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

Aptevo Therapeutics79 enrolled

Overview

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.

This study consisted of two parts. The initial dose escalation stage was a Phase 1b study evaluating the safety and tolerability of two doses of TRU-016 administered in combination with bendamustine to patients with relapsed chronic lymphocytic leukemia (CLL). In the randomized Phase 2 stage of the study, the efficacy and safety of the selected dose of 20 mg/kg TRU-016 combined with bendamustine was compared to bendamustine alone. The pharmacokinetics and pharmacodynamics of TRU-016 and the development of antibodies to TRU-016 were evaluated in both phases of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia (CLL)

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

BendamustineDRUG

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (25)

Outcomes

Primary Outcomes

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.

Time frame: 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

Response Per NCI Criteria

Overall response rate per National Cancer Institute (NCI) Working group criteria.

Time frame: 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

Data from ClinicalTrials.gov

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