Clinical trial · Interventional
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
NCT00742144CI-TRIAL-00030418completedPhase 1ClinicalTrials.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)
This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.
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 |
|---|---|---|---|
| Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ofatumumab | Drug | Ofatumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ofatumumab
- description
- Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
- interventionNames
- Drug: ofatumumab
Primary outcomes (1)
- measure
- tolerability
- timeFrame
- eight weeks
Secondary outcomes (1)
- measure
- Adverse event,Clinical laboratory tests,Immunoglobulin,HAHA,Objective response rate,Duration of response,Progression free survival,CD5,19,20,CD23 positive cells,Complement (CH50),PK parameters,
- timeFrame
- nine months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Signed Informed Consent. * Histologically confirmed relapsed or refractory CD20 positive FL grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or CD5, CD19, CD20 and CD23 positive relapse or refractory CLL. * Subjects must have adequate blood, liver, and kidney function. * Subjects who passed the provided periods from the last anti-cancer treatments at screening * ECOG Performance Status of 0-2 * Life expectancy more than 24 weeks at screening EXCLUSION CRITERIA: * Current and past malignancy other than FL and CLL within 5 years prior to screening. * Known Richter's transformation * Previous autologous stem cell transplantation within 24 weeks prior to screening * Previous allogeneic stem cell transplantation * Known CNS involvement * History of significant cerebrovascular disease * Current cardiac disease requiring medical treatment * Chronic or ongoing active infectious disease requiring systemic treatment * Patients with pleural effusion or ascites detectable by physical examination * Positive serology test for any of HBsAg, anti-HBc or anti-HCV * Known HIV positive * Pregnant or lactating women * Women of childbearing potential and male patients not willing to use adequate contraception
References
Publications (1)
- BACKGROUNDOgura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Jewell RC, Katsura K, Hotta T. Phase I study of ofatumumab, a human anti-CD20 antibody, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. Jpn J Clin Oncol. 2013 May;43(5):466-75. doi: 10.1093/jjco/hyt022. Epub 2013 Feb 28. PMID 23456745