Ofatumumab retreatment and maintenancetreatment in patients with C

Conditions: B-cell Chronic Lymphocytic Leukemia (CLL)
MedDRA version: 14.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2008-001507-39-CZ

Lead Sponsor: GlaxoSmithKline

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 29

Inclusion Criteria

1. 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.
2. Has disease progression after visit number 14 (24 weeks after first infusion) in the Hx-CD20-406 trial.
3. Received at least eight ofatumumab infusions.
4. Has active CLL with an indication for treatment.
5. Has Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1 or 2.
6. Provides signed informed consent, following receipt of verbal and written information about the trial, before any trial related activity is carried out.
7. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The disease has transformed to more aggressive B-cell malignancies (e.g. diffuse large B-cell lymphoma, Richter’s syndrome or prolymphocytic leukemia).
2. Has a suspected treatment requiring malignancyother than CLL.
3. Has received anti-CLL treatment other than ofatumumab within two weeks prior to visit 2.
4. Has clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from visit 1, congestive heart failure (NYHAIII IV), and arrhythmia requiring therapy, with the exception of clinically non-significant extra systoles or minor conduction abnormalities.
5. Has significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
6. Has a history of significant cerebrovascular disease.
7. Is known HIV positive.
8. Has positive serology for hepatitis B, defined as a positive test for HBsAg and/or positive test for anti-HBc, unless considered due to intravenous immunoglobulin administration and negative test for HBV DNA.
9. Has known or suspected hypersensitivity to components of the IMP.
10. Has received treatment with any non-marketed drug substance or experimental therapy other than ofatumumab within four weeks prior to visit 2.
11. Currently participates in any other interventional clinical trial other than Hx-CD20-406.
12. Known or suspected to not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychiatric disorder).
13. Is breastfeeding (women only).
14. Has a positive pregnancy test at screening (women only).
15. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the proportion of objective responders over 52 weeks to ofatumumab retreatment and maintenance treatment in patients with B-cell chronic lymphocytic leukemia (CLL)who progressed following response or stable disease after ofatumumab treatment in an ongoing clinical trial, Hx-CD20-406.;Secondary Objective: To investigate the efficacy and safety of ofatumumab retreatment and maintenance treatment in patients with CLL.;Primary end point(s): Proportion of objective responders, according to the 1996 National Cancer Institute Sponsored Working Group (NCI-WG) guidelines, measured over a 52-weeks period from start of retreatment.;Timepoint(s) of evaluation of this end point: 52-weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Duration of response.<br>2. Progression free survival.<br>3. Time to next CLL therapy.<br>4. Overall survival.<br>5. Reduction in tumor size.<br>6. Adverse events.<br>7. Major infections.<br>8. Infections requiring hospitalization or intravenous antibiotics.<br>9. Human anti-human antibodies.<br>10. Pharmacokinetic parameters; Cmax, Cmin.;Timepoint(s) of evaluation of this end point: Not applicable