Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO)

Sponsor
German CLL Study Group
Study ID
NCT02689141
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bendamustine — DRUG
    Debulking: Cycles 1 - 2, d1 \& 2: 70 mg/m2 i.v.
  • Ofatumumab — DRUG
    Induction: Cycle 1: Day 1 300 mg i.v.; Day 8 1000 mg i.v.; Day 15 1000 mg i.v. Cycle 2-6: Day 1 1000 mg i.v. Maintenance: After the induction ofatumumab iv 1000 mg every three months will be continued. Cycle 1-8: Day 1 1000 mg i.v.
  • Ibrutinib — DRUG
    Induction: Cycle 2-6: d1-28: 420 mg p.o. Maintenance: After the induction ibrutinib p.o. 420 mg daily will be continued. Cycle 1-8: d1-84: 420 mg p.o.

Study Details

A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by ofatumumab and ibrutinib followed by ibrutinib and ofatumumab maintenance in CLL patients.

Key Dates

Start date
Feb 4, 2016
Status verified
Jun 2020
Primary completion
Jul 13, 2017
Completion
Feb 6, 2020

Study Design

Enrollment
66 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustine + Ofatumumab + Ibrutinib
    Bendamustine: 70mg/m² i.v. Ofatumumab: 1000 mg i.v. Ibrutinib: 420 mg po

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 84 days after first dose of last induction cycle ]

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