Lymphoma and chronic lymphocytic leukaemia
Conditions
Interventions
Trade Name: Sativex
Product Name: Sativex
Pharmaceutical Form: Oromucosal spray
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Unsymptomatic patients, 18-80 years old, with mantle cell lymphoma, chronic lymphocytic leukaemia, follicular lymphoma or other indolent lymphoma with peripheral lymphocytes above 5/nL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Pregnancy, breastfeeding, previous mental illness in the patient, family history of psychosis or clinical depression, ongoing or previous substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect on tumor leukocyte numbers in blood ;Secondary Objective: Effect on tumor leukocyte phenotypes in blood ;Primary end point(s): Absolute lymphocyte count in peripheral blood;Timepoint(s) of evaluation of this end point: 2h, 4h, 6h, 24h and a week after the dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In malignant and non-malignant lymphocytes: phenotypic changes, gene-expression changes, changes in expression of the cannabinoid-receptor, cytokines in blood;Timepoint(s) of evaluation of this end point: 2h, 4h, 6h, 24h and a week after the dose | — |
Countries
Sweden
Contacts
Public ContactKarolinska University Hospital
Karolinska University Hospital
Outcome results
None listed