Trial · NCT00278408
Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
NCT00278408, Phase 3, Completed, German High-Grade Non-Hodgkin's Lymphoma Study Group; results first posted 2025-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma. Trials, record NCT00278408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00278408
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
- NCT number
- NCT00278408
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 700 participants, actual
- Lead sponsor
- German High-Grade Non-Hodgkin's Lymphoma Study Group
- Conditions
- Lymphoma
- Interventions
- filgrastim, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, radiation therapy
- First posted
- 2006-01-18
- Last updated
- 2025-08-26
- Other registries' IDs
- eudract:2005-005218-19
- Results first posted
- 2025-08-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3 Years Event-free Survival | Each patient will be observed for 3 years starting from completion of treatment. | Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first. |
| Secondary | 3 Years Progression-free Survival | Each patient will be observed for 3 years starting from completion of treatment. | Progression of disease is defined as: recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or marked increase in lymphoma manifestation size by more than 25% in comparison with baseline. |
| Secondary | 3 Years Overall Survival | Each patient will be observed for 3 years starting from completion of treatment. | Overall survival was defined as the time from randomization to death of any cause. |
| Secondary | Rate of Complete Remissions and Progressive Disease | Each patient will be observed for 3 years starting from completion of treatment. | |
| Secondary | Number of Patients With a Relapse After a CR/CRu | Each patient will be observed for 3 years starting from completion of treatment. | Relapse is defined as, recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or a marked increase in lymphoma manifestation size by more thyn 25% after at least 2 months CR or CRu from the time point of the final restaging examination |
| Secondary | Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) | Each patient will be observed for 3 years starting from completion of treatment. | |
| Secondary | Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median) | Each patient will be observed for 3 years starting from completion of treatment. | |
| Secondary | Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion | Each patient will be observed for 3 years starting from completion of treatment. | |
| Secondary | Adherence to Protocol - Total Duration of Chemotherapy in Days (Median) | Each patient will be observed for 3 years starting from completion of treatment. | |
| Secondary | Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median) | Each patient will be observed for 3 years starting from completion of treatment. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 3 Years Event-free Survival | Each patient will be observed for 3 years starting from completion of treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 3 Years Progression-free Survival | Each patient will be observed for 3 years starting from completion of treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 3 Years Overall Survival | Each patient will be observed for 3 years starting from completion of treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Complete Remissions and Progressive Disease | Each patient will be observed for 3 years starting from completion of treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With a Relapse After a CR/CRu | Each patient will be observed for 3 years starting from completion of treatment. | Only patients who reached a CR/CRu after at least 2 months after the final restaging examination were taken for the relapse analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) | Each patient will be observed for 3 years starting from completion of treatment. | The number analyzed differs from overall number analyzed due to missing data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median) | Each patient will be observed for 3 years starting from completion of treatment. | mg | MEDIAN | |
| SECONDARY | Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion | Each patient will be observed for 3 years starting from completion of treatment. | The number analyzed differs from overall number analyzed due to missing data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adherence to Protocol - Total Duration of Chemotherapy in Days (Median) | Each patient will be observed for 3 years starting from completion of treatment. | days | MEDIAN | |
| SECONDARY | Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median) | Each patient will be observed for 3 years starting from completion of treatment. | mg/m² | MEDIAN |
Source ClinicalTrials.gov
Results by group174
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 3 Years Event-free Survival | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 51 | Participants | ||
| 3 Years Event-free Survival | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 56 | Participants | ||
| 3 Years Event-free Survival | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 126 | Participants | ||
| 3 Years Event-free Survival | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 123 | Participants | ||
| 3 Years Event-free Survival | Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication | 89 | Participants | ||
| 3 Years Event-free Survival | Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication | 92 | Participants | ||
| 3 Years Progression-free Survival | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 64 | Participants | ||
| 3 Years Progression-free Survival | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 68 | Participants | ||
| 3 Years Progression-free Survival | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 133 | Participants | ||
| 3 Years Progression-free Survival | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 136 | Participants |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 81 | |
| Overall Study | STARTED | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 81 | |
| Overall Study | STARTED | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 155 | |
| Overall Study | STARTED | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 150 | |
| Overall Study | STARTED | Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication | 114 | |
| Overall Study | STARTED | Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication | 114 | |
| Overall Study | COMPLETED | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 77 | |
| Overall Study | COMPLETED | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 79 | |
| Overall Study | COMPLETED | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 133 | |
| Overall Study | COMPLETED | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 135 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events114
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 | Nausea CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 1 | 75 | |
| other | Nausea CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 5 | 75 | |
| other | Nausea CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 7 | 148 | |
| other | Nausea CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 5 | 138 | |
| other | Nausea CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication | 1 | 105 | |
| other | Nausea CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication | 3 | 112 | |
| other | Vomiting CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 1 | 74 | |
| other | Vomiting CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 3 | 75 | |
| other | Vomiting CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 4 | 148 | |
| other | Vomiting CTC 3-5 | Gastrointestinal disorders | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 2 | 137 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 7 | 81 |
| Total, all-cause mortality | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 7 | 81 |
| Total, all-cause mortality | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 15 | 155 |
| Total, all-cause mortality | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 11 | 150 |
| Total, all-cause mortality | Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication | 10 | 114 |
| Total, all-cause mortality | Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication | 11 | 114 |
| Total, other adverse events | Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | 49 | 81 |
| Total, other adverse events | Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | 58 | 81 |
| Total, other adverse events | Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | 98 | 155 |
| Total, other adverse events | Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | 82 | 150 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37427146 | 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 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/NCT00278408
GET https://conductscience.org/api/trials/v1/NCT00278408/results?page=2