Phase 2
N=37
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Waldenstrom Macroglobulinaemia
Bottom Line
View on ClinicalTrials.gov: NCT00811733 ↗Enrolled (actual)
37
Serious AEs
32.4%
Results posted
Apr 2012
Primary outcome: Primary: Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator — 7; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ofatumumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator |
7; 15 | — |
| PRIMARY Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator |
5; 14 | — |
| SECONDARY Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator |
0; 0; 4; 11; 3; 4 | — |
| SECONDARY Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator |
0; 0; 3; 9; 2; 5 | — |
| SECONDARY Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle) |
7; 9; 8; 13; 1; 2 | — |
| SECONDARY Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator |
449.0; 455.0 | — |
| SECONDARY Progression-free Survival |
558.0; 536.0 | — |
| SECONDARY Time to Response for Responders |
78; 81 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Clearance of Ofatumumab |
27.9; 13.5 | — |
| SECONDARY Volume of Distribution at Steady State of Ofatumumab |
10.0; 10.7 | — |
| SECONDARY Half-life of Ofatumumab |
10.9; 23.9 | — |
| SECONDARY Cmax and Ctrough of Ofatumumab |
68.3; 72.1; NA; 465; 259; NA | — |
| SECONDARY AUC(0-tau) and AUC(0-inf) of Ofatumumab |
21419; NA; NA; 75526; 120886; NA | — |
| SECONDARY Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result |
1; 4 | — |
| SECONDARY Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment |
-35.5; 98; -26; -24.5; 9; -43 | — |
| SECONDARY Number of Participants With the Indicated SAEs Related to Study Drug |
0; 1; 0; 1; 1; 0 | — |
| SECONDARY Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug |
4; 8; 4; 9; 4; 3 | — |
| SECONDARY Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Drug and Withdrawal From Study |
1; 1; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With the Indicated >=Grade 3 AEs |
1; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With the Indicated Infusion-related >=Grade 3 AE |
1; 1; 1; 0; 0; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00811733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.