Trial · NCT00006721

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

NCT00006721, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2013-02-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma. Trials, record NCT00006721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00006721

On this page

Trial

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

Title: S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma
NCT number: NCT00006721
Status: Completed
Phases: Phase 3
Enrollment: 571 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Lymphoma
Interventions: rituximab, cyclophosphamide, doxorubicin, prednisone, vincristine, tositumomab
First posted: 2003-01-27
Last updated: 2026-03-16
Results first posted: 2013-02-26

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival at 2 Years	0-2 years	Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Primary	Progression-free Survival at 5 Years	0-5 years	Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Primary	Overall Survival at 2 Years	0-2 years	Measured from date of registration to date of death due to any cause
Primary	Overall Survival at 5 Years	0-5 years	Measured from date of registration to date of death due to any cause
Secondary	Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)	Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death	Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Secondary	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival at 2 Years	0-2 years	All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.	percentage of participants	NUMBER
SECONDARY	Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)	Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death	All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.	participants	NUMBER
SECONDARY	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment	Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included	Participants	NUMBER
PRIMARY	Progression-free Survival at 5 Years	0-5 years	All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.	percentage of participants	NUMBER
PRIMARY	Overall Survival at 2 Years	0-2 years	All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.	percentage of participants	NUMBER
PRIMARY	Overall Survival at 5 Years	0-5 years	All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group310

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

Outcome	Group	Category	Value	Units
Progression-free Survival at 2 Years	CHOP + Rituximab		76	percentage of participants
Progression-free Survival at 2 Years	CHOP + Tositumomab		80	percentage of participants
Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)	CHOP + Rituximab		224	participants
Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)	CHOP + Tositumomab		223	participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	CHOP Only	ARDS	0	Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	CHOP + Rituximab	ARDS	0	Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	CHOP + Tositumomab	ARDS	1	Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	CHOP Only	Abdominal pain/cramping	0	Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	CHOP + Rituximab	Abdominal pain/cramping	4	Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	CHOP + Tositumomab	Abdominal pain/cramping	3	Participants

1 to 10 of 310Source ClinicalTrials.gov

See all 310 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CHOP Only	17
Overall Study	STARTED	CHOP + Rituximab	279
Overall Study	STARTED	CHOP + Tositumomab	275
Overall Study	Eligible	CHOP Only	15
Overall Study	Eligible	CHOP + Rituximab	267
Overall Study	Eligible	CHOP + Tositumomab	265
Overall Study	Eligible and Began Protocol Therapy	CHOP Only	14
Overall Study	Eligible and Began Protocol Therapy	CHOP + Rituximab	267
Overall Study	Eligible and Began Protocol Therapy	CHOP + Tositumomab	265
Overall Study	COMPLETED	CHOP Only	13

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events249

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
other	Anemia	Blood and lymphatic system disorders	CHOP Only	5	13
other	Anemia	Blood and lymphatic system disorders	CHOP + Rituximab	177	263
other	Anemia	Blood and lymphatic system disorders	CHOP + Tositumomab	192	263
other	Febrile neutropenia	Blood and lymphatic system disorders	CHOP Only	1	13
other	Febrile neutropenia	Blood and lymphatic system disorders	CHOP + Rituximab	42	263
other	Febrile neutropenia	Blood and lymphatic system disorders	CHOP + Tositumomab	24	263
other	Sinus tachycardia	Cardiac disorders	CHOP Only	1	13
other	Sinus tachycardia	Cardiac disorders	CHOP + Rituximab	0	263
other	Sinus tachycardia	Cardiac disorders	CHOP + Tositumomab	0	263
other	Hypothyroidism	Endocrine disorders	CHOP Only	1	13

1 to 10 of 249Source ClinicalTrials.gov

See all 249 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CHOP Only
Total, all-cause mortality	CHOP + Rituximab
Total, all-cause mortality	CHOP + Tositumomab
Total, other adverse events	CHOP Only	13	13
Total, other adverse events	CHOP + Rituximab	262	263
Total, other adverse events	CHOP + Tositumomab	261	263
Total, serious adverse events	CHOP Only	0	13
Total, serious adverse events	CHOP + Rituximab	3	263
Total, serious adverse events	CHOP + Tositumomab	16	263

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23233710	DERIVED	PubMed
29356608	DERIVED	PubMed
35787017	DERIVED	PubMed
41714403	DERIVED	PubMed
41746629	DERIVED	PubMed

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
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons1

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

Comparison
CHOP + Rituximab vs CHOP + Tositumomab: Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)

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.

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/NCT00006721

GET https://conductscience.org/api/trials/v1/NCT00006721/results?page=2

API reference For AI assistants