Trial · NCT01188681

Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia

NCT01188681, Phase 1, Phase 2, Completed, Aptevo Therapeutics; results first posted 2017-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia. Trials, record NCT01188681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01188681

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
NCT number: NCT01188681
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 79 participants, actual
Lead sponsor: Aptevo Therapeutics
Conditions: Chronic Lymphocytic Leukemia (CLL)
Interventions: TRU-016 and bendamustine, Bendamustine, 15 mg/kg TRU-016 and bendamustine, 20 mg/kg TRU-016 and bendamustine
First posted: 2010-08-25
Last updated: 2021-06-10
Results first posted: 2017-01-06

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria	1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years	Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.
Secondary	Response Per NCI Criteria	1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years	Overall response rate per National Cancer Institute (NCI) Working group criteria.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria	1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years	Treated patients	percentage of patients	NUMBER
SECONDARY	Response Per NCI Criteria	1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years	Safety data for all patients who received any study drug and efficacy data for randomized patients who received some study treatment and have some post baseline data are presented here.	percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria	Phase 1 15 mg/kg TRU-016	66.7	percentage of patients
Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria	Phase 1 20 mg/kg TRU-016	83.3	percentage of patients
Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria	TRU-016 and Bendamustine	68.8	percentage of patients
Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria	Bendamustine	39.4	percentage of patients
Response Per NCI Criteria	Phase 2: TRU-016 and Bendamustine	81.3	percentage of patients
Response Per NCI Criteria	Phase 2: Bendamustine	66.7	percentage of patients
Response Per NCI Criteria	Phase 1: 15 mg/kg TRU-016 +Beendamustine	66.7	percentage of patients
Response Per NCI Criteria	Phase 1: 20 mg/kg TRU-016 +Bendamustine	100	percentage of patients

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 1 15 mg/kg	6
Overall Study	STARTED	Phase 1 20 mg/kg	6
Overall Study	STARTED	Phase 2 TRU-016 and Bendamustine	33
Overall Study	STARTED	Phase 2 Bendamustine	34
Overall Study	COMPLETED	Phase 1 15 mg/kg	6
Overall Study	COMPLETED	Phase 1 20 mg/kg	6
Overall Study	COMPLETED	Phase 2 TRU-016 and Bendamustine	32
Overall Study	COMPLETED	Phase 2 Bendamustine	33
Overall Study	NOT COMPLETED	Phase 1 15 mg/kg	0
Overall Study	NOT COMPLETED	Phase 1 20 mg/kg	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events268

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
other	Neutropenia	Blood and lymphatic system disorders	Phase 1: 15 mg/kg	5	6
other	Neutropenia	Blood and lymphatic system disorders	Phase 1: 20 mg/kg	4	6
other	Neutropenia	Blood and lymphatic system disorders	Phase 2: TRU-016 and Bendamustine	19	32
other	Neutropenia	Blood and lymphatic system disorders	Phase 2:Bendamustine	13	33
other	Anaemia	Blood and lymphatic system disorders	Phase 1: 15 mg/kg	3	6
other	Anaemia	Blood and lymphatic system disorders	Phase 1: 20 mg/kg	3	6
other	Anaemia	Blood and lymphatic system disorders	Phase 2: TRU-016 and Bendamustine	10	32
other	Anaemia	Blood and lymphatic system disorders	Phase 2:Bendamustine	11	33
other	Thrombocytopenia	Blood and lymphatic system disorders	Phase 1: 15 mg/kg	0	6
other	Thrombocytopenia	Blood and lymphatic system disorders	Phase 1: 20 mg/kg	1	6

1 to 10 of 268Source ClinicalTrials.gov

See all 268 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1: 15 mg/kg
Total, all-cause mortality	Phase 1: 20 mg/kg
Total, all-cause mortality	Phase 2: TRU-016 and Bendamustine
Total, all-cause mortality	Phase 2:Bendamustine
Total, other adverse events	Phase 1: 15 mg/kg	6	6
Total, other adverse events	Phase 1: 20 mg/kg	6	6
Total, other adverse events	Phase 2: TRU-016 and Bendamustine	24	32
Total, other adverse events	Phase 2:Bendamustine	25	33
Total, serious adverse events	Phase 1: 15 mg/kg	3	6
Total, serious adverse events	Phase 1: 20 mg/kg	1	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27977057	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01188681

GET https://conductscience.org/api/trials/v1/NCT01188681/events?page=2

API reference For AI assistants