Trial · NCT00004228
Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
NCT00004228, Phase 3, Completed, Children's Oncology Group; results first posted 2013-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma. Trials, record NCT00004228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
- NCT number
- NCT00004228
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 393 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Lymphoma
- Interventions
asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone, doxorubicin hydrochloride, leucovorin calcium, mercaptopurine, methotrexate, prednisone, thioguanine, vincristine sulfate, radiation therapy
- First posted
- 2003-01-27
- Last updated
- 2019-08-06
- Results first posted
- 2013-12-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival | 5 years | Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification. |
| Secondary | Percentage of Patients With Overall Survival as Assessed by Time to Death | 5 years | Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival | 5 years | There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis. | percentage of particpants | NUMBER |
| SECONDARY | Percentage of Patients With Overall Survival as Assessed by Time to Death | 5 years | There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival | A0 (Localized Disease Stg I/II) Modified CCG BFM | 88 | 95% Confidence Interval 76 to 95 | percentage of particpants | |
| Event-free Survival | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 82 | 95% Confidence Interval 70 to 90 | percentage of particpants | |
| Event-free Survival | A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens | 80 | 95% Confidence Interval 67 to 89 | percentage of particpants | |
| Event-free Survival | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | 63 | 95% Confidence Interval 29 to 85 | percentage of particpants | |
| Event-free Survival | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | 82 | 95% Confidence Interval 70 to 89 | percentage of particpants | |
| Event-free Survival | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | 84 | 95% Confidence Interval 72 to 91 | percentage of particpants | |
| Event-free Survival | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | 90 | 95% Confidence Interval 78 to 96 | percentage of particpants | |
| Percentage of Patients With Overall Survival as Assessed by Time to Death | A0 (Localized Disease Stg I/II) Modified CCG BFM | 96 | 95% Confidence Interval 84 to 99 | percentage of participants | |
| Percentage of Patients With Overall Survival as Assessed by Time to Death | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 84 | 95% Confidence Interval 72 to 91 | percentage of participants | |
| Percentage of Patients With Overall Survival as Assessed by Time to Death | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | 88 | 95% Confidence Interval 76 to 94 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A0 (Localized Disease Stg I/II) Modified CCG BFM | 60 | |
| Overall Study | STARTED | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 66 | |
| Overall Study | STARTED | A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens | 65 | |
| Overall Study | STARTED | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | 13 | |
| Overall Study | STARTED | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | 67 | |
| Overall Study | STARTED | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | 65 | |
| Overall Study | STARTED | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | 57 | |
| Overall Study | COMPLETED | A0 (Localized Disease Stg I/II) Modified CCG BFM | 51 | |
| Overall Study | COMPLETED | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 51 | |
| Overall Study | COMPLETED | A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens | 46 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,519
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 | Allergic reaction/hypersensitivity | Immune system disorders | A0 (Localized Disease Stg I/II) Modified CCG BFM | 1 | 56 | 2 |
| other | Allergic reaction/hypersensitivity | Immune system disorders | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 4 | 64 | 5 |
| other | Allergic reaction/hypersensitivity | Immune system disorders | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | 1 | 61 | 1 |
| other | Allergic reaction/hypersensitivity | Immune system disorders | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | 1 | 12 | 1 |
| other | Allergic reaction/hypersensitivity | Immune system disorders | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | 3 | 66 | 4 |
| other | Allergic reaction/hypersensitivity | Immune system disorders | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | 3 | 63 | 3 |
| other | Allergic reaction/hypersensitivity | Immune system disorders | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | 1 | 52 | 1 |
| other | Autoimmune reaction | Immune system disorders | A0 (Localized Disease Stg I/II) Modified CCG BFM | 0 | 56 | 0 |
| other | Autoimmune reaction | Immune system disorders | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 1 | 64 | 1 |
| other | Autoimmune reaction | Immune system disorders | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | 0 | 61 | 0 |
1 to 10 of 1,519Source ClinicalTrials.gov
See all 1,519 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A0 (Localized Disease Stg I/II) Modified CCG BFM | ||
| Total, all-cause mortality | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | ||
| Total, all-cause mortality | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | ||
| Total, all-cause mortality | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | ||
| Total, all-cause mortality | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | ||
| Total, all-cause mortality | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | ||
| Total, all-cause mortality | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | ||
| Total, other adverse events | A0 (Localized Disease Stg I/II) Modified CCG BFM | 56 | 56 |
| Total, other adverse events | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 64 | 64 |
| Total, other adverse events | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | 60 | 61 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00004228
GET https://conductscience.org/api/trials/v1/NCT00004228/flow?page=2