Trial · NCT00118209

Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

NCT00118209, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2020-04-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma. Trials, record NCT00118209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118209

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
NCT number: NCT00118209
Status: Completed
Phases: Phase 3
Enrollment: 524 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Large B Cell Lymphoma
Interventions: rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, etoposide, filgrastim, pegfilgrastim
First posted: 2005-07-11
Last updated: 2021-11-17
Results first posted: 2020-04-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival Rate at 2 and 5 Years	Up to 5 years post-registration	Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse\> * ≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.\> * Appearance of any new lesion during or after completion of therapy.\> * PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.\> The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below.
Secondary	Response Rate	Up to 5 years post-registration	The overall response rate is defined as the percentage of participants with a response (Complete Response or Partial Response)
Secondary	Overall Survival Rate at 2 and 5 Years	Up to 5 years post-registration	Overall survival is defined as the time from randomization to death due to any cause. The overall survival (OS) rate (percentage of participants who are still alive) at 2 and 5 years Kaplan Meier estimates and 95% confidence intervals are reported below.
Other	Whether the Gene Expression Signatures That Were Previously Associated With Survival Following CHOP Therapy Are Associated With Survival in Either of the Treatment Arms of the Prospective Trial	Up to 5 years post-registration

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Progression-Free Survival Rate at 2 and 5 Years	Up to 5 years post-registration	percentage of participants	NUMBER
SECONDARY	Response Rate	Up to 5 years post-registration	percentage of participants	NUMBER
SECONDARY	Overall Survival Rate at 2 and 5 Years	Up to 5 years post-registration	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Whether the Gene Expression Signatures That Were Previously Associated With Survival Following CHOP Therapy Are Associated With Survival in Either of the Treatment Arms of the Prospective Trial	Up to 5 years post-registration

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival Rate at 2 and 5 Years	Arm B - DA-EPOCH-R	2-year PFS	78.9	95% Confidence Interval 73.8 to 84.2	percentage of participants
Progression-Free Survival Rate at 2 and 5 Years	Arm A - R-CHOP	2-year PFS	75.5	95% Confidence Interval 70.2 to 81.1	percentage of participants
Progression-Free Survival Rate at 2 and 5 Years	Arm B - DA-EPOCH-R	5-year PFS	68.0	95% Confidence Interval 62.1 to 74.5	percentage of participants
Progression-Free Survival Rate at 2 and 5 Years	Arm A - R-CHOP	5-year PFS	66.0	95% Confidence Interval 60.2 to 72.5	percentage of participants
Response Rate	Arm B - DA-EPOCH-R		86.7		percentage of participants
Response Rate	Arm A - R-CHOP		88.0		percentage of participants
Overall Survival Rate at 2 and 5 Years	Arm B - DA-EPOCH-R	2-year OS rate	86.5	95% Confidence Interval 82.3 to 91.0	percentage of participants
Overall Survival Rate at 2 and 5 Years	Arm A - R-CHOP	2-year OS rate	85.7	95% Confidence Interval 81.4 to 90.2	percentage of participants
Overall Survival Rate at 2 and 5 Years	Arm B - DA-EPOCH-R	5-year OS rate	77.5	95% Confidence Interval 72.2 to 83.2	percentage of participants
Overall Survival Rate at 2 and 5 Years	Arm A - R-CHOP	5-year OS rate	78.5	95% Confidence Interval 73.4 to 83.9	percentage of participants

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A - R-CHOP	262
Overall Study	STARTED	Arm B - DA-EPOCH-R	262
Overall Study	Evaluable for Primary Endpoint	Arm A - R-CHOP	250
Overall Study	Evaluable for Primary Endpoint	Arm B - DA-EPOCH-R	241
Overall Study	Evaluable for Safety Analysis	Arm A - R-CHOP	243
Overall Study	Evaluable for Safety Analysis	Arm B - DA-EPOCH-R	237
Overall Study	COMPLETED	Arm A - R-CHOP	250
Overall Study	COMPLETED	Arm B - DA-EPOCH-R	241
Overall Study	NOT COMPLETED	Arm A - R-CHOP	12
Overall Study	NOT COMPLETED	Arm B - DA-EPOCH-R	21

Source ClinicalTrials.gov

Adverse events846

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	Blood disorder	Blood and lymphatic system disorders	Arm A - R-CHOP	1	243	1
other	Blood disorder	Blood and lymphatic system disorders	Arm B - DA-EPOCH-R	0	237	0
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm A - R-CHOP	26	243	27
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm B - DA-EPOCH-R	44	237	57
other	Hemoglobin decreased	Blood and lymphatic system disorders	Arm A - R-CHOP	80	243	126
other	Hemoglobin decreased	Blood and lymphatic system disorders	Arm B - DA-EPOCH-R	116	237	199
other	Lymphatic disorder	Blood and lymphatic system disorders	Arm A - R-CHOP	1	243	1
other	Lymphatic disorder	Blood and lymphatic system disorders	Arm B - DA-EPOCH-R	1	237	1
other	Asystole	Cardiac disorders	Arm A - R-CHOP	0	243	0
other	Asystole	Cardiac disorders	Arm B - DA-EPOCH-R	1	237	1

1 to 10 of 846Source ClinicalTrials.gov

See all 846 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A - R-CHOP	53	250
Total, all-cause mortality	Arm B - DA-EPOCH-R	56	241
Total, other adverse events	Arm A - R-CHOP	94	243
Total, other adverse events	Arm B - DA-EPOCH-R	119	237
Total, serious adverse events	Arm A - R-CHOP	232	243
Total, serious adverse events	Arm B - DA-EPOCH-R	214	237

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22180164	DERIVED	PubMed
30939090	DERIVED	PubMed
32232481	DERIVED	PubMed
39809075	DERIVED	PubMed

Grants2

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	Source
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA031946	Cancer and Leukemia Group B	BERTAGNOLLI, MONICA M	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A - R-CHOP vs Arm B - DA-EPOCH-R: deaths from any cause	Trial comparisons
Arm A - R-CHOP vs Arm B - DA-EPOCH-R: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00118209

GET https://conductscience.org/api/trials/v1/NCT00118209/events?page=2

API reference For AI assistants