Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

GlaxoSmithKline29 enrolled

Overview

The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukaemia, Lymphocytic, Chronic

Interventions

OfatumumabDRUG

Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has responded to ofatumumab treatment (CR, nPR, PR) or has had SD at least up to and including visit number 14 (24 weeks after first infusion) in the Hx-CD20-406 trial. * Has disease progression after visit number 14 (24 weeks after first infusion) in the Hx CD20 406 trial. * Received at least eight ofatumumab infusions. * Has active CLL with an indication for treatment. * Has Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1 or 2. * Provides signed informed consent, following receipt of verbal and written information about the trial, before any trial related activity is carried out. * If previously treated in GEN416 (this trial), the patient must have achieved CR with subsequent disease progression 24 weeks or later after the first infusion in the GEN416 trial. Exclusion Criteria: * The disease has transformed to more aggressive B-cell malignancies (e.g. diffuse large B-cell lymphoma, Richter's syndrome or prolymphocytic leukemia). * Has a suspected treatment requiring malignancy other than CLL. * Has received treatment other than ofatumumab within two weeks prior to visit 2. * Has clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from visit 1, congestive heart failure (NYHA III IV), and arrhythmia requiring therapy, with the exception of clinically non-significant extra systoles or minor conduction abnormalities. * Has significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease. * Has a history of significant cerebrovascular disease. * Is known HIV positive. * Has positive serology for hepatitis B, defined as a positive test for HBsAg and/or positive tests for both anti-HBs and anti-HBc. * Has known or suspected hypersensitivity to components of the IMP. * Has received treatment with any non-marketed drug substance or experimental therapy other than ofatumumab within four weeks prior to visit 2. * Currently participates in any other interventional clinical trial other than Hx-CD20-406. * Known or suspected to not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychiatric disorder). * Is breast feeding (women only). * Has a positive pregnancy test at screening (women only). * Is not willing to use adequate contraception during the trial and one year after last dose of ofatumumab (women only). Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the US the use of double barrier method is considered adequate.

Locations (2)

GSK Investigational Site

Örebro, Sweden

GSK Investigational Site

Stockholm, Sweden

Outcomes

Primary Outcomes

Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines

Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits \>=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, \<30% lymphocytes (LC), no lymphoid nodule; PR: \>=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by \>=50% from baseline; SD: no CR, PR, or PD.

Time frame: Start of treatment (Week 0/Visit 2) until Week 52

Secondary Outcomes

Duration of Response

Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.

Time frame: From the time of the initial response until progression or death (average of 14.1 study months)

Progression-Free Survival (PFS)

PFS is defined as the time from randomization until progression (prog.)/death. Prog. events are defined by well-documented and verifiable data; other data are censored. If the par. had prog. between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no prog. at the end of the trial, treatment discontinuation for undocumented prog./toxicity/other reason, new anti-cancer treatment, and death/prog. after \>=2 missed visits in a row, the endpoint was censored. Clinical prog. is not considered as a prog. endpoint.

Time frame: Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)

Data from ClinicalTrials.gov

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