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NCT00873093 · STUDY IN CONTEXT

Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.

The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.

→

primary · POSTED

Percentage of patients who were event free at 4 months

The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.

→

primary · POSTED

The proportion of toxic death rate among all eligible patients.

The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.

→

primary · POSTED

The proportion of SAE rate among all eligible patients

The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.

→

secondary · POSTED

Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 1.

The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.

→

secondary · POSTED

Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 2.

The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.

→

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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT00873093
trial label
Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
applicability
unclear
applicability note
Attached because the study's own record describes recurrent 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
5
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0000
    source section id
    NCT00873093-om-0000
    source outcome index
    0
    endpoint
    Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy
    endpoint definition
    The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.
    time origin
    The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0001
    source section id
    NCT00873093-om-0001
    source outcome index
    1
    endpoint
    Event Free Survival
    endpoint definition
    Percentage of patients who were event free at 4 months
    time origin
    4 months after enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0002
    source section id
    NCT00873093-om-0002
    source outcome index
    2
    endpoint
    Toxic Death Rate
    endpoint definition
    The proportion of toxic death rate among all eligible patients.
    time origin
    4 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0003
    source section id
    NCT00873093-om-0003
    source outcome index
    3
    endpoint
    Severe Adverse Events (SAE) Rate.
    endpoint definition
    The proportion of SAE rate among all eligible patients
    time origin
    4 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0004
    source section id
    NCT00873093-om-0004
    source outcome index
    4
    endpoint
    Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
    endpoint definition
    Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 1.
    time origin
    End of Block 1 (Day 36 of Block 1) of re-induction therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0005
    source section id
    NCT00873093-om-0005
    source outcome index
    5
    endpoint
    Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2
    endpoint definition
    Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 2.
    time origin
    End of Block 2 (Day 36 of Block 2) of re-induction therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    46
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0000
    arm key
    OG003
    arm label
    T-cell ALL (Chemotherapy)
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0000
    arm key
    OG004
    arm label
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0001#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0001#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    46
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0001#groups/OG002
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0001
    arm key
    OG003
    arm label
    T-cell ALL (Chemotherapy)
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0001#groups/OG003
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0001
    arm key
    OG004
    arm label
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
    regimen
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0001#groups/OG004
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Overall
    regimen
    All enrolled eligible patients.
    analyzed count
    146
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0002#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Overall
    regimen
    All enrolled eligible patients.
    analyzed count
    146
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00873093-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    harm key
    EG000
    source section id
    NCT00873093-ae
    event group key
    EG000
    event group label
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    harm key
    EG001
    source section id
    NCT00873093-ae
    event group key
    EG001
    event group label
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
    serious affected
    47
    serious at risk
    61
    other affected
    58
    other at risk
    61
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    harm key
    EG002
    source section id
    NCT00873093-ae
    event group key
    EG002
    event group label
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
    serious affected
    40
    serious at risk
    49
    other affected
    44
    other at risk
    49
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    harm key
    EG003
    source section id
    NCT00873093-ae
    event group key
    EG003
    event group label
    T-cell ALL (Chemotherapy)
    serious affected
    18
    serious at risk
    22
    other affected
    21
    other at risk
    22
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
    undenominated note
    Source null
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT00873093
    harm key
    EG004
    source section id
    NCT00873093-ae
    event group key
    EG004
    event group label
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
    serious affected
    7
    serious at risk
    10
    other affected
    9
    other at risk
    10
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
    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