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NCT01947140 · OUTCOME

Overall Response Rate (ORR) of Subjects Who Received Combination of Pralatrexate and Romidepsin in Phase 1

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies · Source last updated 2026-09-16

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 1.5 years

What was measured

ORR was defined as the number of subjects in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. A partial response is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response is the disappearance of all signs of cancer in the body. In a clinical trial, measuring the ORR is one way to see how well a new treatment works.

Groups in this outcome

Pralatrexate 10 mg/m2, Romidepsin 12 mg/m2

Cohort 1, Dose Level -1 Subjects will be administered through IV: Pralatrexate 10 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.

Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2

Cohort 2A, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.

Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2

Cohort 2B, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.

Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2

Cohort 3A, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 14 mg/m2 on days 1 and 8 of each 21 day cycle.

Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2

Cohort 3B, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 14 mg/m2 on days 1 and 15 of each 28 day cycle.

Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2

Cohort 4A, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.

Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2

Cohort 4B, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.

Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2

Cohort 5B, Dose Level 4 Subjects will be administered through IV: Pralatrexate 25 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Pralatrexate 10 mg/m2, Romidepsin 12 mg/m23
Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m23
Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m23
Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m23
Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m23
Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m25
Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m23
Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m26

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate 10 mg/m2, Romidepsin 12 mg/m22Not reportedNot reportedNot reportedNot reported
Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m23Not reportedNot reportedNot reportedNot reported
Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m22Not reportedNot reportedNot reportedNot reported
Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m22Not reportedNot reportedNot reportedNot reported
Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m21Not reportedNot reportedNot reportedNot reported
Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m22Not reportedNot reportedNot reportedNot reported
Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. 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
        1
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      6
    units
    Participants
description
ORR was defined as the number of subjects in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. A partial response is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response is the disappearance of all signs of cancer in the body. In a clinical trial, measuring the ORR is one way to see how well a new treatment works.
groups
  1. description
    Cohort 1, Dose Level -1 Subjects will be administered through IV: Pralatrexate 10 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    OG000
    title
    Pralatrexate 10 mg/m2, Romidepsin 12 mg/m2
  2. description
    Cohort 2A, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    OG001
    title
    Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
  3. description
    Cohort 2B, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    OG002
    title
    Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
  4. description
    Cohort 3A, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 14 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    OG003
    title
    Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
  5. description
    Cohort 3B, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 14 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    OG004
    title
    Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
  6. description
    Cohort 4A, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    OG005
    title
    Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
  7. description
    Cohort 4B, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    OG006
    title
    Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
  8. description
    Cohort 5B, Dose Level 4 Subjects will be administered through IV: Pralatrexate 25 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    OG007
    title
    Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 1.5 years
title
Overall Response Rate (ORR) of Subjects Who Received Combination of Pralatrexate and Romidepsin in Phase 1
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice