Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Transgene
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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.
Clareo Health | Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma
