Clinical Trial Results:
Efficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg)
90Y-ibritumomab tiuxetan ("Zevalin") in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission following first-line R-CHOP therapy. A Phase II clinical trial (HOVON 77)
Summary
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EudraCT number |
2005-003796-20 |
Trial protocol |
BE |
Global end of trial date |
12 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jan 2023
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First version publication date |
29 Jan 2023
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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 |
HOVON 77
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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 |
HOVON
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Sponsor organisation address |
De Boelelaan 1117, Amsterdam, Netherlands,
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Public contact |
HOVON Data Center, HOVON, hdc@erasmusmc.nl
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Scientific contact |
HOVON Data Center, HOVON, hdc@erasmusmc.nl
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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 |
31 Jan 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Jan 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Jan 2017
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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 |
The primary objective of this study is to evaluate the conversion rate from PET-positive to PET-negative residual masses after 90Y-ibritumomab tiuxetan treatment in patients with PET-positive partial remission following first-line R-CHOP chemotherapy.
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Protection of trial subjects |
Monitoring and Insurance
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 May 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Netherlands: 19
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Worldwide total number of subjects |
19
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EEA total number of subjects |
19
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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) |
1
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From 65 to 84 years |
17
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85 years and over |
1
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Recruitment
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Recruitment details |
- | ||||||||||
Pre-assignment
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Screening details |
All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria. | ||||||||||
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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Experimental Group | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Rituximab
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Investigational medicinal product code |
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Other name |
Mabthera
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
250mg/m2, day -7 and 0
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Investigational medicinal product name |
90Y-ibritumomab tiuxetan
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Investigational medicinal product code |
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Other name |
Zevalin
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Pharmaceutical forms |
Kit for radiopharmaceutical preparation
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Routes of administration |
Intravenous use
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Dosage and administration details |
14.8MBq/kg (max dose 1184 MBq or 31mCi), day 0.
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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 |
Experimental Group
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Reporting group description |
- |
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End point title |
Primary Endpoint [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
Primary endopoint is dan complete response on FDG-PET (i.e. PET-negative residual masses) at 3 and 6 months after radioimmunotherapy.
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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: No article has been published for this trial. |
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Attachments |
List of reported non-SAE's List of reported SAE's |
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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 |
AEs will be reported on the CRF. All adverse events of Grade 2 or higher, with the exception of progression of disease, occurring during the protocol treatment period will be reported.
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Adverse event reporting additional description |
Adverse events occurring after that period should also be reported if considered related to protocol treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
3
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Reporting groups
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Reporting group title |
Experimental Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
None reported |