Clinical Trial Results:
Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults
Summary
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EudraCT number |
2013-003632-71 |
Trial protocol |
ES |
Global end of trial date |
03 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Nov 2021
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First version publication date |
03 Nov 2021
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Other versions |
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Summary report(s) |
Final report summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DEND/TIA
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Clínica Universidad de Navarra
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Sponsor organisation address |
Avda. Pío XII, 36, Pamplona, Spain, 31008
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Public contact |
UCEC, Clínica Universidad de Navarra, 34 948255 4001142, ucicec@unav.es
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Scientific contact |
UCEC, Clínica Universidad de Navarra, 34 948255 4001142, ucicec@unav.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Apr 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study is to evaluate the safety of the proposed treatment in terms of:
- Effects attributable to the generation and administration of dendritic cells
- Adverse effects during treatment
- Autoimmunity
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Protection of trial subjects |
- Clinical trial supervised by the CEIm of Navarra
- In accordance with the GCP guidelines
- Patient confidentiality will be safeguarded in accordance with current legislation
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Background therapy |
NA | ||
Evidence for comparator |
NA | ||
Actual start date of recruitment |
01 Jul 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy, Ethical reason | ||
Long term follow-up duration |
3 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 6
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Worldwide total number of subjects |
6
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EEA total number of subjects |
6
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
1
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Adolescents (12-17 years) |
2
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Adults (18-64 years) |
3
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The patients were selected in the Pediatric and Neurosurgery consultations of the Clínica Universidad de Navarra. Patients were recruited between 09-30-14 (first patient) and 10-30-17 (last patient). Screening failures were two patients with CNS tumors that turned out to be low grade, the exclusion criterion set by the trial. | ||||||
Pre-assignment
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Screening details |
NA | ||||||
Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Treatment | ||||||
Arm description |
The time of administration of the vaccines is different for each type of tumor. After surgery, treatment for advanced sarcomas includes cycles of chemotherapy every three weeks (x6) that are given concomitantly with vaccines. The administration of vaccines includes 4 vaccines every three weeks 4 vaccines every two months and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. For CNS tumors, after surgery, treatment consists of radiation therapy plus chemotherapy. Chemotherapy cycles will be given every 3 weeks (x5). The administration of the vaccines includes 4 vaccines every three weeks, 4 vaccines every two months, and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Dendritic cell-based
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Investigational medicinal product code |
09-033
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Other name |
AUTOLOGOUS DENDRITIC CELLS DERIVED FROM MONOCYTES CHARGED WITH AUTOLOGOUS TUMOR LISTING
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
The cells are administered in suspension, at doses between 5x106 and 10x106, of administration repeated intradermal or intranodal.
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
The time of administration of the vaccines is different for each type of tumor. After surgery, treatment for advanced sarcomas includes cycles of chemotherapy every three weeks (x6) that are given concomitantly with vaccines. The administration of vaccines includes 4 vaccines every three weeks 4 vaccines every two months and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. For CNS tumors, after surgery, treatment consists of radiation therapy plus chemotherapy. Chemotherapy cycles will be given every 3 weeks (x5). The administration of the vaccines includes 4 vaccines every three weeks, 4 vaccines every two months, and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. |
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End point title |
Safety [1] | ||||||
End point description |
percentage of AE and relationship with treatment
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End point type |
Primary
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End point timeframe |
4 years.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As indicated in the protocol: The main variable of the study is the evaluation of safety. A descriptive analysis of the adverse events observed during the study will be carried out, both in global frequency and per patient, as well as changes in cell populations. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
4 years
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
none | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Treatment
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Reporting group description |
The time of administration of the vaccines is different for each type of tumor. After surgery, treatment for advanced sarcomas includes cycles of chemotherapy every three weeks (x6) that are given concomitantly with vaccines. The administration of vaccines includes 4 vaccines every three weeks 4 vaccines every two months and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. For CNS tumors, after surgery, treatment consists of radiation therapy plus chemotherapy. Chemotherapy cycles will be given every 3 weeks (x5). The administration of the vaccines includes 4 vaccines every three weeks, 4 vaccines every two months, and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
NA |