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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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15 August 2022 |
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Main ID: |
ISRCTN31090206 |
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Date of registration:
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24/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase I clinical trial of idiotypic DNA vaccination in patients with B-cell lymphoma
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Scientific title:
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Phase I clinical trial of idiotypic DNA vaccine administered as a complex with polyethylenimine to patients with B-cell lymphoma |
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Date of first enrolment:
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03/04/2014 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN31090206 |
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Study type:
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Interventional |
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Study design:
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Non-randomised study (Treatment)
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Phase:
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Phase I
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Countries of recruitment
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Belarus
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Contacts
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Name:
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Nadzeya
Piatrouskaya |
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Address:
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N.N. Alexandrov National Cancer Centre of Belarus
Lesnoy
223040
Minsk
Belarus |
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Telephone:
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+375 (17)2879505 |
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Email:
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savitri@tut.by |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Surface immunoglobulin G or M isotype expression on tumor cells
2. Presence of tumor tissue biopsy before any treatment
3. The physical status scale ESOG 0 - 2
4. Life expectancy at least 24 months
5. Age 18 to 75 years
6. Adequate renal, hepatic, and bone marrow function
7. Signed written informed consent
8. The patient's ability to carry out the instructions of the doctor-researcher and comply with the treatment plan
Exclusion criteria:
1. Pregnancy and lactation
2. The presence of multiple primary cancer
3. History of autoimmune diseases (except Hashimoto's thyroiditis)
4. Severe diseases, including proceeding with symptomatic, untreated inflammatory and infectious processes
5. Social, economic or geographic circumstances which impede proper compliance with treatment protocols and follow-up
6. Polysensitisation
7. Positive tests for human immunodeficiency virus (HIV), hepatitis B or C
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Follicular lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia, mantle cell lymphoma, nodal marginal zone B cell lymphoma, MALT lymphoma, lymphoplasmacytic lymphoma, diffuse large B-cell lymphoma
Cancer
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Intervention(s)
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After informed consent, patients underwent an excisional lymph node biopsy to confirm diagnosis and to provide the material for Id identification and cloning. Patients received standard therapy for their diagnosis (4-6 months), and then were not treated for 2 to 6 months for immune recovery. Once the vaccine has been prepared, the patient received one or two courses of three vaccinations monthly. One of two vaccine constructions (scFv-PVXCP or MIP3A-scFv) was used per patient. Patients receive that form of the vaccine (scFv-PVXCP or MIP3A-scFv) which was first obtained by genetic engineering, so it is a random choice. However, this is not true randomization. After the last (3rd) vaccination in the course, immune response is observed at three time points: 1 week, 1 month and 2 months. If the first course of vaccination is not followed by immune response, they may be assigned a second course of vaccination with another form of the vaccine. Minimal residual disease (MRD) monitoring and at least one Magnetic Resonance Tomography (MRT) examination are performed for half a year after the last vaccination.
One dose included 500 µg of plasmid DNA solution in 1-2 ml sterile DPBS buffer. Linear PEI 8 kDa was used to prepare complexes with plasmid DNA with a ratio of N (PEI) to P (DNA) of 10/1. The required amount of 10 µg/µl solution PEI stock solution was diluted with 5% glucose to an equal volume of DNA solution added to it and rapidly mixed by pipetting. Mixture was kept for 10 minutes at room temperature to form complexes and administrated by intramuscular injection into the gluteal muscle.
The total duration of treatment is: standard chemotherapy (4-6 months) + recovery (2-6 months) + vaccination (2 months) + follow up (2 m
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Primary Outcome(s)
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Safety and tolerability of vaccination; local and systemic adverse events are observed and symptoms are measured according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
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Secondary Outcome(s)
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Immunologic response to vaccination (anti-Id cellular and humoral immune response), measured using ELISPOT and ELISA at diagnosis (before treatment), before vaccination (after treatment), 1 week, 1 month and 2 months after the last vaccination
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Secondary ID(s)
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Protocol reg.# 20142755
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Source(s) of Monetary Support
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Ministry of Health of the Republic of Belarus (MH RB)
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Ethics review
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Status:
Approval date:
Contact:
National Cancer Centre of Belarus ethics committee, 17/03/2015, ref: 20142755
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2021 |
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URL:
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