Vaccination therapy for patients with untreated chronic lymphocytic leukemia

Phase 1

• Conditions: Chronic lymphocytic leukemia with un-mutated IGHV; MedDRA version: 20.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004869-14-DK
• Lead Sponsor: Dept. of hematology, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-07
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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 < 1% per year during the treatment period and for at least 120 days after the last treatment.
For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
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.