NCT01310101

Ofatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Brno University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale of the study is to explore the safety and efficacy of ofatumumab in combination with dexamethasone (O-dex regimen) in patients with refractory/relapsed CLL. Moreover, the hypothesis is that this approach will be able to achieve at least the same response rates compared with R-dex regimens (historical controls; manuscript submitted to Leukemia), while maintaining lower toxicity profile.

Detailed description

This is an open-label, multi-center, non-randomized, phase II study to evaluate the safety and efficacy of ofatumumab added to dexamethasone in subjects with relapsed or refractory chronic lymphocytic leukemia. The treatment will be given for a minimum of 3 cycles, until the best response, or up to a maximum of 6 cycles. After completion of the treatment phase in all patients, survival and disease status assessments will be performed in 1 month post treatment, and then every 2 months for 3 years. The patient will be followed-up in the study for 3 years if there is no progression. Dose and schedule Cycle 1: Ofatumumab: 300 mg as an i.v. infusion on day 1 of the cycle Ofatumumab: 2000 mg as an i.v. infusion on days 8, 15, 22; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18; Cycles 2 to 6 (cycles every 28 days): Ofatumumab: 1000 mg i.v. infusion on day 1, 8, 15 and 22 of the cycle; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18. Response will be assessed according to the IWCLL guidelines. The investigator assessment of response and progression will be considered primary for all endpoints described in the study. Safety of the treatment will be evaluated by: adverse events, laboratory tests, vital signs, electrocardiogram and performance status. Study Endpoints Primary Endpoint: Overall response rate (CR, CRi, PR rates) Secondary Endpoints: Toxicity, tolerability, adverse events (these events will be assessed by investigator and by the independent reviewers at the key time-points) Overall survival Progression-free survival Time to response and duration of response Time to progression and time to next therapy Other/Exploratory Endpoints: Exploratory molecular genetic, immunophenotypic, cytogenetic and pharmacologic markers

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	ofatumumab plus dexamethasone	Dose and schedule Cycle 1: Ofatumumab: 300 mg as an i.v. infusion on day 1 of the cycle; Ofatumumab: 2000 mg as an i.v. infusion on days 8, 15, 22; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18 Cycles 2 to 6 (cycles every 28 days): Ofatumumab: 1000 mg i.v. infusion on day 1, 8, 15 and 22 of the cycle; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-03-08
• Last updated: 2015-02-03

Locations

4 sites across 1 country: Czechia