A phase III, open label, randomized, multicenter trial of ofatumumab maintenance treatment versus no further treatment in subjects with relapsed chronic lymphocytic leukemia (CLL) who have responded to induction therapy. - ND

Phase 1

• Conditions: Subjects who are in CR or PR after 1 or 2 treatments for relapsed CLL; MedDRA version: 12.1Level: LLTClassification code 10008959Term: Chronic lymphocytic leukaemia (in remission)

• Registration Number: EUCTR2009-012518-39-IT
• Lead Sponsor: GlaxoSmithKline Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-22
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines [Hallek, 2008] 2. CR or PR according to the revised 2008 NCI-WG CLL criteria, confirmed by CT scan, after 2nd/3rd line treatment 3. The anti-leukemic treatment before study entry should have been at least 4 months of monotherapy with alkylating agents and/or at least 4 consecutive cycles of polychemotherapy (e.g. CVP), fludarabine-containing chemotherapy or immunochemotherapy 4. ECOG Performance Status of 0-2 5. Signed written informed consent prior to performing any study-specific procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Primary or secondary fludarabine-refractory subjects, defined as treatment failureor disease progression within 6 months of last anti-leukemic therapy [Hallek, 2008] NOTE: Subjects refractory to rituximab therapy as last therapy are permitted 2.Prior maintenance therapy 3.Known transformation of CLL (e.g. Richter s transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL 4.Active Autoimmune Hemolytic Anemia (AIHA) requiring treatment except if in the opinion of the investigator and medical monitor it is thought not to affect the subject s safety, the conduct of the study or the interpretation of the data 5.Previous autologous or allogeneic stem cell transplantation 6.Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis B or C (Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded*.)7.Other past or current malignancy (exception basal cell carcinoma skin or in situ carcinoma cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator and medical monitor it is thought not to affect the subject s safety, the conduct of the study or the interpretation of the data 8.Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities except if in the opinion of the investigator and medical monitor it is thought not to affect the subject s safety, the conduct of the study or the interpretation of the data 9.History of significant cerebrovascular disease or event with symptoms or sequelae 10.Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical monitor contraindicates participation in this study 11.Glucocorticoid unless given in doses ≤100 mg/day hydrocortisone (or equivalent dose of other glucocorticoid) if for exacerbations other than CLL (e.g. asthma)12.Known HIV positive 13.Screening laboratory values: Platelets<50 x 109/L, Neutrophils<1.0 x 109/L, Creatinine > 1.5 ULN (unless normal creatinine clearance), Total bilirubin > 1.5 ULN (unless due to liver involvement of CLL), Alanine Aminotransferase (ALT) > 2.5 ULN (unless due to liver involvement of CLL), Alkaline phosphatase > 2.5 upper normal limit 14.Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation 15.Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other interventional clinical study Note: Participation in any other interventional clinical study after disease progression during post PD follow-up is permitted OR participation in any other interventional clinical study where the subject received ONLY standard approved CLL therapy is permitted. 16.Lactating women, wi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate progression free survival (PFS) of ofatumumab maintenance treatment versus no further treatment after remission induction in subjects with relapsed Chronic Lymphocytic Leukaemia (CLL).;Secondary Objective: Secondary objectives are to evaluate clinical benefit, safety, tolerability and health-related quality of life of subjects treated with ofatumumab versus no further treatment. An additional secondary objective is to evaluate the pharmacokinetics in CLL subjects on maintenance ofatumumab.;Primary end point(s): The primary endpoint is progression-free-survival (PFS) which is defined as the time from randomization to the date of disease progression or death due to any cause. The investigator assessment of response will be assessed according to the IWCLL updated NCI-WG CLL criteria [Hallek, 2008].