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Phase I clinical trial of idiotypic DNA vaccination in patients with B-cell lymphoma

Phase I clinical trial of idiotypic DNA vaccine administered as a complex with polyethylenimine to patients with B-cell lymphoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31090206
Enrollment
30
Registered
2016-11-24
Start date
2014-04-03
Completion date
Unknown
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 th

Sponsors

Ministry of Health of the Republic of Belarus (MH RB)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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

Countries

Belarus

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026