Trial · NCT00436618
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
NCT00436618, Phase 2, Completed, Mayo Clinic; results first posted 2013-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment. Trials, record NCT00436618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00436618
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
- NCT number
- NCT00436618
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 277 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Leukemia, Lymphoma, Lymphoproliferative Disorder
- Interventions
- Everolimus
- First posted
- 2007-02-19
- Last updated
- 2019-10-22
- Results first posted
- 2013-07-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response. | 5 years | CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease. |
| Secondary | Overall Survival | 5 years | The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier. |
| Secondary | Progression-free Survival | 5 years | Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes. |
| Secondary | Time to Progression | 5 years | The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response. | 5 years | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | percentage of patients in group | NUMBER |
| SECONDARY | Overall Survival | 5 years | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | years | MEDIAN |
| SECONDARY | Progression-free Survival | 5 years | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | years | MEDIAN |
| SECONDARY | Time to Progression | 5 years | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | years | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response. | Relapsed Aggressive Non-Hodgkin Lymphoma | 26 | 95% Confidence Interval 19 to 35 | percentage of patients in group | |
Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response. | Relapsed Indolent Non-Hodgkin Lymphoma | 35 | 95% Confidence Interval 22 to 49 | percentage of patients in group | |
Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response. | Uncommon Lymphomas | 49 | 95% Confidence Interval 39 to 58 | percentage of patients in group | |
| Overall Survival | Relapsed Aggressive Non-Hodgkin Lymphoma | 0.66 | 95% Confidence Interval 0.44 to 0.99 | years | |
| Overall Survival | Relapsed Indolent Non-Hodgkin Lymphoma | 2.45 | 95% Confidence Interval 1.04 to 4.97 | years | |
| Overall Survival | Uncommon Lymphomas | 3.41 | 95% Confidence Interval 2.31 to 5.13 | years | |
| Progression-free Survival | Relapsed Aggressive Non-Hodgkin Lymphoma | 0.18 | 95% Confidence Interval 0.16 to 0.27 | years | |
| Progression-free Survival | Relapsed Indolent Non-Hodgkin Lymphoma | 0.60 | 95% Confidence Interval 0.41 to 1.03 | years | |
| Progression-free Survival | Uncommon Lymphomas | 0.79 | 95% Confidence Interval 0.52 to 1.09 | years | |
| Time to Progression | Relapsed Aggressive Non-Hodgkin Lymphoma | 0.18 | 95% Confidence Interval 0.16 to 0.29 | years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relapsed Aggressive Non-Hodgkin Lymphoma | 114 | |
| Overall Study | STARTED | Relapsed Indolent Non-Hodgkin Lymphoma | 55 | |
| Overall Study | STARTED | Uncommon Lymphomas | 107 | |
| Overall Study | COMPLETED | Relapsed Aggressive Non-Hodgkin Lymphoma | 84 | |
| Overall Study | COMPLETED | Relapsed Indolent Non-Hodgkin Lymphoma | 28 | |
| Overall Study | COMPLETED | Uncommon Lymphomas | 46 | |
| Overall Study | NOT COMPLETED | Relapsed Aggressive Non-Hodgkin Lymphoma | 30 | |
| Overall Study | NOT COMPLETED | Relapsed Indolent Non-Hodgkin Lymphoma | 27 | |
| Overall Study | NOT COMPLETED | Uncommon Lymphomas | 61 |
Source ClinicalTrials.gov
Adverse events621
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 | Relapsed Aggressive Non-Hodgkin Lymphoma | 0 | 114 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Relapsed Indolent Non-Hodgkin Lymphoma | 0 | 55 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Uncommon Lymphomas | 3 | 107 | 4 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Relapsed Aggressive Non-Hodgkin Lymphoma | 107 | 114 | 426 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Relapsed Indolent Non-Hodgkin Lymphoma | 49 | 55 | 207 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Uncommon Lymphomas | 103 | 107 | 770 |
| other | Atrial fibrillation | Cardiac disorders | Relapsed Aggressive Non-Hodgkin Lymphoma | 1 | 114 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Relapsed Indolent Non-Hodgkin Lymphoma | 0 | 55 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Uncommon Lymphomas | 1 | 107 | 1 |
| other | Cardiac disorder | Cardiac disorders | Relapsed Aggressive Non-Hodgkin Lymphoma | 1 | 114 | 1 |
1 to 10 of 621Source ClinicalTrials.gov
See all 621 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relapsed Aggressive Non-Hodgkin Lymphoma | ||
| Total, all-cause mortality | Relapsed Indolent Non-Hodgkin Lymphoma | ||
| Total, all-cause mortality | Uncommon Lymphomas | ||
| Total, other adverse events | Relapsed Aggressive Non-Hodgkin Lymphoma | 113 | 114 |
| Total, other adverse events | Relapsed Indolent Non-Hodgkin Lymphoma | 55 | 55 |
| Total, other adverse events | Uncommon Lymphomas | 107 | 107 |
| Total, serious adverse events | Relapsed Aggressive Non-Hodgkin Lymphoma | 38 | 114 |
| Total, serious adverse events | Relapsed Indolent Non-Hodgkin Lymphoma | 11 | 55 |
| Total, serious adverse events | Uncommon Lymphomas | 25 | 107 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT00436618
GET https://conductscience.org/api/trials/v1/NCT00436618/events?page=2