Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO)
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|ClinicalTrials.gov Identifier: NCT02689141|
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Bendamustine Drug: Ofatumumab Drug: Ibrutinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 4, 2016|
|Actual Primary Completion Date :||July 13, 2017|
|Actual Study Completion Date :||February 6, 2020|
Experimental: Bendamustine + Ofatumumab + Ibrutinib
Bendamustine: 70mg/m² i.v. Ofatumumab: 1000 mg i.v. Ibrutinib: 420 mg po
Debulking: Cycles 1 - 2, d1 & 2: 70 mg/m2 i.v.
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.
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.
- Overall response rate (ORR) [ Time Frame: 84 days after first dose of last induction cycle ]Proportion of patients responding according to international working Group on chronic lymphocytic leukemia criteria
- Safety: Adverse events (AEs) and adverse events of special interest (AESI) [ Time Frame: up to 48 months after first dose of study drug ]Type, frequency, and severity of adverse events (AEs) and adverse events of special interest (AESI) and their relationship to study treatment.
- minimal residual disease (MRD) [ Time Frame: up to 48 months after first dose of study drug ]Rate of MRD responses in peripheral blood measured by immunophenotyping
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689141
|German CLL Study Group|
|Cologne, Germany, 50935|
|Principal Investigator:||Paula Cramer, Dr.med.||German CLL Study Group|