Clinical trial NCT00811733: A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Official title: A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Waldenstrom Macroglobulinaemia
Keywords: Waldenstrom's Macroglobulinemia
Ofatumumab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients with Waldenstrom's Macroglobulinemia (WM).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: 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
measure: 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
measure: 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
measure: Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator
timeFrame: From baseline up to approximately 5 years
measure: Progression-free Survival
timeFrame: From baseline up to approximately 5 years
measure: Time to Response for Responders
timeFrame: From baseline up to approximately 5 years
measure: Overall Survival
timeFrame: From baseline up to approximately 5 years
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result
timeFrame: From baseline up to approximately 5 years
measure: Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment
timeFrame: Baseline and Month 3
measure: Number of Participants With the Indicated SAEs Related to Study Drug
timeFrame: From baseline up to approximately 5 years
measure: Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug
timeFrame: From baseline up to approximately 5 years
measure: 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
measure: Number of Participants With the Indicated >=Grade 3 AEs
timeFrame: From baseline up to approximately 5 years
measure: Number of Participants With the Indicated Infusion-related >=Grade 3 AE
timeFrame: From baseline up to approximately 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Stanford
country: United States
facility: GSK Investigational Site
state: California
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenstrom's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. doi: 10.1016/S2352-3026(16)30166-1. Epub 2016 Dec 1.