Clinical trial · Interventional
CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas
Le23 CPG: A Phase 1-2 Study of Intratumoral Injection of CPG 7909, A TLR 9 Agonist, Combined With Local Radiation in Recurrent Low-Grade Lymphomas
NCT00185965CI-TRIAL-00015285completedPhase 1 / Phase 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)
Brief summary TBD
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPG 7909 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lymphoma, B-cell low-grade (BCL)
- description
- Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)
- interventionNames
- Drug: CPG 7909
- type
- EXPERIMENTAL
- label
- Mycosis fungoides (MF)
- description
- Mycosis fungoides patients must have failed or have been intolerant of at least 1 topical or 1 systemic treatment Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)
- interventionNames
- Drug: CPG 7909
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:Patients must meet all of the following criteria in order to be eligible for entry into the trial. * Biopsy confirmed low-grade B-cell lymphoma of any initial stage or mycosis fungoides of stage IB-IVA. B-cell lymphoma patients must have failed at least one prior treatment. Mycosis fungoides patients must have failed or have been intolerant of at least 2 topical or one systemic treatment. * Patients must have at least one site of disease that is accessible for intratumoral injection of CpG percutaneously * Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the treatment. * Patients must have measurable disease other than the injection site or biopsy site. * 18 years of age or older * Karnofsky Performance Status (KPS) of \> 70. * Adequate bone marrow function: WBC\>4,000uL, hemoglobin \> 10g/dL; platelet count \>100,000/mm3; ANC\> 1000. * Adequate hepatic function: bilirubin \<= 1.5 mg/dL; SGOT/SGPT\<3xupper limit of normal * Adequate renal function: serum creatinine \<= 2.0mg/dL. * Required wash out periods for prior therapy: * Topical therapy: 2 weeks * Chemotherapy: 4 weeks * Radiotherapy (including photo therapy): 4 weeks * Systemic biological therapy for mycosis fungoides: 4 weeks * Other investigational therapy: 4weeks * Rituximab: 12 weeks * Patients of reproductive potential and their partners must agree to use an effective (\>90% reliability) form of contraception during the study and for 4 weeks following the last study drug administration. * Women of reproductive potential must have negative urine pregnancy test. * Life expectancy greater than 4 months. * Able to comply with the treatment schedule. Exclusion Criteria:A patient may not be enrolled in the trial if any of the following criteria are met. * Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease. * Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active, prior treatment, or both). * Patients with active infection or with a fever \>38.50 C within three days prior to the first scheduled treatment. * CNS metastases * Prior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix. * History of allergic reactions attributed to compounds of similar composition to CpG 7909 * Current anticoagulant therapy (ASA\<= 325mg/day allowed). * Significant cardiovascular disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias). * Pregnant or lactating. * Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results.
References
Publications (2)
- RESULTKim YH, Gratzinger D, Harrison C, Brody JD, Czerwinski DK, Ai WZ, Morales A, Abdulla F, Xing L, Navi D, Tibshirani RJ, Advani RH, Lingala B, Shah S, Hoppe RT, Levy R. In situ vaccination against mycosis fungoides by intratumoral injection of a TLR9 agonist combined with radiation: a phase 1/2 study. Blood. 2012 Jan 12;119(2):355-63. doi: 10.1182/blood-2011-05-355222. Epub 2011 Nov 1. PMID 22045986
- RESULTBrody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, Kim YH, Hoppe RT, Knox SJ, Shin LK, Wapnir I, Tibshirani RJ, Levy R. In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: a phase I/II study. J Clin Oncol. 2010 Oct 1;28(28):4324-32. doi: 10.1200/JCO.2010.28.9793. Epub 2010 Aug 9. PMID 20697067