Download PDF

Clinical Trial Results:
Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.

Summary
EudraCT number	2006-007083-28
Trial protocol	NL
Global end of trial date	11 Jul 2019

Results information
Results version number	v1(current)
This version publication date	26 Jan 2023
First version publication date	26 Jan 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

HOVON85NHL

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Other trial identifiers

Dutch Cochrane Centre: NTR1380

Sponsor organisation name

HOVON

Sponsor organisation address

De Boelelaan 1117, Amsterdam, Netherlands,

Public contact

HOVON Data Center, HOVON, +31 107041560, hdc@erasmusmc.nl

Scientific contact

HOVON Data Center, HOVON, +31 107041560, hdc@erasmusmc.nl

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

04 Nov 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

25 Oct 2016

Global end of trial reached?

Yes

Global end of trial date

11 Jul 2019

Was the trial ended prematurely?

Main objective of the trial

To assess the feasibility and efficacy of 90Y-ibritumomab tiuxetan consolidation treatment after R-PECC chemotherapy as second or third line treatment in patients with refractory or relapsed aggressive B-cell NHL, after or not eligible for autologous stem cell transplantation. Primary objective: ♦ Assessment of the feasibility of this treatment approach. Measured primarily by the percentage of patients that reach CR or PR after R-PECC and proceed to 90Y-ibritumomab tiuxetan treatment, and by the fraction of patients that endure the 90Y-ibritumomab tiuxetan treatment without major problems, i.e. the safety and tolerability of 90Y-ibritumomab tiuxetan after R-PECC chemotherapy.

Protection of trial subjects

Monitoring and insurance.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Aug 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Netherlands: 64

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Experimental Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Rituximab

Investigational medicinal product code

Other name

Mabthera

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

375 mg/m2 (max 750mg), day 1 or at day 0, cycle 1-4

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

40mg/m2, days 1-5, cycle 1-4

Investigational medicinal product name

Chlorambucil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

8mg/m2, days 1-5, cycle 1-4

Investigational medicinal product name

Etoposide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

100mg.m2, days 1-5, cycle 1-4

Investigational medicinal product name

Lomustine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

80mg/m2, day 1, cycle 1-4

Investigational medicinal product name

90Y-ibritumomab tiuxetan

Investigational medicinal product code

Other name

Zevalin

Pharmaceutical forms

Kit for radiopharmaceutical preparation

Routes of administration

Intravenous use

Dosage and administration details

14.8 MBq/kg, single dose in consolidation

Number of subjects in period 1	Experimental Group
Started	64
Completed	29
Not completed	35
Other	17
Lack of efficacy	18

Baseline characteristics

Top of page

Reporting group title

Overall trial

Reporting group description

Reporting group values	Overall trial	Total
Number of subjects	64	64
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	14	14
From 65-84 years	50	50
85 years and over	0	0
Age continuous
Units: years
median (full range (min-max))	70 (45 to 82)	-
Gender categorical
Units: Subjects
Female	21	21
Male	43	43

End points

Top of page

Reporting group title

Experimental Group

Reporting group description

Primary: Primary Endpoint

Top of page

End point title

Primary Endpoint ^[1]

End point description

End point type

Primary

End point timeframe

See publication.

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: See attached chart/documents for results.

End point values	Experimental Group
Number of subjects analysed	62
Units: Whole	62

Attachments

Statistical data section from publication
List of reported SAE's
List of reported non-SAE's

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

All AEs of grade 2 or higher, with the exception of progression of disease, will be reported from the first study-related procedure until 30 days following the last dose of study drug or until the start of subsequent systemic therapy, if earlier.

Adverse event reporting additional description

Resolution information after 30 days should also be provided. Adverse events occurring after 30 days should also be reported if considered related to study drug.

Assessment type

Systematic

Dictionary name

CTCAE

Dictionary version

Reporting group title

Experimental Group

Reporting group description

Serious adverse events	Experimental Group
Total subjects affected by serious adverse events
subjects affected / exposed	24 / 62 (38.71%)
number of deaths (all causes)	53
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	1 / 62 (1.61%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac disorders
Cardiac disorders
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	2 / 62 (3.23%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Nervous system disorders
Nervous system disorders
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	2 / 62 (3.23%)
occurrences causally related to treatment / all	2 / 2
deaths causally related to treatment / all	0 / 0
Blood and lymphatic system disorders
Blood and lymphatic disorders
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	8 / 62 (12.90%)
occurrences causally related to treatment / all	10 / 11
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
General disorders and administration site conditions
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	7 / 62 (11.29%)
occurrences causally related to treatment / all	3 / 7
deaths causally related to treatment / all	1 / 4
Gastrointestinal disorders
Gastrointestinal disorders
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	4 / 62 (6.45%)
occurrences causally related to treatment / all	1 / 4
deaths causally related to treatment / all	0 / 0
Reproductive system and breast disorders
Reproductive system and breast disorders
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	1 / 62 (1.61%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	2 / 62 (3.23%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	1 / 62 (1.61%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Infections and infestations
Additional description: All combined, see SAE chart for details.
subjects affected / exposed	7 / 62 (11.29%)
occurrences causally related to treatment / all	6 / 9
deaths causally related to treatment / all	2 / 2

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Experimental Group
Total subjects affected by non serious adverse events
subjects affected / exposed	50 / 62 (80.65%)
Vascular disorders
Vascular
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	1 / 62 (1.61%)
occurrences all number	1
General disorders and administration site conditions
Coagulation
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	1 / 62 (1.61%)
occurrences all number	1
Constitutional symptoms
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	21 / 62 (33.87%)
occurrences all number	28
Pain
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	10 / 62 (16.13%)
occurrences all number	13
Immune system disorders
Allergy/immunology
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	2 / 62 (3.23%)
occurrences all number	2
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	10 / 62 (16.13%)
occurrences all number	12
Cardiac disorders
Cardiac arrythmia
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	3 / 62 (4.84%)
occurrences all number	3
Cardiac general
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	4 / 62 (6.45%)
occurrences all number	5
Nervous system disorders
Neurology
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	6 / 62 (9.68%)
occurrences all number	7
Blood and lymphatic system disorders
Blood/bone marrow
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	34 / 62 (54.84%)
occurrences all number	198
Hemorrhage/bleeding
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	4 / 62 (6.45%)
occurrences all number	4
Lymphatics
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	2 / 62 (3.23%)
occurrences all number	3
Eye disorders
Ocular/visual
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	2 / 62 (3.23%)
occurrences all number	3
Gastrointestinal disorders
Gastrointestinal
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	15 / 62 (24.19%)
occurrences all number	23
Skin and subcutaneous tissue disorders
Dermatology/skin
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	9 / 62 (14.52%)
occurrences all number	12
Renal and urinary disorders
Renal/genitourinary
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	3 / 62 (4.84%)
occurrences all number	4
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	3 / 62 (4.84%)
occurrences all number	5
Infections and infestations
Infection
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	12 / 62 (19.35%)
occurrences all number	16
Metabolism and nutrition disorders
Metabolic/laboratory
Additional description: All combined, see non-SAE chart for details.
subjects affected / exposed	9 / 62 (14.52%)
occurrences all number	24

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

25 Apr 2012

Lay-out and administrative changes Change of PET review address Change of supplier Zevalin FU duration specified conform HOVON guidelines Update of safety paragraph to current guidelines Revision appendix B to avoid contradiction with paragraph 11 Revision and update appendix H due to change of supplier

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Primary Endpoint

Primary: Primary Endpoint

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Primary Endpoint

Primary: Primary Endpoint

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.