Lymphoma, B-Cell
Conditions
Keywords
Primary CBCL including (WHO/EORTC classification 2005), Primary cutaneous marginal zone B-cell lymphoma, Primary cutaneous follicle center B-cell lymphoma, Primary cutaneous diffuse large B-cell other than leg type, Histologically consistent with primary CBCL, Relapse or active disease
Brief summary
The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL. Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.
Interventions
GENETICAdenovirus Interferon gamma
intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.
Sponsors
Transgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients must satisfy all the following criteria for entry into the protocol: Primary CBCL including (according to WHO/EORTC classification 2005) : * Primary cutaneous marginal zone B-cell lymphoma * Primary cutaneous follicle center B-cell lymphoma * Primary cutaneous diffuse large B-cell other than leg type * Histologically consistent with primary CBCL. * Relapse or active disease after radiotherapy or other adequate therapy if radiotherapy was contra-indicated (chemotherapy, surgical excision, interferonα, rituximab). * Performance status of 0, 1 on the Eastern Cooperative Oncology Group (ECOG) scale (See Appendix E). * Minimum Life Expectancy \> 3 months. * Adequate blood count: hemoglobin \>= 10.0 g/dL; White Blood Count (WBC) \>= 3.0 x 109/L; and platelet count \>= 75 x 109/L. * Adequate hepatic function: bilirubin =\< 1.5 times the upper limit of normal and serum transaminase (SGOT and SGPT)=\< 2.5 times the upper limit of normal. * Adequate renal function: creatinine =\< 1.5 times the upper limit of normal. * Written informed consent from patient.
Exclusion criteria
Patients will be excluded from the study for any of the following reasons: * Primary cutaneous diffuse large B-cell lymphoma, leg type. * Primary cutaneous intravascular large B-cell lymphoma. * Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy). * No histologic documentation of CBCL. * History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections. * Serious uncontrolled, concomitant medical disorders. * Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing) * Major surgery in previous 4 weeks preceding the 1st injection. * Pregnancy at study entry or who become pregnant during the study or women who are breast feeding. * Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection. * Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection. * Patient previously included in this study. * Non compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regression and disappearance of lesions | end of cycle |
| Safety | visit |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life | visit |
Countries
France, Switzerland, United States
Outcome results
None listed