Trial · NCT00057811
Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
NCT00057811, Phase 2, Completed, Children's Oncology Group; results first posted 2014-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma. Trials, record NCT00057811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00057811
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
- NCT number
- NCT00057811
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Untreated Childhood Acute Lymphoblastic Leukemia
- Interventions
doxorubicin hydrochloride, cyclophosphamide, methotrexate, rasburicase, leucovorin calcium, prednisone, methylprednisolone, filgrastim, rituximab, cytarabine, etoposide, vincristine sulfate, hydrocortisone sodium succinate, laboratory biomarker analysis
- First posted
- 2003-04-09
- Last updated
- 2014-09-19
- Results first posted
- 2014-08-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Grade ≥ 3 Stomatitis | Up to 1 year | 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 |
| Primary | Response Rate | Up to 5 years | 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.. |
| Primary | Minimal Residual Disease | Not Provided | 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). |
| Primary | Toxic Death | Up to 1 year | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Grade ≥ 3 Stomatitis | Up to 1 year | 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. | participants | NUMBER |
| PRIMARY | Response Rate | Up to 5 years | Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response). | percentage of participants analyzed | NUMBER |
| PRIMARY | Minimal Residual Disease | Not Provided | Population analyzed included patients submitting samples for minimal disease assay at end induction | percentage of samples analyzed | NUMBER |
| PRIMARY | Toxic Death | Up to 1 year | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Grade ≥ 3 Stomatitis | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | Incidence of grade ≥ 3 stomatitis | 4 | participants | |
| Grade ≥ 3 Stomatitis | Group C (Chemotherapy, Monoclonal Antibody Therapy) | Incidence of grade ≥ 3 stomatitis | 6 | participants | |
| Grade ≥ 3 Stomatitis | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | No incidence of grade ≥ 3 stomatitis | 41 | participants | |
| Grade ≥ 3 Stomatitis | Group C (Chemotherapy, Monoclonal Antibody Therapy) | No incidence of grade ≥ 3 stomatitis | 34 | participants | |
| Response Rate | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 88 | 95% Confidence Interval 71 to 96 | percentage of participants analyzed | |
| Response Rate | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 83 | 95% Confidence Interval 61 to 95 | percentage of participants analyzed | |
| Minimal Residual Disease | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 22 | 95% Confidence Interval 11 to 40 | percentage of samples analyzed | |
| Minimal Residual Disease | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 70 | 95% Confidence Interval 35 to 93 | percentage of samples analyzed | |
| Toxic Death | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | Toxic death | 0 | participants | |
| Toxic Death | Group C (Chemotherapy, Monoclonal Antibody Therapy) | Toxic death | 2 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 51 | |
| Overall Study | STARTED | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 46 | |
| Overall Study | COMPLETED | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 41 | |
| Overall Study | COMPLETED | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 34 | |
| Overall Study | NOT COMPLETED | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 10 | |
| Overall Study | NOT COMPLETED | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 12 |
Source ClinicalTrials.gov
Adverse events456
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 32 | 46 | 32 |
| other | Anemia | Blood and lymphatic system disorders | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 32 | 42 | 32 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 0 | 46 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 1 | 42 | 1 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 0 | 46 | 0 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 1 | 42 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 0 | 46 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 1 | 42 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 18 | 46 | 18 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 22 | 42 | 22 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | ||
| Total, all-cause mortality | Group C (Chemotherapy, Monoclonal Antibody Therapy) | ||
| Total, other adverse events | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 32 | 46 |
| Total, other adverse events | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 35 | 42 |
| Total, serious adverse events | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 2 | 46 |
| Total, serious adverse events | Group C (Chemotherapy, Monoclonal Antibody Therapy) | 6 | 42 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) vs Group C (Chemotherapy, Monoclonal Antibody Therapy): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00057811
GET https://conductscience.org/api/trials/v1/NCT00057811/events?page=2