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CompletedNCT04184232Updated Jan 22, 2021

Treatment of Recurrent Bladder Cancer With Dendritic Cells

A Phase 2 interventional study of Dendritic cells and Standard treatment according to the Clinical protocols in Bladder Cancer, sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus. Completed at 1 site in Belarus. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2019, registered Dec 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
17
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
Male
01

Study summary

Treatment of recurrent bladder cancer with dendritic cells

02

Conditions studied

  • Bladder Cancer

Keywords

  • Bladder Cancer
  • Dendritic cells
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 17 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed diagnosis of pTa bladder cancer;
  • Patient who require repetitive transurethral resection;
  • Expression of muc-1/wt-1 by the tumor;
  • EGOC 0-3;

Exclusion criteria

Exclusion Criteria:

  • any medical condition which can be associated with the high risk for the patient;
  • pregnancy/lactation;
  • chronic infections, including hepatitis B/C, tuberculosis, HIV
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Dendritic cells

    Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells

    Biological: Dendritic cells · Other: Standard treatment according to the Clinical protocols

  • Active comparator
    Control

    Patients with the recurrent bladder cancer receiving standard treatment

    Other: Standard treatment according to the Clinical protocols

Interventions

  • BiologicalDendritic cells

    Autologous dendritic cells primed with muc-1/wt-1 peptides

  • OtherStandard treatment according to the Clinical protocols

    Standard treatment of bladder cancer according to the Clinical protocols

06

What researchers measure

Primary outcomes

  1. Efficacy evaluation

    1 year relapse free survival

    Time frame: 1 year

07

Study locations

1 site
  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Minsk, 220072, Belarus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04184232
Lead sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
Responsible party
Sponsor
First posted
Dec 3, 2019
Start date
Jul 1, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Jan 22, 2021

Study contacts

Andrei Hancharou, Dr
study director · Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Alexander V Prokharau, Dr
study director · Head of the chair, Belarusian State Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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