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NCT02112916 · OUTCOME

Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma · Source last updated 2026-07-29

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
3 years

What was measured

EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups.

Analysis population: As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study. Arms were combined for this analysis as pre-specified in the protocol.

Groups in this outcome

Arm A (Combination Chemotherapy)

Patients receive combination chemotherapy without bortezomib.

Arm B (Combination Chemotherapy, Bortezomib)

Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)

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 A (Combination Chemotherapy)416
Arm B (Combination Chemotherapy, Bortezomib)408

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Combination Chemotherapy)81.7Not reported77.086.4Not reported
Arm B (Combination Chemotherapy, Bortezomib)85.1Not reported80.889.4Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.561
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.091
    estimate Comment
    Hazard ratio = hazard rate for Arm B/hazard rate for Arm A
    group Description
    To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.074
    param Type
    Hazard Ratio (HR)
    param Value
    0.782
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.561
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.091
    estimate Comment
    Hazard ratio = hazard rate for Arm B/hazard rate for Arm A
    group Description
    To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.074
    param Type
    Hazard Ratio (HR)
    param Value
    0.782
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.0
        upper Limit
        86.4
        value
        81.7
      2. group Id
        OG001
        lower Limit
        80.8
        upper Limit
        89.4
        value
        85.1
denoms
  1. counts
    1. group Id
      OG000
      value
      416
    2. group Id
      OG001
      value
      408
    units
    Participants
description
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive combination chemotherapy without bortezomib.
    id
    OG000
    title
    Arm A (Combination Chemotherapy)
  2. description
    Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
    id
    OG001
    title
    Arm B (Combination Chemotherapy, Bortezomib)
param Type
NUMBER
population Description
As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study. Arms were combined for this analysis as pre-specified in the protocol.
reporting Status
POSTED
time Frame
3 years
title
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
type
PRIMARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice