Trial · NCT00059839
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
NCT00059839, Phase 3, Completed, Children's Oncology Group; results first posted 2013-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma. Trials, record NCT00059839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00059839
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
- NCT number
- NCT00059839
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 129 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Lymphoma
- Interventions
- doxorubicin hydrochloride, mercaptopurine, methotrexate, prednisone, vinblastine sulfate, vincristine sulfate
- First posted
- 2003-05-07
- Last updated
- 2014-09-22
- Results first posted
- 2013-10-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | From first enrollment up to 3 years. | Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) | From first enrollment up to 3 years. | 64 patients from Arm I were analyzed for this outcome measure, one patient was deemed ineligible. 61 patients from Arm II were analyzed for this outcome measure, three patients were deemed ineligible. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) | Standard (APO) With Vincristine (Arm I) | 74 | 95% Confidence Interval 61 to 84 | percentage of participants | |
| Event-free Survival (EFS) | Consolidation (Includes Vinblastine) (Arm II) | 79 | 95% Confidence Interval 65 to 87 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard (APO) With Vincristine (Arm I) | 65 | |
| Overall Study | STARTED | Consolidation (Includes Vinblastine) (Arm II) | 64 | |
| Overall Study | COMPLETED | Standard (APO) With Vincristine (Arm I) | 53 | |
| Overall Study | COMPLETED | Consolidation (Includes Vinblastine) (Arm II) | 47 | |
| Overall Study | NOT COMPLETED | Standard (APO) With Vincristine (Arm I) | 12 | |
| Overall Study | NOT COMPLETED | Consolidation (Includes Vinblastine) (Arm II) | 17 |
Source ClinicalTrials.gov
Adverse events314
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 | Standard (APO) With Vincristine (Arm I) | 14 | 64 | 14 |
| other | Anemia | Blood and lymphatic system disorders | Consolidation (Includes Vinblastine) (Arm II) | 24 | 61 | 24 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Standard (APO) With Vincristine (Arm I) | 0 | 64 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Consolidation (Includes Vinblastine) (Arm II) | 1 | 61 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Standard (APO) With Vincristine (Arm I) | 7 | 64 | 7 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Consolidation (Includes Vinblastine) (Arm II) | 18 | 61 | 18 |
| other | Cardiac disorders - Other | Cardiac disorders | Standard (APO) With Vincristine (Arm I) | 2 | 64 | 2 |
| other | Cardiac disorders - Other | Cardiac disorders | Consolidation (Includes Vinblastine) (Arm II) | 0 | 61 | 0 |
| other | Conduction disorder | Cardiac disorders | Standard (APO) With Vincristine (Arm I) | 1 | 64 | 1 |
| other | Conduction disorder | Cardiac disorders | Consolidation (Includes Vinblastine) (Arm II) | 0 | 61 | 0 |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard (APO) With Vincristine (Arm I) | ||
| Total, all-cause mortality | Consolidation (Includes Vinblastine) (Arm II) | ||
| Total, other adverse events | Standard (APO) With Vincristine (Arm I) | 47 | 64 |
| Total, other adverse events | Consolidation (Includes Vinblastine) (Arm II) | 52 | 61 |
| Total, serious adverse events | Standard (APO) With Vincristine (Arm I) | 2 | 64 |
| Total, serious adverse events | Consolidation (Includes Vinblastine) (Arm II) | 4 | 61 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25156886 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Standard (APO) With Vincristine (Arm I) vs Consolidation (Includes Vinblastine) (Arm II): 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/NCT00059839
GET https://conductscience.org/api/trials/v1/NCT00059839/events?page=2