Clinical trial · Interventional
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
NCT00811733CI-TRIAL-00027867completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenstrom Macroglobulinaemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ofatumumab | Biological | Ofatumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ofatumumab
- description
- Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.
- interventionNames
- Biological: Ofatumumab
Primary outcomes (2)
- 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
- description
- OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFurman 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. PMID 27914971