Clinical Trial Results:
Etude prospective multicentrique de phase II évaluant l’adjonction du rituximab et du DepoCyte® en intrathécal au protocole de chimiothérapie C5R chez les patients âgés de 18 à 60 ans porteurs de lymphomes non hodgkiniens cérébraux primitifs et de lymphomes systémiques diffus à grandes cellules B avec envahissement neuro-méningé au diagnostic.

Trial information Top of page
Trial identification
Sponsor protocol code	R-C5R 2006
Additional study identifiers
ISRCTN number	-
US NCT number	NCT00553943
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	LYSA
Sponsor organisation address	CHU LYON SUD, PIERRE BENITE, France,
Public contact	PROJECT MANAGEMENT, LYSARC, affaires-reglementaires@lysarc.org
Scientific contact	COORDINATING INVESTIGATOR, LYSA, herve.ghesquieres@chu-lyon.fr
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	16 Mar 2017
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	16 Mar 2017
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	To measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy: -before cerebral radiotherapy for PCL -after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement
Protection of trial subjects	Standard care
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	31 Aug 2007
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Belgium: 12
Country: Number of subjects enrolled	France: 48
Worldwide total number of subjects	60
EEA total number of subjects	60
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	29
From 65 to 84 years	31
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	clinical examination (weight, BSA, pulse, blood pressure, Temp, physical examination, ECOG PS, Biochemical test, blood celle count), inclusion/exclusion criteria
Period 1
Period 1 title	Induction (overall period)
Is this the baseline period?	Yes
Allocation method	Not applicable
Blinding used	Not blinded
Arms
Arm title	Brain Lymphoma
Arm description	-
Arm type	Experimental
Investigational medicinal product name	cytarabine
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for infusion
Routes of administration	Intrathecal use
Dosage and administration details	2 cycles of R-COPADEM, followed by 2 cycles of R-CYM Cytarabine : 50 mg on D3 of each cycle
Number of subjects in period 1 Brain Lymphoma Started 60 Completed 53 Not completed 7      No treatment received 1      Protocol deviation 6

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Brain Lymphoma
Reporting group description	-

End points Top of page

Primary: Complete response rate Top of page
End point title	Complete response rate [1]
End point description
End point type	Primary
End point timeframe	End of chemotherapy
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: One arm = no comparative analysis
End point values Brain Lymphoma Number of subjects analysed 53 Units: percent     arithmetic mean (confidence interval 5%) 66 (53.3 to 78.8)
No statistical analyses for this end point

Primary: Complete response rate Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	From consent signature until one month after end of treatment or early discontinuation
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	16
Reporting groups
Reporting group title	Experimental
Reporting group description	-
Serious adverse events Experimental Total subjects affected by serious adverse events      subjects affected / exposed 31 / 54 (57.41%)      number of deaths (all causes) 16      number of deaths resulting from adverse events 5 Vascular disorders VASCULAR DISORDERS      subjects affected / exposed 3 / 54 (5.56%)      occurrences causally related to treatment / all 0 / 3      deaths causally related to treatment / all 0 / 0 Cardiac disorders CARDIAC DISORDERS      subjects affected / exposed 1 / 54 (1.85%)      occurrences causally related to treatment / all 1 / 1      deaths causally related to treatment / all 0 / 0 Nervous system disorders NERVOUS SYSTEM DISORDERS      subjects affected / exposed 3 / 54 (5.56%)      occurrences causally related to treatment / all 0 / 3      deaths causally related to treatment / all 0 / 0 Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS      subjects affected / exposed 3 / 54 (5.56%)      occurrences causally related to treatment / all 5 / 5      deaths causally related to treatment / all 1 / 1 General disorders and administration site conditions BLOOD AND LYMPHATIC SYSTEM DISORDERS      subjects affected / exposed 3 / 54 (5.56%)      occurrences causally related to treatment / all 2 / 3      deaths causally related to treatment / all 0 / 0 Gastrointestinal disorders GASTROINTESTINAL DISORDERS      subjects affected / exposed 1 / 54 (1.85%)      occurrences causally related to treatment / all 1 / 1      deaths causally related to treatment / all 0 / 0 Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS      subjects affected / exposed 1 / 54 (1.85%)      occurrences causally related to treatment / all 1 / 1      deaths causally related to treatment / all 0 / 0 Psychiatric disorders PSYCHIATRIC DISORDERS      subjects affected / exposed 3 / 54 (5.56%)      occurrences causally related to treatment / all 1 / 3      deaths causally related to treatment / all 0 / 0 Renal and urinary disorders RENAL AND URINARY DISORDERS      subjects affected / exposed 4 / 54 (7.41%)      occurrences causally related to treatment / all 3 / 4      deaths causally related to treatment / all 1 / 1 Infections and infestations INFECTIONS AND INFESTATIONS      subjects affected / exposed 25 / 54 (46.30%)      occurrences causally related to treatment / all 28 / 36      deaths causally related to treatment / all 3 / 3 Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS      subjects affected / exposed 2 / 54 (3.70%)      occurrences causally related to treatment / all 1 / 2      deaths causally related to treatment / all 0 / 0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events Experimental Total subjects affected by non serious adverse events      subjects affected / exposed 53 / 54 (98.15%) Vascular disorders VASCULAR DISORDERS      subjects affected / exposed 3 / 54 (5.56%)      occurrences all number 3 General disorders and administration site conditions GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS      subjects affected / exposed 11 / 54 (20.37%)      occurrences all number 16 Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS      subjects affected / exposed 2 / 54 (3.70%)      occurrences all number 2 Psychiatric disorders PSYCHIATRIC DISORDERS      subjects affected / exposed 4 / 54 (7.41%)      occurrences all number 4 Investigations INVESTIGATIONS      subjects affected / exposed 7 / 54 (12.96%)      occurrences all number 8 Cardiac disorders CARDIAC DISORDERS      subjects affected / exposed 1 / 54 (1.85%)      occurrences all number 1 Nervous system disorders NERVOUS SYSTEM DISORDERS      subjects affected / exposed 6 / 54 (11.11%)      occurrences all number 6 Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS      subjects affected / exposed 52 / 54 (96.30%)      occurrences all number 400 Gastrointestinal disorders GASTROINTESTINAL DISORDERS      subjects affected / exposed 7 / 54 (12.96%)      occurrences all number 7 Hepatobiliary disorders HEPATOBILIARY DISORDERS      subjects affected / exposed 3 / 54 (5.56%)      occurrences all number 4 Renal and urinary disorders RENAL AND URINARY DISORDERS      subjects affected / exposed 6 / 54 (11.11%)      occurrences all number 6 Infections and infestations INFECTIONS AND INFESTATIONS      subjects affected / exposed 38 / 54 (70.37%)      occurrences all number 68 Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS      subjects affected / exposed 6 / 54 (11.11%)      occurrences all number 9

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
12 Jan 2011	Stop of Arm 2 due to lack of enrollment
Interruptions (globally)
Were there any global interruptions to the trial? Yes
Date Interruption Restart date 12 Jan 2011 Stop of Arm 2 due to lack of enrollment -
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

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