Flag of the European Union

EU Clinical Trials Register

Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).

The EU Clinical Trials Register currently displays 43865 clinical trials with a EudraCT protocol, of which 7286 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

Examples: Cancer AND drug name. Pneumonia AND sponsor name.
How to search [pdf]

Advanced Search:

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

< Back to search results

Clinical Trial Results:
RANDOMIZED PHASE III STUDY OF LENALIDOMIDE (REVLIMID®) MAINTENANCE IN RESPONDING ELDERLY PATIENTS WITH DLBCL AND TREATED WITH R-CHOP IN FIRST LINE

Summary
EudraCT number	2008-008202-52
Trial protocol	BE FR PT ES AT PL
Global end of trial date	30 Sep 2019

Results information
Results version number	v1(current)
This version publication date	10 Apr 2021
First version publication date	10 Apr 2021
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

REMARC

ISRCTN number

-

US NCT number

NCT01122472

WHO universal trial number (UTN)

-

Sponsor organisation name

LYSARC

Sponsor organisation address

Centre Hospitalier Lyon-Sud_Bat 2D, Pierre Bénite, France, 69495

Public contact

Anne Schuyleman, LYSARC, REMARC@lysarc.org

Scientific contact

Pr Catherine Thieblemont, APHP, catherine.thieblemont@aphp.fr

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

Analysis stage

Final

Date of interim/final analysis

30 Sep 2019

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

30 Sep 2019

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective is to determine the benefit estimated by the progression-free survival associated with lenalidomide maintenance compared to placebo in responding patients treated with R-CHOP for diffuse large B-cell lymphoma.

Protection of trial subjects

DSMC periodically reviewed the safety and efficacy data from the trial prepared by the independent statistician. All data presented at the meeting were confidential. Following each meeting the DSMC prepared a report and may recommended changes in trial conduct

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

14 May 2009

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 27

Country: Number of subjects enrolled

Portugal: 33

Country: Number of subjects enrolled

Spain: 52

Country: Number of subjects enrolled

Austria: 19

Country: Number of subjects enrolled

Belgium: 54

Country: Number of subjects enrolled

France: 403

Country: Number of subjects enrolled

Switzerland: 4

Country: Number of subjects enrolled

Israel: 9

Country: Number of subjects enrolled

Australia: 49

Worldwide total number of subjects

650

EEA total number of subjects

588

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)

177

From 65 to 84 years

473

85 years and over

0

Subject disposition

Top of page

Recruitment details

Recruitment period per country: - Australia: from 08MAR11 to 13MAY14 - Austria: from 01JUN11 to 19AUG13 - Belgium: from 27APR10 to 03MAR14 - France: 14MAY09 to 25MAR14 - Israel: 21DEC11 to 14JAN14 - Poland: 12SEP11 to 12FEB14 - Portugal: 15MAR10 to 18NOV13 - Spain: 17AUG10 to 01APR14 - Switzerland: 03JAN11 to 13MAR13

Screening details

Patients aged from 60 to 80 years (>59 year and <81 years old) at time of registration and responding (CR or PR) to 1st line treatment with R-CHOP for diffuse large B-cell Lymphoma, CD 20 positive

Period 1 title

overall trial (randomized patients) (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Lenalidomide

Arm description

Lenalidomide 25mg/ day 3 weeks every 4 weeks for 24 months

Arm type

Experimental

Investigational medicinal product name

Revlimid®

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Dosage: Starting dose 25mg lenalidomide (200 mg of excipient anhydrous lactose) Dose reduction: 20, 15, 10 or 5 mg of lenalidomide and respectively 244.5, 289, 294 or 147 mg of excipient anhydrous lactose. Administration: Lenalidomide administered daily from D1 to D21, repeated at day 29 for 24 months (max up to 26 cycles). Day 1 of cycle 1 of study drug treatment occured within 12 weeks (84 days) after the first day of the last R-CHOP cycle or the last Rituximab alone

Placebo

Arm description

Placebo 25mg/day 3 weeks every 4 weeks for 24 months

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Dosage: Starting dose: 25mg Placebo 25, 20, 15, 10 and 5 mg is presented in hard capsules. Two types of placebos may be used. - One placebo contains the excipients used for the drug product (matching placebo): Lactose Anhydrous Microcrystalline Cellulose Croscarmellose Sodium Magnesium Stearate. - The other placebo is a standardized formulation containing microcrystalline cellulose (standardized placebo). Capsules conform in colour and size for blinded studies Administration: Daily from D1 to D21, repeated at D29 for 24 months (max up to 26 cycles) Day 1 of cycle 1 occured within 12 weeks (84 days) after the first day of last R-CHOP cycle or the last Rituximab alone

Number of subjects in period 1	Lenalidomide	Placebo
Started	323	327
Completed	204	219
Not completed	119	108
Consent withdrawn by subject	11	4
Death	97	91
Lost to follow-up	11	13

