Clinical Trial Results:
A Phase II Trial of Idelalisib in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma.
Summary
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EudraCT number |
2016-001058-16 |
Trial protocol |
SE DK |
Global end of trial date |
30 Sep 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Oct 2021
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First version publication date |
28 Oct 2021
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Other versions |
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 |
NLG-LBC-07
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03576443 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Skåne University Hospital
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Sponsor organisation address |
Gettingevägen 4, Lund, Sweden, 221 85
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Public contact |
Karin Fjordén, Skåne University Hospital, Department of Oncology, +46 4617 75 20, karin.fjorden@med.lu.se
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Scientific contact |
Karin Fjordén, Skåne University Hospital, Department of Oncology, +46 4617 75 20, karin.fjorden@med.lu.se
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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 |
04 Dec 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Dec 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Sep 2021
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy of idelalisib in patients with relapsed/refractory diffuse large B-cell lymphoma.
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Protection of trial subjects |
The responsible investigator will ensure that this study is conducted in agreement with the declaration of Helsinki, Fortaleza, Brazil, October 2013 and the laws and the regulations of the country. The protocol has been written, and the study will be conducted according to the guidelines for Good Clinical Practice, issued by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). As a pre-requirement for implementation, the protocol will have to be approved by the local, regional or national Ethical Review Boards according to the existing national and local regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Jul 2017
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Long term follow-up planned |
No
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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 |
Sweden: 27
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Country: Number of subjects enrolled |
Denmark: 9
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Worldwide total number of subjects |
36
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EEA total number of subjects |
36
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
4
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From 65 to 84 years |
29
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85 years and over |
3
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Recruitment
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Recruitment details |
First patient enrolled 07-Jul-2017 Last patient enrolled 22-Apr-2020 | ||||||||||||
Pre-assignment
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Screening details |
2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) , including transformed low grade lymphoma, with either: a. Refractory disease b. Persistent disease | ||||||||||||
Period 1
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Period 1 title |
Overall Trial (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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Overall Trial | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
idelalisib
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Investigational medicinal product code |
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Other name |
Zydelig
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
150 mg BID p.o. until progression
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- |
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End point title |
Overall response rate [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
Response was evaluated at weeks 8, 16, 24 and every 12 weeks thereafter, until 108 weeks after start of therapy
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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: This is a single arm study. Please refer to the published study |
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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 |
All AEs will be recorded from the time the subject signs informed consent to 28 days after the last dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
The trial was terminated prematurely afterrecruiting half of the originally planned number of patients due to futility in reaching the primary end-point | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/34435356 |