lead-In Part: E7777 12 mcg/kg
  4. description
    Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
    id
    FG003
    title
    Lead-In Part: E7777 15 mcg/kg
  5. description
    Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Main study part.
    id
    FG004
    title
    Main Study Part: E7777 9 mcg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        The primary efficacy analysis set was defined as participants who had Stage I to III Cutaneous T-Cell Lymphoma (CTCL) at baseline and received E7777 at 9 mcg/kg; this set included 64 participants from the Main Study and 5 participants from the Lead-In part- this set had total 69 participants.
        group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Primary Efficacy Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Lead-In Part (1 Year 2 Months)
  2. drop Withdraws
    1. 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
        2
      type
      Other
    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
        11
      type
      Sponsor Decision
    3. 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
        9
      type
      Withdrawal by Subject
    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
        20
      type
      Disease progression
    5. 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
        2
      type
      Lost to Follow-up
    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
        1
      type
      Not treated
    milestones
    1. achievements
      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
        91
      type
      STARTED
    2. achievements
      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. comment
        The primary efficacy analysis set was defined as participants who had Stage I to III Cutaneous T-Cell Lymphoma (CTCL) at baseline and received E7777 at 9 mcg/kg; this set included 64 participants from the Main Study and 5 participants from the Lead-In part- this set had total 69 participants.
        group Id
        FG004
        num Subjects
        64
      type
      Primary Efficacy Analysis Set
    3. achievements
      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
        46
      type
      COMPLETED
    4. achievements
      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
        45
      type
      NOT COMPLETED
    title
    Main Study Part (2 Years 4 Months)
pre Assignment Details
36 participants were screened in Lead-In Part, out of which 21 were enrolled and treated.143 participants were screened in Main Study Part, out of which 91 were enrolled and 90 were treated. As per planned analysis, data was collectively reported for total 98 participants (Full analysis set/Safety analysis set) from Main Study Part and Lead-In Part who received study drug at 9 micrograms per kilograms (mcg/kg) dose. 8 participants were from Lead-In Part and 90 were from Main Study Part.
recruitment Details
Participants took part in the study at 20 investigative sites in the United States and Australia from 30 May 2013 to 14 December 2021.
Complete source fields
groups
  1. description
    Participants were treated with E7777 6 mcg/kg by intravenous (IV) infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    FG000
    title
    Lead-In Part: E7777 6 mcg/kg
  2. description
    Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    FG001
    title
    Lead-In Part: E7777 9 mcg/kg
  3. description
    Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    FG002
    title
    Lead-In Part: E7777 12 mcg/kg
  4. description
    Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
    id
    FG003
    title
    Lead-In Part: E7777 15 mcg/kg
  5. description
    Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Main study part.
    id
    FG004
    title
    Main Study Part: E7777 9 mcg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        The primary efficacy analysis set was defined as participants who had Stage I to III Cutaneous T-Cell Lymphoma (CTCL) at baseline and received E7777 at 9 mcg/kg; this set included 64 participants from the Main Study and 5 participants from the Lead-In part- this set had total 69 participants.
        group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Primary Efficacy Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Lead-In Part (1 Year 2 Months)
  2. drop Withdraws
    1. 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
        2
      type
      Other
    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
        11
      type
      Sponsor Decision
    3. 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
        9
      type
      Withdrawal by Subject
    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
        20
      type
      Disease progression
    5. 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
        2
      type
      Lost to Follow-up
    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
        1
      type
      Not treated
    milestones
    1. achievements
      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
        91
      type
      STARTED
    2. achievements
      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. comment
        The primary efficacy analysis set was defined as participants who had Stage I to III Cutaneous T-Cell Lymphoma (CTCL) at baseline and received E7777 at 9 mcg/kg; this set included 64 participants from the Main Study and 5 participants from the Lead-In part- this set had total 69 participants.
        group Id
        FG004
        num Subjects
        64
      type
      Primary Efficacy Analysis Set
    3. achievements
      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
        46
      type
      COMPLETED
    4. achievements
      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
        45
      type
      NOT COMPLETED
    title
    Main Study Part (2 Years 4 Months)
pre Assignment Details
36 participants were screened in Lead-In Part, out of which 21 were enrolled and treated.143 participants were screened in Main Study Part, out of which 91 were enrolled and 90 were treated. As per planned analysis, data was collectively reported for total 98 participants (Full analysis set/Safety analysis set) from Main Study Part and Lead-In Part who received study drug at 9 micrograms per kilograms (mcg/kg) dose. 8 participants were from Lead-In Part and 90 were from Main Study Part.
recruitment Details
Participants took part in the study at 20 investigative sites in the United States and Australia from 30 May 2013 to 14 December 2021.

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Preserved source evidence · Not medical advice