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NCT04447027 · OUTCOME

Number of Participants With a Dose-limiting Toxicity (DLT)

Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies · Source last updated 2026-08-13

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
Day -7 until end of cycle 1 (normally day 22)

What was measured

A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22). Grade 4 is life threatening, and Grade 5 is death related to adverse event. Serious toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

Groups in this outcome

Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

Arm 1, Cohort 1, Dose Level 3 Dose Escalation

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.

Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.

Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.

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

Analysis denominator · Participants

GroupSource count
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide2
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide6
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide6
Arm 1, Cohort 1, Dose Level 3 Dose Escalation3
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide3
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide2
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide1
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide3

Reported measurements

Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation00Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        00
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
    title
    Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      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
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
    title
    Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      2
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      3
    units
    Participants
description
A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22). Grade 4 is life threatening, and Grade 5 is death related to adverse event. Serious toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
groups
  1. description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    OG000
    title
    Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
  2. description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    OG001
    title
    Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
  3. description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    OG002
    title
    Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
  4. description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    OG003
    title
    Arm 1, Cohort 1, Dose Level 3 Dose Escalation
  5. description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    OG004
    title
    Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
  6. description
    T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
    id
    OG005
    title
    Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
  7. description
    T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
    id
    OG006
    title
    Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
  8. description
    T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
    id
    OG007
    title
    Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day -7 until end of cycle 1 (normally day 22)
title
Number of Participants With a Dose-limiting Toxicity (DLT)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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Preserved source evidence · Not medical advice