Trial · NCT00784927
Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
NCT00784927, Phase 2, Completed, Mayo Clinic; results first posted 2016-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma. Trials, record NCT00784927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784927
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
- NCT number
- NCT00784927
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Lymphoma
- Interventions
- rituximab, cyclophosphamide, dexamethasone, lenalidomide
- First posted
- 2008-11-04
- Last updated
- 2016-10-07
- Results first posted
- 2016-02-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Tumor Response | Up to 1 year from registration. | The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients. Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed. |
| Secondary | Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia). | Up to 1 year from registration. | The proportion of responses in Waldenstrom's macroglobulinemia was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients. Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed. |
| Secondary | Survival Time | Up to 1 year 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 Time | Up to 1 year from registration. | Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. Progressive disease is defined as having one of the following: * The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. * At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes. * At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. |
| Secondary | Time to Treatment Failure | Up to 1 year 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. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assessment of Tumor Response | Up to 1 year from registration. | percentage of participants | NUMBER | |
| SECONDARY | Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia). | Up to 1 year from registration. | percentage of participants | NUMBER | |
| SECONDARY | Survival Time | Up to 1 year from registration. | months | MEDIAN | |
| SECONDARY | Progression-free Survival Time | Up to 1 year from registration. | months | MEDIAN | |
| SECONDARY | Time to Treatment Failure | Up to 1 year from registration. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessment of Tumor Response | Treatment | Complete Response (CR) | 30.3 | 95% Confidence Interval 15.6 to 48.7 | percentage of participants |
| Assessment of Tumor Response | Treatment | Partial Response (PR) | 54.5 | 95% Confidence Interval 36.4 to 71.9 | percentage of participants |
| Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia). | Treatment | Complete Response (CR) | 6.7 | 95% Confidence Interval 0.2 to 32 | percentage of participants |
| Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia). | Treatment | Partial Response (PR) | 66.7 | 95% Confidence Interval 38.4 to 88.2 | percentage of participants |
| Survival Time | Treatment | NA | 95% Confidence Interval NA to NA | months | |
| Progression-free Survival Time | Treatment | 38.3 | 95% Confidence Interval 25.2 to NA | months | |
| Time to Treatment Failure | Treatment | NA | 95% Confidence Interval NA to NA | months |
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 | 36 | |
| Overall Study | COMPLETED | Treatment | 33 | |
| Overall Study | NOT COMPLETED | Treatment | 3 |
Source ClinicalTrials.gov
Adverse events69
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 | 28 | 33 | 174 |
| other | Sinus tachycardia | Cardiac disorders | Treatment | 1 | 33 | 1 |
| other | Vision blurred | Eye disorders | Treatment | 1 | 33 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment | 1 | 33 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment | 9 | 33 | 22 |
| other | Dyspepsia | Gastrointestinal disorders | Treatment | 1 | 33 | 1 |
| other | Esophagitis | Gastrointestinal disorders | Treatment | 1 | 33 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment | 12 | 33 | 31 |
| other | Oesophagoscopy abnormal | Gastrointestinal disorders | Treatment | 1 | 33 | 1 |
| other | Vomiting | Gastrointestinal disorders | Treatment | 4 | 33 | 6 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 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 | 33 | 33 |
| Total, serious adverse events | Treatment | 15 | 33 |
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/NCT00784927
GET https://conductscience.org/api/trials/v1/NCT00784927/events?page=2