Trial · NCT00310037

Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

NCT00310037, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2018-07-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma. Trials, record NCT00310037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00310037

On this page

Trial

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

Title: Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
NCT number: NCT00310037
Status: Completed
Phases: Phase 2
Enrollment: 151 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Mantle Cell Lymphoma
Interventions: bortezomib
First posted: 2006-04-03
Last updated: 2025-10-28
Results first posted: 2018-07-31

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 18 Months	At 18 months	Progression free survival (PFS) rate at 18 months was defined as the proportion of patients that were alive and progression-free 18 months after registration into the study. The Kaplan-Meier method of 18 month progression-free survival was calculated..
Secondary	Overall Survival	Up to 10 years	Overall Survival (OS) was measured from the date of study entry to date of death due to any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Secondary	Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib	Up to 10 years	Complete response is: * Complete disappearance of all detectable clinical and radiographic evidence of target lesions and disappearance of all disease-related symptoms if present prior to therapy and normalization of biochemical abnormalities definitely assignable to NHL * All lymph nodes and nodal masses must have regressed to normal size (\<= 1.5 cm in the greatest transverse diameter (GTD) for nodes \> 1.5 cm prior to therapy) or \<= 1 cm for nodes that were 1.1-1.5 cm in the GTD prior to therapy or by more than 75% in the sum of the products of the GTD * The spleen, if enlarged before therapy, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging studies should no longer be present. Other organs enlarged prior to therapy due to involvement of lymphoma must have decreased in size * If bone marrow was involved by lymphoma prior to treatment, infiltrate must be cleared on repeat bone marrow aspirate
Secondary	Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.	Duration of treatment (up to approximately 2 years)	The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.

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 18 Months	At 18 months	percentage of participants	NUMBER
SECONDARY	Overall Survival	Up to 10 years	years	MEDIAN
SECONDARY	Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib	Up to 10 years	participants	NUMBER
SECONDARY	Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.	Duration of treatment (up to approximately 2 years)	participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Progression-free Survival Rate at 18 Months	Arm A Maintenance Therapy	88.5	95% Confidence Interval 80.2 to 97.6	percentage of participants
Progression-free Survival Rate at 18 Months	Arm B Consolidation Therapy	96	95% Confidence Interval 90.7 to 100	percentage of participants
Overall Survival	Arm A Maintenance Therapy	NA	95% Confidence Interval NA to NA	years
Overall Survival	Arm B Consolidation Therapy	8.9	95% Confidence Interval 7.2 to NA	years
Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib	Arm A Maintenance Therapy	31		participants
Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib	Arm B Consolidation Therapy	35		participants
Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.	Arm A Maintenance Therapy	52		participants
Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.	Arm B Consolidation Therapy	50		participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A Maintenance Therapy	52
Overall Study	STARTED	Arm B Consolidation Therapy	50
Overall Study	COMPLETED	Arm A Maintenance Therapy	34
Overall Study	COMPLETED	Arm B Consolidation Therapy	33
Overall Study	NOT COMPLETED	Arm A Maintenance Therapy	18
Overall Study	NOT COMPLETED	Arm B Consolidation Therapy	17

Source ClinicalTrials.gov

Adverse events772

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	Febrile neutropenia	Blood and lymphatic system disorders	Arm A Maintenance Therapy	32	52	46
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm B Consolidation Therapy	27	50	43
other	Hemoglobin decreased	Blood and lymphatic system disorders	Arm A Maintenance Therapy	38	52	357
other	Hemoglobin decreased	Blood and lymphatic system disorders	Arm B Consolidation Therapy	44	50	307
other	Hemolysis	Blood and lymphatic system disorders	Arm A Maintenance Therapy	3	52	3
other	Hemolysis	Blood and lymphatic system disorders	Arm B Consolidation Therapy	3	50	7
other	Lymph node pain	Blood and lymphatic system disorders	Arm A Maintenance Therapy	0	52	0
other	Lymph node pain	Blood and lymphatic system disorders	Arm B Consolidation Therapy	3	50	3
other	Lymphatic disorder	Blood and lymphatic system disorders	Arm A Maintenance Therapy	0	52	0
other	Lymphatic disorder	Blood and lymphatic system disorders	Arm B Consolidation Therapy	1	50	1

1 to 10 of 772Source ClinicalTrials.gov

See all 772 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A Maintenance Therapy
Total, all-cause mortality	Arm B Consolidation Therapy
Total, other adverse events	Arm A Maintenance Therapy	52	52
Total, other adverse events	Arm B Consolidation Therapy	50	50
Total, serious adverse events	Arm A Maintenance Therapy	13	52
Total, serious adverse events	Arm B Consolidation Therapy	10	50

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Arm A Maintenance Therapy vs Arm B Consolidation Therapy: Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.	Trial comparisons
Arm A Maintenance Therapy vs Arm B Consolidation Therapy: Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib	Trial comparisons
Arm A Maintenance Therapy vs Arm B Consolidation Therapy: 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/NCT00310037

GET https://conductscience.org/api/trials/v1/NCT00310037/events?page=2

API reference For AI assistants