A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia
Trial overview
Number of participants with Overall Response (OR) for Cycle 1 (including the Redosing Cycle), as assessed by the Investigator
Timeframe: Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
Number of participants with OR for Cycle 1 (excluding the Redosing Cycle), as assessed by the Investigator
Timeframe: Baseline and up to Study Week 16
Number of participants with CR, PR, and MR for Cycle 1 (including the Redosing Cycle), as assessed by the Investigator
Timeframe: Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
Number of participants with CR, PR, and MR for Cycle 1 (excluding the Redosing Cycle), as assessed by the Investigator
Timeframe: Baseline and up to Study Week 16
Number of participants with IgM flare for Cycle 1 response (including the Redosing Cycle)
Timeframe: Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
Duration of Response for all responders (CR, PR, MR), as assessed by the Investigator
Timeframe: From baseline up to approximately 5 years
Progression-free survival
Timeframe: From baseline up to approximately 5 years
Time to response for responders
Timeframe: From baseline up to approximately 5 years
Overall survival
Timeframe: From baseline up to approximately 5 years
Clearance of ofatumumab
Timeframe: From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
Volume of distribution at steady state of ofatumumab
Timeframe: From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
Half-life of ofatumumab
Timeframe: From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
Cmax and Ctrough of ofatumumab
Timeframe: From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
AUC(0-tau) and AUC(0-inf) of ofatumumab
Timeframe: From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
Number of participants with at least one confirmed positive post-ofatumumab HAHA result
Timeframe: From baseline up to approximately 5 years
Change from Baseline in blood counts (CD4+, CD19+, CD50) at Month 3 after treatment
Timeframe: Baseline and Month 3
Number of participants with the indicated SAEs related to study drug
Timeframe: From baseline up to approximately 5 years
Number of participants with the indicated SAEs and non-serious AEs related to study drug
Timeframe: From baseline up to approximately 5 years
Number of participants with the indicated AEs leading to permanent discontinuation of study drug and withdrawal from study
Timeframe: From baseline up to approximately 5 years
Number of participants with the indicated >=Grade 3 AEs
Timeframe: From baseline up to approximately 5 years
Number of participants with the indicated infusion-related >=Grade 3 AE
Timeframe: From baseline up to approximately 5 years
Participation criteria
- Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.
- Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.
- Treatment of WM within the past 28 days.
- Treatment with rituximab or alemtuzamab within the past 3 months.
- Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.
- Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.
- Adequate organ function.
- Detectable CD20 positive of the tumor cells.
- Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL.
- Treatment of WM within the past 28 days.
- Treatment with rituximab or alemtuzamab within the past 3 months.
- Certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years.
- Current participation in another interventional clinical study.
- Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception.
- Active cerebrovascular disease.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.