Trial · NCT01317901
A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
NCT01317901, Phase 1, Completed, Aptevo Therapeutics; results first posted 2016-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma. Trials, record NCT01317901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01317901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
- NCT number
- NCT01317901
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- Aptevo Therapeutics
- Conditions
- B-cell Small Lymphocytic Lymphoma Recurrent
- Interventions
- TRU-016, Bendamustine, Rituximab
- First posted
- 2011-03-17
- Last updated
- 2017-06-28
- Results first posted
- 2016-10-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response | Day 15 and Day 28 of even-numbered cycles | Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response | Day 15 and Day 28 of even-numbered cycles | All treated subjects | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response | TRU-016 (10 mg/kg) + Bendamustine + Rituximab | Complete Response | 3 | participants | |
| Response | 20 mg/kg of TRU 016 + Bendamustine + Rituximab | Complete Response | 2 | participants | |
| Response | TRU-016 (10 mg/kg) + Bendamustine + Rituximab | Partial Response | 1 | participants | |
| Response | 20 mg/kg of TRU 016 + Bendamustine + Rituximab | Partial Response | 4 | participants | |
| Response | TRU-016 (10 mg/kg) + Bendamustine + Rituximab | Stable disease | 1 | participants | |
| Response | 20 mg/kg of TRU 016 + Bendamustine + Rituximab | Stable disease | 0 | participants | |
| Response | TRU-016 (10 mg/kg) + Bendamustine + Rituximab | Relapsed/progressive disease | 1 | participants | |
| Response | 20 mg/kg of TRU 016 + Bendamustine + Rituximab | Relapsed/progressive disease | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mg/kg TRU-016+Bendamustine+Rituximab | 6 | |
| Overall Study | STARTED | 20 mg/kg TRU-016+Bendamustine+Rituximab | 6 | |
| Overall Study | COMPLETED | 10 mg/kg TRU-016+Bendamustine+Rituximab | 6 | |
| Overall Study | COMPLETED | 20 mg/kg TRU-016+Bendamustine+Rituximab | 6 | |
| Overall Study | NOT COMPLETED | 10 mg/kg TRU-016+Bendamustine+Rituximab | 0 | |
| Overall Study | NOT COMPLETED | 20 mg/kg TRU-016+Bendamustine+Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events146
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 | neutropenia | Blood and lymphatic system disorders | TRU-016 (10 mg/kg) | 5 | 6 | |
| other | neutropenia | Blood and lymphatic system disorders | TRU-016 (20 mg/kg) | 2 | 6 | |
| other | anemia | Blood and lymphatic system disorders | TRU-016 (10 mg/kg) | 2 | 6 | |
| other | anemia | Blood and lymphatic system disorders | TRU-016 (20 mg/kg) | 1 | 6 | |
| other | thrombocytopenia | Blood and lymphatic system disorders | TRU-016 (10 mg/kg) | 3 | 6 | |
| other | thrombocytopenia | Blood and lymphatic system disorders | TRU-016 (20 mg/kg) | 3 | 6 | |
| other | lymphopenia | Blood and lymphatic system disorders | TRU-016 (10 mg/kg) | 1 | 6 | |
| other | lymphopenia | Blood and lymphatic system disorders | TRU-016 (20 mg/kg) | 1 | 6 | |
| other | febrile neutropenia | Blood and lymphatic system disorders | TRU-016 (10 mg/kg) | 1 | 6 | |
| other | febrile neutropenia | Blood and lymphatic system disorders | TRU-016 (20 mg/kg) | 1 | 6 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRU-016 (10 mg/kg) | ||
| Total, all-cause mortality | TRU-016 (20 mg/kg) | ||
| Total, other adverse events | TRU-016 (10 mg/kg) | 6 | 6 |
| Total, other adverse events | TRU-016 (20 mg/kg) | 6 | 6 |
| Total, serious adverse events | TRU-016 (10 mg/kg) | 2 | 6 |
| Total, serious adverse events | TRU-016 (20 mg/kg) | 3 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24927856 | BACKGROUND |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| TRU-016 (10 mg/kg) vs TRU-016 (20 mg/kg): serious adverse events |
Source 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.
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/NCT01317901
GET https://conductscience.org/api/trials/v1/NCT01317901/events?page=2