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NCT02213913 · OUTCOME

Progression-free Survival at 2 Years

Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas · Source last updated 2026-03-11

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
2 years

What was measured

Percentage of patients alive and progression-free at 2 years.

Groups in this outcome

Treatment (Lenalidomide 10 mg, DA-EPOCH-R)

Phase I Cohort 1: INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV

Treatment (Lenalidomide 15 mg, DA-EPOCH-R)

Phase I Cohort 2: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV

Treatment (Lenalidomide 20 mg, DA-EPOCH-R)

Phase I Cohort 3: INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV

Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)

Phase II Cohort 4: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)3
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)7
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)5
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)40

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)66.7Not reported5.494.5Not reported
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)71.4Not reported25.892.0Not reported
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)100Not reported47.8100Not reported
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)77.5Not reported61.287.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.4
        upper Limit
        94.5
        value
        66.7
      2. group Id
        OG001
        lower Limit
        25.8
        upper Limit
        92.0
        value
        71.4
      3. group Id
        OG002
        lower Limit
        47.8
        upper Limit
        100
        value
        100
      4. group Id
        OG003
        lower Limit
        61.2
        upper Limit
        87.6
        value
        77.5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      40
    units
    Participants
description
Percentage of patients alive and progression-free at 2 years.
dispersion Type
95% Confidence Interval
groups
  1. description
    Phase I Cohort 1: INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
    id
    OG000
    title
    Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
  2. description
    Phase I Cohort 2: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
    id
    OG001
    title
    Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
  3. description
    Phase I Cohort 3: INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
    id
    OG002
    title
    Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
  4. description
    Phase II Cohort 4: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
    id
    OG003
    title
    Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Progression-free Survival at 2 Years
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice