Trial · NCT00722137

Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT00722137, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2014-11-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma. Trials, record NCT00722137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00722137

On this page

Trial

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

Title: Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma
NCT number: NCT00722137
Status: Completed
Phases: Phase 3
Enrollment: 487 participants, actual
Lead sponsor: Millennium Pharmaceuticals, Inc.
Conditions: Mantle Cell Lymphoma
Interventions: Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, Prednisone 100 mg/m^2, Vincristine 1.4 mg/m^2
First posted: 2008-07-25
Last updated: 2018-07-12
Other registries' IDs: eudract:2007-005669-37
Results first posted: 2014-11-17

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS)	Median duration of follow-up of 40 months	PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.
Secondary	Time to Progression (TTP)	Median duration of follow-up of 40 months	Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.
Secondary	Duration of Response	Median duration of follow-up of 40 months	The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).
Secondary	Time to Next Anti-lymphoma Treatment (TTNT)	: Median duration of follow-up of 40 months	The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.
Secondary	Treatment-free Interval (TFI)	Median duration of follow-up of 40 months	The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.
Secondary	Overall Response Rate (ORR)	Median duration of follow-up of 40 months	ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.
Secondary	Overall Complete Response (CR + CRu)	Median duration of follow-up of 40 months	Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.
Secondary	Overall Survival (OS)	Median duration of follow-up of 40 months	OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.
Secondary	18-Month Survival	Up to month 18 from the time of randomization	18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).
Secondary	Overall Survival (OS) in Long Term Follow-up Period	Up to 107.4 months	OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS)	Median duration of follow-up of 40 months	The population consisted of all randomized participants.	Days	MEDIAN
SECONDARY	Time to Progression (TTP)	Median duration of follow-up of 40 months	The population consisted of all randomized participants.	Days	MEDIAN
SECONDARY	Duration of Response	Median duration of follow-up of 40 months	The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had \>= 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.	Days	MEDIAN
SECONDARY	Time to Next Anti-lymphoma Treatment (TTNT)	: Median duration of follow-up of 40 months	The population consisted of all randomized participants.	Days	MEDIAN
SECONDARY	Treatment-free Interval (TFI)	Median duration of follow-up of 40 months	All randomized participants who received at least 1 dose of study medication.	Days	MEDIAN
SECONDARY	Overall Response Rate (ORR)	Median duration of follow-up of 40 months	The response-evaluable population was defined as all participants who received \>= 1 dose of study drug, had at least 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.	Participants	NUMBER
SECONDARY	Overall Complete Response (CR + CRu)	Median duration of follow-up of 40 months	The response-evaluable population was defined as all participants who received \>= 1 dose of study drug, had at least 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.	Participants	NUMBER
SECONDARY	Overall Survival (OS)	Median duration of follow-up of 40 months	The population consisted of all randomized participants.	Days	MEDIAN
SECONDARY	18-Month Survival	Up to month 18 from the time of randomization	The population consisted of all randomized participants.	Percentage of Participants	MEAN
SECONDARY	Overall Survival (OS) in Long Term Follow-up Period	Up to 107.4 months	The population consisted of all randomized participants.	Days	MEDIAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group28

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

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival (PFS)	R-CHOP		437.0	95% Confidence Interval 365.0 to 513.0	Days
Progression Free Survival (PFS)	VcR-CAP		751.0	95% Confidence Interval 604.0 to 969.0	Days
Time to Progression (TTP)	R-CHOP		490.0	95% Confidence Interval 417.0 to 550.0	Days
Time to Progression (TTP)	VcR-CAP		929.0	95% Confidence Interval 696.0 to 1245.0	Days
Duration of Response	R-CHOP	Duration of response	459.0	95% Confidence Interval 379.0 to 518.0	Days
Duration of Response	VcR-CAP	Duration of response	1110.0	95% Confidence Interval 813.0 to 1320.0	Days
Duration of Response	R-CHOP	Duration for Complete responders	563.0	95% Confidence Interval 486.0 to 738.0	Days
Duration of Response	VcR-CAP	Duration for Complete responders	1282.0	95% Confidence Interval 933.0 to 1602.0	Days
Time to Next Anti-lymphoma Treatment (TTNT)	R-CHOP		756.0	95% Confidence Interval 674.0 to 837.0	Days
Time to Next Anti-lymphoma Treatment (TTNT)	VcR-CAP		1353.0	95% Confidence Interval 1180.0 to NA	Days

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	R-CHOP	244
Overall Study	STARTED	VcR-CAP	243
Overall Study	COMPLETED	R-CHOP	199
Overall Study	COMPLETED	VcR-CAP	195
Overall Study	NOT COMPLETED	R-CHOP	45
Overall Study	NOT COMPLETED	VcR-CAP	48

Source ClinicalTrials.gov

Adverse events316

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	Nausea	Gastrointestinal disorders	R-CHOP	33	242
other	Nausea	Gastrointestinal disorders	VcR-CAP	59	240
other	Abdominal distension	Gastrointestinal disorders	R-CHOP	5	242
other	Abdominal distension	Gastrointestinal disorders	VcR-CAP	22	240
other	Abdominal pain	Gastrointestinal disorders	R-CHOP	9	242
other	Abdominal pain	Gastrointestinal disorders	VcR-CAP	18	240
other	Abdominal pain upper	Gastrointestinal disorders	R-CHOP	11	242
other	Abdominal pain upper	Gastrointestinal disorders	VcR-CAP	16	240
other	Dyspepsia	Gastrointestinal disorders	R-CHOP	14	242
other	Dyspepsia	Gastrointestinal disorders	VcR-CAP	13	240

1 to 10 of 316Source ClinicalTrials.gov

See all 316 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	R-CHOP
Total, all-cause mortality	VcR-CAP
Total, other adverse events	R-CHOP	187	242
Total, other adverse events	VcR-CAP	185	240
Total, serious adverse events	R-CHOP	72	242
Total, serious adverse events	VcR-CAP	91	240

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25738670	DERIVED	PubMed
28183846	DERIVED	PubMed
28583031	DERIVED	PubMed
30348538	DERIVED	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 comparisons3

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

Comparison	Source
R-CHOP vs VcR-CAP: Number of Participants Experiencing an Adverse Event (AE)	Trial comparisons
R-CHOP vs VcR-CAP: Overall Response Rate (ORR)	Trial comparisons
R-CHOP vs VcR-CAP: 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/NCT00722137

GET https://conductscience.org/api/trials/v1/NCT00722137/results?page=2

API reference For AI assistants