Phase 1b Safety and Efficacy Study of TRU-016

Conditions

• Chronic Lymphocytic Leukemia
• Peripheral T-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 20 mg/kg TRU-016 + Rituximab — BIOLOGICAL
  TRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses
• 10 mg/kg TRU-016 + Rituximab — BIOLOGICAL
  TRU-016: 6 mg/kg for first dose, all subsequent doses 10 mg/kg, IV on Day 1, 8 and 15, followed by 5 monthly doses Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV following TRU-016 schedule
• TRU-016 20 mg/kg + Obinutuzumab — BIOLOGICAL
  TRU-016: 6 mg/kg on Day 1, 20 mg/kg on Day 8 and 15, then 20 mg/kg once a month for 5 months Obinutuzumab: 100 mg on Day 1, 900 mg on Day 2, 1,000 mg on Day 8 and 15, then 1,000 mg once a month for 5 months
• TRU-016 6-20 mg/kg + idelalisib + rituximab — BIOLOGICAL
  TRU-016: 6 mg/kg on Days 15-36 weekly, 10 mg/kg on Days 43 and 50, then 20 mg/kg once a month for 5 months.
• TRU-016 10-20 mg/kg + ibrutinib — BIOLOGICAL
  TRU-016: Dosed weekly for 8 weeks followed by 4 monthly intravenous (IV) infusions. The first dose will be 10 mg/kg and all subsequent doses will be 20 mg/kg.
• TRU-016 10-20 mg/kg + bendamustine — BIOLOGICAL
  TRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days). Bendamustine (90 mg/m2 on days 2 and 3 of cycle 1 and then days 1 and 2 of cycles 2 to 6) will be infused after completion of TRU-016. If a patient is benefiting with stable disease or better, then TRU-016 may continue to be dosed every 3 weeks after the first 6 cycles; bendamustine will not be dosed beyond 6 cycles.

Study Details

The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.

Key Dates

Start date

Sep 30, 2012

Status verified

May 2021

Primary completion

Feb 24, 2020

Completion

Apr 21, 2021

Study Design

Enrollment

87 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 - Previously Untreated CLL
  20 mg/kg TRU-016 + Rituximab
• Experimental: Cohort 2 - Relapsed CLL
  20 mg/kg TRU-016 + Rituximab
• Experimental: Cohort 3 - Previously Untreated CLL
  10 mg/kg TRU-016 + Rituximab
• Experimental: Cohort 4 - Previously Untreated CLL
  20 mg/kg TRU-016 20 + Obinutuzumab
• Experimental: Cohort 5 - Relapse CLL
  20 mg/kg TRU-016 + idelalisib + rituximab
• Experimental: Cohort 6 - With CLL on ibrutinib with no complete response
  20 mg/kg TRU-016 + ibrutinib
• Experimental: Cohort 7 - With CLL on ibrutinib with stable disease
  20 mg/kg TRU-016 + ibrutinib
• Experimental: Cohort 8 - With relapsed or refractory PTCL
  20 mg/kg TRU-016 + 90 mg/m2 bendamustine

Primary Outcome Measure

Incidence and severity of adverse events [ Time Frame: any time point during the study up to 18 months ]

Locations (8)

Find similar trials in Augusta, GA

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