NCT04184232

Brief Summary

Treatment of recurrent bladder cancer with dendritic cells

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

December 1, 2019

Last Update Submit

January 20, 2021

Conditions

Bladder Cancer

Keywords

Bladder CancerDendritic cells

Outcome Measures

Primary Outcomes (1)

  • Efficacy evaluation

    1 year relapse free survival

    1 year

Study Arms (2)

Dendritic cells

EXPERIMENTAL

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

Biological: Dendritic cellsOther: Standard treatment according to the Clinical protocols

Control

ACTIVE COMPARATOR

Patients with the recurrent bladder cancer receiving standard treatment

Other: Standard treatment according to the Clinical protocols

Interventions

Dendritic cellsBIOLOGICAL

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

Dendritic cells
Standard treatment according to the Clinical protocolsOTHER

Standard treatment of bladder cancer according to the Clinical protocols

ControlDendritic cells

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Andrei Hancharou, Dr

    Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

    STUDY DIRECTOR

  • Alexander V Prokharau, Dr

    Head of the chair, Belarusian State Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2019

First Posted

December 3, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)