Trial · NCT01644253
Phase 1b Safety and Efficacy Study of TRU-016
NCT01644253, Phase 1, Terminated, Aptevo Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1b Safety and Efficacy Study of TRU-016. Trials, record NCT01644253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01644253
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1b Safety and Efficacy Study of TRU-016
- NCT number
- NCT01644253
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 87 participants, actual
- Lead sponsor
- Aptevo Therapeutics
- Conditions
- Chronic Lymphocytic Leukemia, Peripheral T-cell Lymphoma
- Interventions
20 mg/kg TRU-016 + Rituximab, 10 mg/kg TRU-016 + Rituximab, TRU-016 20 mg/kg + Obinutuzumab, TRU-016 6-20 mg/kg + idelalisib + rituximab, TRU-016 10-20 mg/kg + ibrutinib, TRU-016 10-20 mg/kg + bendamustine
- First posted
- 2012-07-19
- Last updated
- 2021-05-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of adverse events | any time point during the study up to 18 months | |
| Primary | CLL Cysteine 481 mutation status | CLL patients in Cohort 7 will be followed for 9 months unless no cysteine 481 mutation is detected. | The primary endpoint for Cohort 7 is the elimination of the cysteine 481 mutant clone (\<1%). |
| Secondary | Overall Response Rate (ORR) | any time point during the study up to 18 months | |
| Secondary | Progression-free survival (PFS) | any time point during the study up to 18 months | |
| Secondary | Overall survival (OS) | any time point during the study up to 18 months | |
| Secondary | Duration of response (DOR) | any time point during the study up to 18 months | |
| Secondary | Resolution of disease-related symptoms | any time point during the study up to 18 months | Resolution of disease-related symptoms which are common to the disease include fever, weight loss, night sweats, fatigue, loss of appetite pain, and pruritus; symptoms will be assessed by descriptive statistics and data listings. |
| Secondary | Maximum serum drug concentration (Cmax) | any time point during the study up to 12 months | |
| Secondary | Minimum serum drug concentration (Cmin) | any time point during the study up to 12 months | |
| Secondary | Area under the concentration-time curve (AUC0-t and AUC0-∞) | any time point during the study up to 12 months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01644253
GET https://conductscience.org/api/trials/v1/NCT01644253/registered