Baseline characteristics

Top of page

Reporting group title

Lenalidomide

Reporting group description

Lenalidomide 25mg/ day 3 weeks every 4 weeks for 24 months

Reporting group title

Placebo

Reporting group description

Placebo 25mg/day 3 weeks every 4 weeks for 24 months

Reporting group values	Lenalidomide	Placebo	Total
Number of subjects	323	327	650
Age categorical
Units: Subjects
Adults (18-64 years)	81	96	177
From 65-84 years	242	231	473
Age continuous
Units: years
arithmetic mean (standard deviation)	69 ( 5.52 )	68.5 ( 5.58 )	-
Gender categorical
Units: Subjects
Female	140	147	287
Male	183	180	363

End points

Top of page

Reporting group title

Lenalidomide

Reporting group description

Lenalidomide 25mg/ day 3 weeks every 4 weeks for 24 months

Reporting group title

Placebo

Reporting group description

Placebo 25mg/day 3 weeks every 4 weeks for 24 months

Primary: PFS-FAS maintenance

Top of page

End point title

PFS-FAS maintenance ^[1]

End point description

Remark : The Median-PFS was not reached for Lenalidomide Arm at the end of study

End point type

Primary

End point timeframe

From the date of randomization to the date of first documented disease progression or relapse assessed by a blinded independent response adjudication committee, or death from any cause whichever occurs first.

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: Median PFS not reached at the end of the study in LEN arm Median OS not reached at the end of the study in both arms

End point values	Lenalidomide	Placebo
Number of subjects analysed	323	327
Units: months
number (not applicable)	0	88.9

No statistical analyses for this end point

Secondary: Overall survival

Top of page

End point title

Overall survival

End point description

Remark : The Median-OSwas not reached for both Arms at the end of study

End point type

Secondary

End point timeframe

OS measured from the date of randomization to the date of death from any cause.

End point values	Lenalidomide	Placebo
Number of subjects analysed	323	327
Units: months
number (not applicable)
OS_FAS maintenance	0000000	0000000

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Adverse events (AE) regardless of seriousness or relationship to Investigational Product that occurred after the informed consent up to 60 days after the last study drug administration

