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← Childhood Acute Lymphoblastic Leukemia

NCT00057811 · STUDY IN CONTEXT

Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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 incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences

Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.

→

primary · POSTED

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present..

Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).

→

primary · POSTED

The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).

Population analyzed included patients submitting samples for minimal disease assay at end induction

→

primary · POSTED

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.

Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.

→

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-pediatric
nct id
NCT00057811
trial label
Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0000
    source section id
    NCT00057811-om-0000
    source outcome index
    0
    endpoint
    Grade ≥ 3 Stomatitis
    endpoint definition
    The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences
    time origin
    Up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.
    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-pediatric
    nct id
    NCT00057811
    outcome key
    om-0001
    source section id
    NCT00057811-om-0001
    source outcome index
    1
    endpoint
    Response Rate
    endpoint definition
    Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present..
    time origin
    Up to 5 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).
    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-pediatric
    nct id
    NCT00057811
    outcome key
    om-0002
    source section id
    NCT00057811-om-0002
    source outcome index
    2
    endpoint
    Minimal Residual Disease
    endpoint definition
    The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).
    time origin
    Not Provided
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Population analyzed included patients submitting samples for minimal disease assay at end induction
    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-pediatric
    nct id
    NCT00057811
    outcome key
    om-0003
    source section id
    NCT00057811-om-0003
    source outcome index
    3
    endpoint
    Toxic Death
    endpoint definition
    Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.
    time origin
    Up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.
    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-pediatric
    nct id
    NCT00057811
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
    regimen
    Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
    analyzed count
    45
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
    regimen
    Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
    regimen
    Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
    analyzed count
    32
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
    regimen
    Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
    regimen
    Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
    analyzed count
    32
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
    regimen
    Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
    regimen
    Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
    analyzed count
    45
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
    regimen
    Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057811-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00057811
    harm key
    EG000
    source section id
    NCT00057811-ae
    event group key
    EG000
    event group label
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
    serious affected
    2
    serious at risk
    46
    other affected
    32
    other at risk
    46
    frequency threshold
    0
    collection period
    Source null
    event definition
    For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
    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-pediatric
    nct id
    NCT00057811
    harm key
    EG001
    source section id
    NCT00057811-ae
    event group key
    EG001
    event group label
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
    serious affected
    6
    serious at risk
    42
    other affected
    35
    other at risk
    42
    frequency threshold
    0
    collection period
    Source null
    event definition
    For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
    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