Clinical trial · Interventional
Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma
NCT01768338CI-TRIAL-00063854completedPhase 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)
The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ofatumumab combined with SB-485232 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ofatumumab combined with SB-485232
- description
- Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
- interventionNames
- Drug: Ofatumumab combined with SB-485232
Primary outcomes (1)
- measure
- To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
- timeFrame
- 8 weeks
- description
- Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).
Secondary outcomes (1)
- measure
- To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+ lymphoma. * Patients must be between 2-6 months post-transplantation at the time of study registration. * Patients must have at least stable disease (no overt progressive disease) at the time of study registration. * Laboratory values must be within protocol specified ranges. * Females of childbearing potential must have a negative pregnancy test. * Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy. Exclusion Criteria: * Patient must not have obvious clinical progression of lymphoma after PBSCT as determined by the treating physician. * Cannot be positive for hepatitis B surface antigen, hepatitis B core antibody or HIV antibody. * No major or uncontrolled comorbid conditions as determined by the treating physician: history of ventricular arrhythmias requiring drug or device therapy; uncontrolled angina or symptomatic congestive heart failure; • severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection; severe or uncontrolled psychiatric illness. * No known leptomeningeal involvement by lymphoma or current metastatic brain disease. * No Corrected QTc interval \> 480 msec. * No known or suspected hypersensitivity to ofatumumab or SB-485232 that in the opinion of the investigator is a contraindication to their participation in the study. * No systemic (oral or parenteral) corticosteroids within 14 days of study entry. * Not receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy. * No previous treatment with SB-485232 or ofatumumab. * No history of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. * No diabetes mellitus with poor glycemic control (documented hemoglobin A1c \>7% within 4 weeks prior to study entry).
References
Publications (0)
Data not yet available
No reference posted for this study.