Trial · NCT00711828
Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
NCT00711828, Phase 2, Completed, Mayo Clinic; results first posted 2015-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma. Trials, record NCT00711828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00711828
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
- NCT number
- NCT00711828
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Nodal Marginal Zone Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
- Interventions
- Bortezomib, Rituximab, Cyclophosphamide, Dexamethasone, Questionnaire Administration, Quality-of-Life Assessment
- First posted
- 2008-07-09
- Last updated
- 2019-04-16
- Results first posted
- 2015-01-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Responses (Complete Response or Partial Response) | up to 12 cycles | A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution. |
| Secondary | Overall Survival | Up to 3 years from registration | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. |
| Secondary | Progression-free Survival | Up to 3 years from registration | Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier. |
| Secondary | Duration of Response | Up to 3 years from registration | Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed. |
| Secondary | Time to Treatment Failure | Up to 3 years from registration | Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier. |
| Secondary | Adverse Events | up to 12 cycles (28 days per cycle) of treatment | Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report. |
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 | Proportion of Responses (Complete Response or Partial Response) | up to 12 cycles | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | Up to 3 years from registration | months | MEDIAN | |
| SECONDARY | Progression-free Survival | Up to 3 years from registration | months | MEDIAN | |
| SECONDARY | Duration of Response | Up to 3 years from registration | Thirteen patients achieved a CR or a PR and are included in this analysis. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | Up to 3 years from registration | months | MEDIAN | |
| SECONDARY | Adverse Events | up to 12 cycles (28 days per cycle) of treatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Responses (Complete Response or Partial Response) | Treatment | Complete Response (CR) | 19.0 | 95% Confidence Interval 5.5 to 41.9 | percentage of participants |
| Proportion of Responses (Complete Response or Partial Response) | Treatment | Partial Response (PR) | 42.9 | 95% Confidence Interval 21.8 to 66.0 | percentage of participants |
| Overall Survival | Treatment | 54.8 | 95% Confidence Interval 24.6 to 54.8 | months | |
| Progression-free Survival | Treatment | 11.6 | 95% Confidence Interval 3.8 to NA | months | |
| Duration of Response | Treatment | 25.9 | 95% Confidence Interval 8 to NA | months | |
| Time to Treatment Failure | Treatment | 6.6 | 95% Confidence Interval 2 to 11.6 | months | |
| Adverse Events | Treatment | Grade 3 | 19 | participants | |
| Adverse Events | Treatment | Grade 4 | 8 | participants | |
| Adverse Events | Treatment | Grade 5 | 0 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 21 | |
| Overall Study | COMPLETED | Treatment | 21 | |
| Overall Study | NOT COMPLETED | Treatment | 0 |
Source ClinicalTrials.gov
Adverse events46
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Treatment | 18 | 21 | 105 |
| other | Cardiac pain | Cardiac disorders | Treatment | 1 | 21 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment | 2 | 21 | 2 |
| other | Constipation | Gastrointestinal disorders | Treatment | 3 | 21 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Treatment | 8 | 21 | 15 |
| other | Gastritis | Gastrointestinal disorders | Treatment | 1 | 21 | 5 |
| other | Nausea | Gastrointestinal disorders | Treatment | 3 | 21 | 3 |
| other | Vomiting | Gastrointestinal disorders | Treatment | 1 | 21 | 1 |
| other | Fatigue | General disorders | Treatment | 20 | 21 | 111 |
| other | Fever | General disorders | Treatment | 1 | 21 | 1 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | ||
| Total, other adverse events | Treatment | 21 | 21 |
| Total, serious adverse events | Treatment | 7 | 21 |
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT00711828
GET https://conductscience.org/api/trials/v1/NCT00711828/events?page=2