A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Sponsor

Celgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03647124

Collaborator

(none)

560

Enrollment

Locations

93.6

Anticipated Duration (Months)

10.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Mantle-Cell	Drug: Lenalidomide

Detailed Description

This is a European multinational, retrospective, non-interventional study of participants with relapsed or refractory mantle cell lymphoma (R/R MCL). Potential sites will be identified where R/R MCL participants have been treated with lenalidomide. Site inclusion will be limited to countries where lenalidomide is reimbursed for this indication.

Study Design

Study Type:

Observational

Anticipated Enrollment :

560 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

A Non-interventional, Post-authorization Safety Study of Patients With Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and Characterize the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden

Actual Study Start Date :

Mar 13, 2019

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe	Drug: Lenalidomide Specified dose on specified days Other Names: Revlimid L04AX04

Arm

Intervention/Treatment

Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe

Drug: Lenalidomide

Specified dose on specified days

Other Names:

Revlimid

L04AX04

Outcome Measures

Primary Outcome Measures

To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting. [Approximately 8.5 years]
To quantify and characterize the event of TFR by tumor burden (assessed based on the last CT scan performed within a maximum of 2 months prior to initiation of administration of lenalidomide) in R/R MCL patients treated with lenalidomide in a real-world setting.

Secondary Outcome Measures

To quantify and characterize the proportion of early deaths by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting [Approximately 8.5 years]
To quantify and characterize the proportion of early deaths (defined as deaths within 20 weeks of initial administration of lenalidomide) by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Received at least one dose of lenalidomide commencing after 08 July 2016 for the treatment of relapsed refractory mantle cell lymphoma.

Informed consent of the patient or an authorized third person or authority, if required by law, given prior to data collection.

Patient must be ≥18 years of age at the time of signing the informed consent form.

Exclusion Criteria:

Patients will be excluded if they were participating in an interventional clinical trial during the treatment period under observation in this Post Authorization Safety Study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LKH Graz Medizinische Universitätsklinik	Graz		Austria	8036
2	LKH Hochsteiermark, Standort Leoben	Leoben		Austria	8700
3	Local Institution - 104	Leoben		Austria	8700
4	Salzburger Landeskliniken - Universitaetsklinikum Salzburg	Salzburger		Austria	5020
5	Landesklinikum Wiener Neustadt	Wiener Neustadt		Austria	2700
6	AKH Wien, Universitaetsklinik fuer Innere Medizin III	Wien		Austria	1090
7	CHRU de Brest - Hopital Morvan	Brest		France	29200
8	CHU de Caen, institut d'hematologie de basse Nomandie	Caen Cedex 9		France	14033
9	Centre Hospitalier de Versailles André Mignot	Le Chesnay		France	78157
10	Clinique Victor Hugo	Le Mans		France	72015
11	Institution: Hopital Prive du Confluent	Nantes		France	4402
12	Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)	Paris		France	75013
13	Centre Hospitalier de Saint-Quentin	Saint Quentin Picardie		France	2321
14	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse Cedex 9		France	31000
15	Local Institution - 305	Toulouse CEDEX 9		France	31059
16	Gesundheitszentrum St. Marien Gmbh	Amberg		Germany	92224
17	Studienzentrum Aschaffenburg	Aschaffenburg		Germany	63739
18	Berufsausuebungsgemeinschaft Kiehl/Stein	Frankfurt/ Oder Brandenburg		Germany	15236
19	Klinikum Garmisch-Partenkirchen Gmbh - Zentrum Fuer Innere Medizin	Garmisch-Partenkirchen Bavaria		Germany	82467
20	Praxis fuer Haematolgie, Onkologie und Palliativmedizin	Leipzig		Germany	04289
21	Local Institution - 256	Wuerzburg		Germany	97080
22	Universitaetsklinikum Wuerzburg	Wuerzburg		Germany	97080
23	Local Institution - 0617	Patras	Achaïa	Greece	26500
24	General University Hospital of Alexandroupolis	Alexandrouppoli		Greece	68100
25	General Anti-Cancer Hospital "Agios Savvas"	Athens		Greece	11522
26	Private hospital "Iatriko Psychikou", Athens	Athens		Greece	11525
27	General University Hospital of Athens "LAIKO", Athens	Athens		Greece	11527
28	General University Hospital "Attikon"	Chaidari		Greece	12462
29	Metaxa Cancer Hospital, Athens	Piraeous		Greece	18537
30	Theageneio General Hospital, Thessaloniki	Thessaloniki		Greece	54007
31	Ospedale di Busto Arsizio - ASST Valle Olona	Busto Arsizio		Italy	21052
32	Ospedale Policlinico San Martino - IRCCS	Genova		Italy	16132
33	Istituto Clinico Humanitas IRCCS	Milano		Italy	20089
34	Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico	Milano		Italy	20122
35	Istituto Europeo di Oncologia	Milano		Italy	20141
36	Azienda Ospedaliera Niguarda Ca' Granda	Milano		Italy	20162
37	Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia	Padova		Italy	35128
38	Azienda Ospedaliero - Universiaria di Parma	Parma		Italy	43126
39	Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo	Pavia		Italy	27100
40	Azienda Ospedaliero Universitaria Pisana	Pisa		Italy	56126
41	Arcispedale Santa Maria Nuova - AUSL Reggio Emilia	Reggio Emilia		Italy	42122
42	Infermi Hospital	Rimini		Italy	47923
43	Policlinico Umberto I , Universita La Sapienza	Roma		Italy	161
44	Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte	Siena		Italy	53100
45	Azienda Ospedaliera Citta della Salute e della Scienza di Torino	Torino		Italy	10126
46	Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza	Torino		Italy	10126
47	Ospedale Dell'Angelo Di Mestre	Venezia		Italy	30174
48	HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg	Den Haag		Netherlands	2545 AA
49	Hospital universitario de Alava	Alava País Vasco		Spain	1009
50	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
51	Hospital Regional Universitario Carlos Haya	Malaga		Spain	29730
52	Hospital de Orense	Ourense		Spain	32005
53	Complejo Hospitalario de Navarra	Pamplona Navarra		Spain	31008
54	Hospital Clínico Universiatrio de Salamanca	Salamanca		Spain	37007
55	Nuestra Senora de Valme	Sevilla		Spain	41014