Clinical trial · Interventional
Biological Therapy Plus Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Multi-Center, Phase I, Open Label, Two Arm, Non-Randomized, Dose-Escalation, Study Of The Safety And Tolerability Of CPG 7909 In Patients Receiving Rituxan For Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma
- 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)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Biological therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer cells from growing. Combining CpG 7909 with rituximab may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating patients who have relapsed or refractory 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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| agatolimod sodium | Drug | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma (NHL) * CD20 positive by immunohistochemistry or flow cytometry * Relapsed or refractory disease * Bidimensionally measurable disease * Sole site of measurable disease within a previously irradiated field allowed provided there was disease progression at that site * No pre-existing ascites or pleural effusions * No known CNS involvement by NHL PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * Neutrophil count at least 1,000/mm3 * Platelet count at least 50,000/mm3 Hepatic: * Bilirubin less than 2 mg/dL * Transaminase less than 2 times upper limit of normal * No hepatitis B or C Renal: * Creatinine less than 2 mg/dL Cardiovascular: * No significant cardiovascular disease * No New York Heart Association class III congestive heart failure * No myocardial infarction within the past 6 months * No unstable angina * No uncontrolled atrial or ventricular cardiac arrhythmias Pulmonary: * No concurrent significant pulmonary disease Other: * HIV negative * No acute infection requiring antibiotics * No fever over 38.2 degrees C within the past 3 days * No other malignancy within the past 5 years except basal cell or noninvasive squamous cell skin cancer or carcinoma in situ of the cervix * No pre-existing autoimmune disease or antibody-mediated disease, including: * Systemic lupus erythematosus * Rheumatoid arthritis * Multiple sclerosis * Sjogren's syndrome * Autoimmune thrombocytopenia * Controlled thyroid disease allowed * Concurrent autoantibodies without clinical autoimmune disease allowed * No history of allergic reactions attributed to compounds of similar composition to study drugs * No other medical history, including laboratory results, that would preclude study * No suspected or confirmed poor compliance or mental instability that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior allogeneic transplantation * More than 30 days since prior hematopoietic growth factors (e.g., filgrastim (G-CSF) or epoetin alfa) * More than 30 days since prior immunotherapy * More than 90 days since prior monoclonal antibodies as monotherapy for patients who were unresponsive to treatment (30 days for patients who responded to treatment and subsequently relapsed) * No other concurrent biological agents * No concurrent hematopoietic growth factors (e.g., G-CSF or epoetin alfa) Chemotherapy: * More than 30 days since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * More than 30 days since prior systemic corticosteroids * No concurrent systemic corticosteroids Radiotherapy: * See Disease Characteristics * More than 30 days since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * Recovered from prior therapy * At least 6 months since prior coronary angioplasty * More than 30 days since prior immunosuppressants * More than 30 days since prior participation in an investigational drug study * No concurrent immunosuppressants * No concurrent anticoagulants except aspirin at doses no greater than 325 mg/day * No other concurrent anticancer therapy * No other concurrent investigational agents
References
Publications (1)
- RESULTLeonard JP, Link BK, Emmanouilides C, Gregory SA, Weisdorf D, Andrey J, Hainsworth J, Sparano JA, Tsai DE, Horning S, Krieg AM, Weiner GJ. Phase I trial of toll-like receptor 9 agonist PF-3512676 with and following rituximab in patients with recurrent indolent and aggressive non Hodgkin's lymphoma. Clin Cancer Res. 2007 Oct 15;13(20):6168-74. doi: 10.1158/1078-0432.CCR-07-0815. PMID 17947483