Trial · NCT01665768
Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
NCT01665768, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2018-12-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma. Trials, record NCT01665768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01665768
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
- NCT number
- NCT01665768
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- CD20+, B-cell Lymphomas, Mantle Cell Lymphoma, Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL), Transformed Lymphoma/DLBCL/PMBCL, Hodgkin's Disease, Gray Zone Lymphoma
- Interventions
- Everolimus, Rituximab
- First posted
- 2012-08-15
- Last updated
- 2021-10-26
- Results first posted
- 2018-12-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as Assessed by Avoidance of Grade 3-4 Adverse Events | Up to 3 years | Number of participants who did not experience at least one grade 3-4 adverse event by CTCAE 4.0. |
| Secondary | Event Free Survival (EFS) | 2.5 years | Percentage of participants alive without disease progression. As defined by Cheson criteria, disease progression is a new lesion or \>= 50% increase in the size of previously identified sites of disease. EFS was estimated using Kaplan-Meier survival analysis. |
| Secondary | Percentage Change in the Frequency of Circulating Cancer Cells | Baseline, 1 year, 2 years and 3 years | Percentage change in circulating cancer cells between baseline and each timepoint noted below. |
| Secondary | Percentage Change in Cancer Cells When mTOR Kinase Inhibition is Applied | 1 year, 2 years, and 3 years | Percentage change in cancer cells when mTOR inhibition is applied in the laboratory. Samples from participants will be evaluated at each timepoint noted below. |
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 | Safety as Assessed by Avoidance of Grade 3-4 Adverse Events | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Event Free Survival (EFS) | 2.5 years | percentage of participants | NUMBER | |
| SECONDARY | Percentage Change in the Frequency of Circulating Cancer Cells | Baseline, 1 year, 2 years and 3 years | Data was not collected. | ||
| SECONDARY | Percentage Change in Cancer Cells When mTOR Kinase Inhibition is Applied | 1 year, 2 years, and 3 years | Data was not collected. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety as Assessed by Avoidance of Grade 3-4 Adverse Events | Everolimus and Rituximab | 1 | Participants | ||
| Event Free Survival (EFS) | Everolimus and Rituximab | 58 | 95% Confidence Interval 45 to 76 | percentage of 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 | Everolimus and Rituximab | 49 | |
| Overall Study | COMPLETED | Everolimus and Rituximab | 26 | |
| Overall Study | NOT COMPLETED | Everolimus and Rituximab | 23 |
Source ClinicalTrials.gov
Adverse events29
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 | ALT increased | Investigations | Everolimus and Rituximab | 4 | 49 | 6 |
| other | Anemia | Investigations | Everolimus and Rituximab | 5 | 49 | 12 |
| other | Diarrhea | Gastrointestinal disorders | Everolimus and Rituximab | 3 | 49 | 3 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Everolimus and Rituximab | 3 | 49 | 3 |
| other | Fatigue | General disorders | Everolimus and Rituximab | 3 | 49 | 3 |
| other | Hyperglycemia | Investigations | Everolimus and Rituximab | 10 | 49 | 25 |
| other | Hypertriglyceridemia | Investigations | Everolimus and Rituximab | 10 | 49 | 17 |
| other | Insomnia | General disorders | Everolimus and Rituximab | 3 | 49 | 3 |
| other | Leukopenia | Investigations | Everolimus and Rituximab | 31 | 49 | 73 |
| other | Lymphopenia | Investigations | Everolimus and Rituximab | 6 | 49 | 15 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus and Rituximab | 0 | 49 |
| Total, other adverse events | Everolimus and Rituximab | 47 | 49 |
| Total, serious adverse events | Everolimus and Rituximab | 13 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29234922 | RESULT |
Source 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 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/NCT01665768
GET https://conductscience.org/api/trials/v1/NCT01665768/events?page=2