NCT01188681|CompletedPhase 1ResultsDMC

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

A Phase 1b/2 Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Bendamustine vs. Bendamustine Alone in Patients With Relapsed Chronic Lymphocytic Leukemia

Aptevo Therapeutics ClinicalTrials.gov

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1 other identifier

16201

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredAug 2010

StartedSep 2010

CompletionDec 2014

Brief Summary

The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to bendamustine alone in patients with relapsed CLL.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Sep 2010

Longer than P75 for phase_1

Geographic Reach

5 countries

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

August 20, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed

7 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

January 6, 2017

Completed

Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

4.3 years

First QC Date

August 20, 2010

Results QC Date

May 17, 2016

Last Update Submit

May 26, 2021

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

CLLTRU-016chronic lymphocytic leukemiarelapsed CLLbendamustine

Outcome Measures

Primary Outcomes (1)

Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
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.
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

Secondary Outcomes (1)

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

Study Arms (4)

Phase 1: 15 mg/kg TRU-016 + Bendamustine

EXPERIMENTAL

TRU-016 (15 mg/kg) and bendamustine (70 mg/m2), n = 6 patients

Drug: 15 mg/kg TRU-016 and bendamustine

Phase 1: 20 mg/kg TRU-016 + Bendamustine

EXPERIMENTAL

TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 6 patients

Drug: 20 mg/kg TRU-016 and bendamustine

Phase 2: TRU-016 and bendamustine

EXPERIMENTAL

TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 32 patients

Drug: TRU-016 and bendamustine

Phase 2: Bendamustine

ACTIVE COMPARATOR

Bendamustine (70 mg/m2), n = 33 patients

Drug: Bendamustine

Interventions

TRU-016 and bendamustineDRUG

TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Phase 2: TRU-016 and bendamustine

BendamustineDRUG

Bendamustine at 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Phase 2: Bendamustine

15 mg/kg TRU-016 and bendamustineDRUG

TRU-016 at 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Phase 1: 15 mg/kg TRU-016 + Bendamustine

20 mg/kg TRU-016 and bendamustineDRUG

TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Phase 1: 20 mg/kg TRU-016 + Bendamustine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of relapsed CLL with 1 to 3 prior treatments
Demonstrated active disease requiring treatment
No prior bendamustine treatment
Not refractory to fludarabine or other purines, either as a single agent or in combination
Age \>/=18 years; male or female
Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2
Creatinine clearance \> 40 mL/min
Absolute neutrophil count (ANC) \>/= 1,200/mm3
Platelets \>/= 75,000/mm3
Lymphocytes \>/= 5,000/mm3 in Phase 1b

You may not qualify if:

Treatment with rituximab or other B-cell depleting agent within 30 days or alemtuzumab within 12 weeks
Previous anticancer therapy within 30 days
Refractory to prior fludarabine or other purine analog therapy either as a single agent or in combination
Receipt of prior bendamustine or TRU-016
Receipt of an investigational therapy or major surgery within 30 days
Previous or concurrent additional malignancy (some exceptions apply)
Any significant concurrent medical diseases or conditions
Positive serology for HIV or hepatitis C, hepatitis B surface antigen positive or hepatitis B core antibody positive.
Pregnant or breast feeding
Drug or alcohol abuse
Allergic to mannitol

Contact the study team to confirm eligibility.