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Lenalidomide

Reporting group description

Lenalidomide 25mg/ day 3 weeks every 4 weeks for 24 months

Reporting group title

Placebo

Reporting group description

Placebo 25mg/day 3 weeks every 4 weeks for 24 months

Serious adverse events	Lenalidomide	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	99 / 322 (30.75%)	92 / 323 (28.48%)
number of deaths (all causes)	98	91
number of deaths resulting from adverse events	0	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
subjects affected / exposed	9 / 322 (2.80%)	27 / 323 (8.36%)
occurrences causally related to treatment / all	7 / 15	5 / 40
deaths causally related to treatment / all	0 / 0	0 / 3
Vascular disorders
Vascular disorders
subjects affected / exposed	4 / 322 (1.24%)	6 / 323 (1.86%)
occurrences causally related to treatment / all	3 / 4	2 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Surgical and medical procedures
subjects affected / exposed	1 / 322 (0.31%)	2 / 323 (0.62%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
General disorders and administration site conditions
subjects affected / exposed	3 / 322 (0.93%)	5 / 323 (1.55%)
occurrences causally related to treatment / all	1 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Immune system disorders
subjects affected / exposed	1 / 322 (0.31%)	0 / 323 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Reproductive system and breast disorders
subjects affected / exposed	0 / 322 (0.00%)	1 / 323 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
subjects affected / exposed	12 / 322 (3.73%)	7 / 323 (2.17%)
occurrences causally related to treatment / all	5 / 12	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Psychiatric disorders
subjects affected / exposed	3 / 322 (0.93%)	1 / 323 (0.31%)
occurrences causally related to treatment / all	1 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Investigations
subjects affected / exposed	1 / 322 (0.31%)	4 / 323 (1.24%)
occurrences causally related to treatment / all	1 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
subjects affected / exposed	9 / 322 (2.80%)	6 / 323 (1.86%)
occurrences causally related to treatment / all	3 / 9	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac disorders
Cardiac disorders
subjects affected / exposed	19 / 322 (5.90%)	14 / 323 (4.33%)
occurrences causally related to treatment / all	14 / 23	8 / 18
deaths causally related to treatment / all	0 / 1	0 / 1
Nervous system disorders
Nervous system disorders
subjects affected / exposed	11 / 322 (3.42%)	5 / 323 (1.55%)
occurrences causally related to treatment / all	2 / 12	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Blood and lymphatic system disorders
subjects affected / exposed	13 / 322 (4.04%)	7 / 323 (2.17%)
occurrences causally related to treatment / all	9 / 18	3 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Ear and labyrinth disorders
subjects affected / exposed	0 / 322 (0.00%)	1 / 323 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Eye disorders
subjects affected / exposed	0 / 322 (0.00%)	2 / 323 (0.62%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Gastrointestinal disorders
subjects affected / exposed	10 / 322 (3.11%)	7 / 323 (2.17%)
occurrences causally related to treatment / all	7 / 13	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Hepatobiliary disorders
subjects affected / exposed	6 / 322 (1.86%)	2 / 323 (0.62%)
occurrences causally related to treatment / all	3 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
subjects affected / exposed	8 / 322 (2.48%)	2 / 323 (0.62%)
occurrences causally related to treatment / all	6 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Renal and urinary disorders
subjects affected / exposed	2 / 322 (0.62%)	3 / 323 (0.93%)
occurrences causally related to treatment / all	1 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Endocrine disorders
subjects affected / exposed	3 / 322 (0.93%)	1 / 323 (0.31%)
occurrences causally related to treatment / all	2 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
subjects affected / exposed	5 / 322 (1.55%)	1 / 323 (0.31%)
occurrences causally related to treatment / all	3 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Infections and infestations
subjects affected / exposed	25 / 322 (7.76%)	15 / 323 (4.64%)
occurrences causally related to treatment / all	17 / 29	2 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Metabolism and nutrtion disorders
subjects affected / exposed	2 / 322 (0.62%)	4 / 323 (1.24%)
occurrences causally related to treatment / all	2 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Lenalidomide	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	197 / 322 (61.18%)	176 / 323 (54.49%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
subjects affected / exposed	1 / 322 (0.31%)	1 / 323 (0.31%)
occurrences all number	1	1
Vascular disorders
Vascular disorders
subjects affected / exposed	14 / 322 (4.35%)	9 / 323 (2.79%)
occurrences all number	14	9
Surgical and medical procedures
Surgical and medical procedures
subjects affected / exposed	2 / 322 (0.62%)	7 / 323 (2.17%)
occurrences all number	2	10
General disorders and administration site conditions
General disorders and administration site conditions
subjects affected / exposed	31 / 322 (9.63%)	19 / 323 (5.88%)
occurrences all number	36	20
Immune system disorders
Immune system disorders
subjects affected / exposed	2 / 322 (0.62%)	2 / 323 (0.62%)
occurrences all number	2	2
Reproductive system and breast disorders
Reproductive system and breast disorders
subjects affected / exposed	4 / 322 (1.24%)	1 / 323 (0.31%)
occurrences all number	4	1
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
subjects affected / exposed	16 / 322 (4.97%)	8 / 323 (2.48%)
occurrences all number	19	8
Psychiatric disorders
Psychiatric disorders
subjects affected / exposed	7 / 322 (2.17%)	14 / 323 (4.33%)
occurrences all number	9	15
Investigations
Investigations
subjects affected / exposed	10 / 322 (3.11%)	17 / 323 (5.26%)
occurrences all number	11	22
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
subjects affected / exposed	34 / 322 (10.56%)	32 / 323 (9.91%)
occurrences all number	49	50
Cardiac disorders
Cardiac disorders
subjects affected / exposed	9 / 322 (2.80%)	2 / 323 (0.62%)
occurrences all number	11	4
Nervous system disorders
Nervous system disorders
subjects affected / exposed	42 / 322 (13.04%)	35 / 323 (10.84%)
occurrences all number	55	45
Blood and lymphatic system disorders
Blood and lymphatic system disorders
subjects affected / exposed	193 / 322 (59.94%)	93 / 323 (28.79%)
occurrences all number	719	194
Ear and labyrinth disorders
Ear and labyrinth disorders
subjects affected / exposed	2 / 322 (0.62%)	6 / 323 (1.86%)
occurrences all number	2	7
Eye disorders
Eye disorders
subjects affected / exposed	6 / 322 (1.86%)	2 / 323 (0.62%)
occurrences all number	6	2
Gastrointestinal disorders
Gastrointestinal disorders
subjects affected / exposed	32 / 322 (9.94%)	20 / 323 (6.19%)
occurrences all number	43	32
Hepatobiliary disorders
Hepatobiliary disorders
subjects affected / exposed	0 / 322 (0.00%)	1 / 323 (0.31%)
occurrences all number	0	3
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
subjects affected / exposed	47 / 322 (14.60%)	12 / 323 (3.72%)
occurrences all number	64	13
Renal and urinary disorders
Renal and urinary disorders
subjects affected / exposed	2 / 322 (0.62%)	1 / 323 (0.31%)
occurrences all number	2	2
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
subjects affected / exposed	23 / 322 (7.14%)	16 / 323 (4.95%)
occurrences all number	28	20
Infections and infestations
Infections and infestations
subjects affected / exposed	114 / 322 (35.40%)	107 / 323 (33.13%)
occurrences all number	244	176
Metabolism and nutrition disorders
Metabolism and nutrition disorders
subjects affected / exposed	7 / 322 (2.17%)	5 / 323 (1.55%)
occurrences all number	10	7

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

13 May 2009

Protocol V2 and ICF V2.1

13 Apr 2010

Protocol V3 and ICF V3

30 Aug 2011

Protocol V4 and ICF V4

06 Jul 2012

Protocol V5 and ICF V5 and ICF Bio V3

03 May 2013

Protocol V6 and ICF V6

20 Nov 2014

Protocol V7 and additional patient information V1

10 Oct 2017

Protocol V8

13 Feb 2019

Protocol V9

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

For support, Contact us.

The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

European Medicines Agency © 1995-Sat Apr 27 22:11:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands