Chronic lymphocytic leukemia with un-mutated IGHV MedDRA version: 20.0 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: PD-L1 Long1 and PDL2 Long201
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: PD-L1 long1 (9-28)
Current Sponsor code: PD-L1 long1
Other descr
Sponsors
Dept. of hematology, Herlev Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CLL according to national guidelines. Unmutated IGHV gene No prior CLL directed treatment Age = 18 ECOG performance status of 0 or 1 No life-threatening conditions Adequate hematologic and end-organ function Bone marrow function: Neutrophilocytes > 1,0 x 109/l; Platelets > 100 x 109/l Renal function: eGFR/1,73m^2 > 50 For fertile women: agreement to use contraceptive methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Other active malignant diseases requiring treatment. Significant medical condition per investigators judgement e.g. severe Astma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus. Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis Serious known allergies or earlier anaphylactic reactions. Known sensibility towards Montanide ISA-51 Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. Pregnant and breastfeeding women. Fertile women not using secure contraception with a failure rate less than < 1% Psychiatric disorders that according to the investigator could influence compliance. Treatment with other experimental drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the efficacy of the vaccine, in means of changes in the lymphocyte count and structural changes in lymph node and/or spleen size.;Secondary Objective: The secondary objective is to evaluate vaccine specific immune responses before and during the treatment and continue to follow the safety profile of the drug.;Primary end point(s): Responses to the vaccine according to IW-CLL response criteria;Timepoint(s) of evaluation of this end point: Disease assesment will be performed before and after treatment which ends after 23 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first treatment;Timepoint(s) of evaluation of this end point: Patients will be followed until they fulfill the treatment criteria according to IW-CLL guidelines or until this endpoint can no longer be obtained. | — |
Countries
Denmark
Contacts
Public ContactPrimary invetsigator
Dept. of hematology, Herlev Hospital
Outcome results
None listed