Last updated: 11/07/2018 04:03:05
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Efficacy and safety of ofatumumab retreatment and maintenance treatment in patients with B-cell chronic lymphocytic leukemia (CLL)
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A single-arm, international, multi-center trial investigating the efficacy and safety of ofatumumab retreatment and maintenance in CLL patients who progressed following response or stable disease after ofatumumab treatment in Hx-CD20-406
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
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
Timeframe: Start of treatment (Week 0/Visit 2) until Week 52
Secondary outcomes:
Duration of response
Timeframe: From the time of the initial response until progression or death (average of 14.1 study months)
Progression-Free Survival (PFS)
Timeframe: Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)
Time to next chronic lymphocytic leukemia (CLL) treatment
Timeframe: Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)
Overall Survival (OS)
Timeframe: Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)
Median percent change of tumor size (sum of products dimensions [SPD]) from Baseline (Visit 2) at Month 4
Timeframe: Baseline (Visit 2) and Month 4
Median percent change of tumor size (sum of products dimensions [SPD]) from Baseline (Visit 2) at Month 12
Timeframe: Baseline (Visit 2) and Month 12
Median percent change of tumor size (sum of products dimensions [SPD]) from Baseline (Visit 2) at Month 24
Timeframe: Baseline (Visit 2) and Month 24
Number of participants with negative and positive human anti-human antibody (HAHA) results at the time of screening and post ofatumumab
Timeframe: Screening and post ofatumumab (up to Study Month 32)
Number of participants who experienced any adverse event
Timeframe: From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])
Number of participants with the indicated major infections
Timeframe: From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])
Number of participants with infections requiring hospitalization or intravenous antibiotics
Timeframe: From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])
Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4)
Timeframe: Visit 2 (Week 0) and Visit 14 (Month 4)
Interventions:
Enrollment:
29
Primary completion date:
2011-21-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Österborg A, Wierda WG, Mayer J, et al.Ofatumumab retreatment and maintenance in Fludarabine-Refractory Chronic Lymphocytic Leukemia Patients .Br J Haematol.2015;170(1):40-49
Medical condition
Leukaemia, Lymphocytic, Chronic
Product
ofatumumab
Collaborators
Genmab
Study date(s)
January 2009 to May 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2011-21-09
Actual study completion date
2013-20-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website