Trial · NCT00376961

S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT00376961, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2013-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma. Trials, record NCT00376961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00376961

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Trial

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

Title: S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
NCT number: NCT00376961
Status: Completed
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Lymphoma
Interventions: rituximab, bortezomib, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate
First posted: 2006-09-15
Last updated: 2017-11-06
Results first posted: 2013-02-05

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)	0-2 years	Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.
Secondary	Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment	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	2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)	0-2 years	Measured from date of registration to date of death due to any cause or last contact
Secondary	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment	All eligible patients who started treatment were included in the analysis.	participants	NUMBER
PRIMARY	2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)	0-2 years	All eligible patients who started treatment were included in the analysis	percentage of participants	NUMBER
SECONDARY	2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)	0-2 years	All eligible patients who started treatment were included in the analysis.	percentage of participants	NUMBER
SECONDARY	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.	Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 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

Source ClinicalTrials.gov

Results by group98

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

Outcome	Group	Category	Value	Spread	Units
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	R-CHOP-V Followed by VM	Complete Response	17		participants
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	R-CHOP-V Followed by VM	Partial Response	16		participants
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	R-CHOP-V Followed by VM	Unconfirmed Complete Response	13		participants
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	R-CHOP-V Followed by VM	Unconfirmed Partial Response	1		participants
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	R-CHOP-V Followed by VM	No Response	4		participants
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).	R-CHOP-V Followed by VM	Assessment Inadequate	14		participants
2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)	R-CHOP-V Followed by VM		62	95% Confidence Interval 49 to 72	percentage of participants
2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)	R-CHOP-V Followed by VM		85	95% Confidence Interval 73 to 91	percentage of participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	Albumin, serum-low (hypoalbuminemia)	1		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Bortezomib Maintenance (VM)	Albumin, serum-low (hypoalbuminemia)	0		Participants

1 to 10 of 98Source ClinicalTrials.gov

See all 98 results by group

Participant flow16

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

Period	Milestone	Group	Participants
Initial Registration	STARTED	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	68
Initial Registration	STARTED	Bortezomib Maintenance (VM)	0
Initial Registration	Eligible	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	65
Initial Registration	Eligible	Bortezomib Maintenance (VM)	0
Initial Registration	COMPLETED	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	61
Initial Registration	COMPLETED	Bortezomib Maintenance (VM)	0
Initial Registration	NOT COMPLETED	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	7
Initial Registration	NOT COMPLETED	Bortezomib Maintenance (VM)	0
Maintenance	STARTED	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	0
Maintenance	STARTED	Bortezomib Maintenance (VM)	50

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events144

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	Febrile neutropenia	Blood and lymphatic system disorders	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	12	65
other	Febrile neutropenia	Blood and lymphatic system disorders	Bortezomib Maintenance (VM)	0	47
other	Hemoglobin	Blood and lymphatic system disorders	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	47	65
other	Hemoglobin	Blood and lymphatic system disorders	Bortezomib Maintenance (VM)	15	47
other	Auditory/Ear-Other (Specify)	Ear and labyrinth disorders	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	0	65
other	Auditory/Ear-Other (Specify)	Ear and labyrinth disorders	Bortezomib Maintenance (VM)	3	47
other	Vision-blurred vision	Eye disorders	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	9	65
other	Vision-blurred vision	Eye disorders	Bortezomib Maintenance (VM)	0	47
other	Watery eye (epiphora, tearing)	Eye disorders	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	6	65
other	Watery eye (epiphora, tearing)	Eye disorders	Bortezomib Maintenance (VM)	0	47

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction
Total, all-cause mortality	Bortezomib Maintenance (VM)
Total, other adverse events	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	64	65
Total, other adverse events	Bortezomib Maintenance (VM)	43	47
Total, serious adverse events	Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction	1	65
Total, serious adverse events	Bortezomib Maintenance (VM)	0	47

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction vs Bortezomib Maintenance (VM): 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.

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/NCT00376961

GET https://conductscience.org/api/trials/v1/NCT00376961/results?page=2

API reference For AI assistants