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← Doxorubicin Hydrochloride: metastatic acute lymphoblastic leukemia

NCT02112916 · STUDY IN CONTEXT

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 Lympho

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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.

→

secondary · POSTED

Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study.

→

secondary · POSTED

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.

T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\] (who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%

→

secondary · POSTED

Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988

T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\](who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%

→

secondary · POSTED

EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact.

VHR T-ALL patients who had EOC MRD \>= 0.1%, completed the three high-risk blocks of therapy, and had MRD assessment done after the three high-risk blocks. MRD was not performed in T-LLy patients at end of the VHR blocks. MRD is not used in T-LLy to measure disease response. This outcome measure was pre-specified to only be assessed in the T-ALL patients.

→

secondary · POSTED

EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond

VHR T-LL patients who completed the three high-risk blocks of therapy. The T-LLy VHR patients are included in the table, but there were not enough patients to do any formal analysis, eg there was only one patient (n=1) on the study with T-LLy who had radiographic disease assessment after the intensification blocks.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
nct id
NCT02112916
trial label
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 Lympho
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0000
    source section id
    NCT02112916-om-0000
    source outcome index
    0
    endpoint
    Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
    endpoint definition
    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.
    time origin
    3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0001
    source section id
    NCT02112916-om-0001
    source outcome index
    1
    endpoint
    Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase
    endpoint definition
    Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
    time origin
    3 years from start of therapy by patient
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0002
    source section id
    NCT02112916-om-0002
    source outcome index
    2
    endpoint
    EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)
    endpoint definition
    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.
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\] (who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0003
    source section id
    NCT02112916-om-0003
    source outcome index
    3
    endpoint
    Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
    endpoint definition
    Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\](who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0004
    source section id
    NCT02112916-om-0004
    source outcome index
    4
    endpoint
    EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3
    endpoint definition
    EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact.
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    VHR T-ALL patients who had EOC MRD \>= 0.1%, completed the three high-risk blocks of therapy, and had MRD assessment done after the three high-risk blocks. MRD was not performed in T-LLy patients at end of the VHR blocks. MRD is not used in T-LLy to measure disease response. This outcome measure was pre-specified to only be assessed in the T-ALL patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0005
    source section id
    NCT02112916-om-0005
    source outcome index
    5
    endpoint
    EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond
    endpoint definition
    EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    VHR T-LL patients who completed the three high-risk blocks of therapy. The T-LLy VHR patients are included in the table, but there were not enough patients to do any formal analysis, eg there was only one patient (n=1) on the study with T-LLy who had radiographic disease assessment after the intensification blocks.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A (Combination Chemotherapy)
    regimen
    Patients receive combination chemotherapy without bortezomib.
    analyzed count
    416
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B (Combination Chemotherapy, Bortezomib)
    regimen
    Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
    analyzed count
    408
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Total Patients
    regimen
    All the eligible patients enrolled on the study
    analyzed count
    824
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0002
    arm key
    OG000
    arm label
    AALL1231 T-ALL Patients
    regimen
    T-ALL patients on AALL1231 who did not receive prophylactic cranial radiation and did not receive bortezomib: Intermediate Risk T-ALL (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 Low Risk definition).
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0002
    arm key
    OG001
    arm label
    AALL0434 T-ALL Patients
    regimen
    T-ALL patients on AALL0434 \[NCT00408005\] who received prophylactic cranial radiation and did not receive nelarabine (exclude Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%);
    analyzed count
    634
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0002#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0003
    arm key
    OG000
    arm label
    AALL1231 T-ALL Patients
    regimen
    T-ALL patients on AALL1231 who did not receive prophylactic cranial radiation and did not receive bortezomib: Intermediate Risk T-ALL (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 Low Risk definition).
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0003#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0003
    arm key
    OG001
    arm label
    AALL0434 T-ALL Patients
    regimen
    T-ALL patients on AALL0434 \[NCT00408005\] who received prophylactic cranial radiation and did not receive nelarabine (exclude Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%);
    analyzed count
    634
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0003#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0004
    arm key
    OG000
    arm label
    VHR T-ALL MRD Undetectable
    regimen
    VHR T-ALL patients (with end of consolidation \[EOC\] MRD \>= 0.1%) who become MRD negative (MRD undetectable) after the three high-risk BFM blocks of therapy
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0004#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0004
    arm key
    OG001
    arm label
    VHR T-ALL MRD Detectable
    regimen
    VHR T-ALL patients (with end of consolidation \[EOC\] MRD \>= 0.1%) who continue to have detectable MRD after the three high-risk BFM blocks of therapy.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0004#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0005
    arm key
    OG000
    arm label
    VHR T-LLy (CR/PR)
    regimen
    VHR T-LLy patients who achieved complete or partial response (CR/PR) at the end of the high-risk blocks
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0005#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    outcome key
    om-0005
    arm key
    OG001
    arm label
    VHR T-LLy (NR)
    regimen
    VHR T-LLy patients who did not respond (NR) at the end of the high-risk blocks
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02112916-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    harm key
    EG000
    source section id
    NCT02112916-ae
    event group key
    EG000
    event group label
    Arm A (Combination Chemotherapy): T-ALL
    serious affected
    56
    serious at risk
    308
    other affected
    231
    other at risk
    308
    frequency threshold
    0
    collection period
    3 years from start of therapy by patient
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    harm key
    EG001
    source section id
    NCT02112916-ae
    event group key
    EG001
    event group label
    Arm B (Combination Chemotherapy, Bortezomib): T-ALL
    serious affected
    153
    serious at risk
    307
    other affected
    217
    other at risk
    307
    frequency threshold
    0
    collection period
    3 years from start of therapy by patient
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    harm key
    EG002
    source section id
    NCT02112916-ae
    event group key
    EG002
    event group label
    Arm A (Combination Chemotherapy): T-LLy
    serious affected
    25
    serious at risk
    108
    other affected
    86
    other at risk
    108
    frequency threshold
    0
    collection period
    3 years from start of therapy by patient
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-doxorubicin-hydrochloride-f4d6b3fd
    nct id
    NCT02112916
    harm key
    EG003
    source section id
    NCT02112916-ae
    event group key
    EG003
    event group label
    Arm B (Combination Chemotherapy, Bortezomib): T-LLy
    serious affected
    60
    serious at risk
    101
    other affected
    74
    other at risk
    101
    frequency threshold
    0
    collection period
    3 years from start of therapy by patient
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice