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NCT04447027 · OUTCOME

Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
up to a median of 13.1 months

What was measured

PFS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Progressive disease is \>20% increase in the sum of longest diameters of target lesions. Disease relapse is defined as new areas of disease or \>50% increase in growth of target lesion.

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

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide5.3Not reported4.85.8Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide1.7Not reported1.42.0Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation LenalidomideNANot reportedNANAThe median was not reached as there were not enough events.
Arm 1, Cohort 1, Dose Level 3 Dose Escalation3.7Not reported3.14.3Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide9.2Not reported8.610.0Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide3.6Not reported3.33.9Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide13.1Not reported13.113.1Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide3.4Not reported3.03.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.8
        upper Limit
        5.8
        value
        5.3
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        2.0
        value
        1.7
      3. comment
        The median was not reached as there were not enough events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. group Id
        OG003
        lower Limit
        3.1
        upper Limit
        4.3
        value
        3.7
      5. group Id
        OG004
        lower Limit
        8.6
        upper Limit
        10.0
        value
        9.2
      6. group Id
        OG005
        lower Limit
        3.3
        upper Limit
        3.9
        value
        3.6
      7. group Id
        OG006
        lower Limit
        13.1
        upper Limit
        13.1
        value
        13.1
      8. group Id
        OG007
        lower Limit
        3.0
        upper Limit
        3.8
        value
        3.4
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
PFS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Progressive disease is \>20% increase in the sum of longest diameters of target lesions. Disease relapse is defined as new areas of disease or \>50% increase in growth of target lesion.
dispersion Type
95% Confidence Interval
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
MEDIAN
reporting Status
POSTED
time Frame
up to a median of 13.1 months
title
Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice