Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Prospective, Open-label, Multicentre Phase-II Trial to Evaluate Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by Ofatumumab and Ibrutinib Followed by Ibrutinib and Ofatumumab Maintenance in CLL Patients
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.
In the CLL2-BIO trial an allcomer CLL population with indication for treatment will be
included.
Patient will receive 2 cycles of debulking treatment with bendamustin unless
contraindications are existing or debulking is not indicated. Afterwards 6 cycles of
induction therapy with ofatumumab and ibrutinib will be applied, each with a duration of 28
days. Primary endpoint overall Response rate will be assessed at final restaging.
Patients benefitting from BIO treatment will enter the maintenance phase of the trial.
Maintenance treatment will be continued if no unacceptable toxicity occurs until three months
after negativity of minimal residual disease (MRD) is achieved in peripheral blood in
patients with (clinical) complete response (CR) or (clinical) incomplete complete response
(CRi) confirmed by 2 consecutive testings of MRD within 3 months, progression of CLL, start
of a subsequent therapy or up to 8 cycles of maintenance (each cycle with a duration of 84
calendar days = 3 months), whichever occurs first.
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