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NCT02213913 · OUTCOME

Dose-limiting Toxicity (Phase I)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 21 days

What was measured

Number of patients with dose-limiting toxicity (DLT) defined as any grade 4 non-hemaotologic toxicity or any recurrent grade 3 non-hematologic toxicity despite optimal medical management

Analysis population: One patient in cohort 2 was non-evaluable for dose-limiting toxicity.

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

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)6
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)0Not reportedNot reportedNot reportedNot reported
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)0Not reportedNot reportedNot reportedNot reported
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)2Not 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
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Number of patients with dose-limiting toxicity (DLT) defined as any grade 4 non-hemaotologic toxicity or any recurrent grade 3 non-hematologic toxicity despite optimal medical management
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)
param Type
COUNT_OF_PARTICIPANTS
population Description
One patient in cohort 2 was non-evaluable for dose-limiting toxicity.
reporting Status
POSTED
time Frame
Up to 21 days
title
Dose-limiting Toxicity (Phase I)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice