Clinical Trials Register

Summary
EudraCT Number:	2009-017829-19
Sponsor's Protocol Code Number:	LFNK
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-12-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-017829-19

A.3

Full title of the trial

Ensayo clínico fase II controlado de inmunoterapia combinada con linfocitos efectores autólogos en pacientes con linfoma no Hodgkin folicular en tratamiento de mantenimiento con rituximab tras respuesta a primera línea de quimioterapia

A.4.1

Sponsor's protocol code number

LFNK

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Instituto Científico y Tecnológico de Navarra
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Linfocitos efectores autólogos obtenidos a partir de células linfomononucleadas expandidas con IL-2
D.3.2	Product code	Linfocitos efectores autólogos
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Linfocitos efectores autólogos obtenidos a partir de células linfomononucleadas expandidas con IL-2
D.3.10	Strength
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1000000000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Linfoma no Hodgkin folicular

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar el impacto del tratamiento sobre la supervivencia libre de progresión

E.2.2

Secondary objectives of the trial

1- Evaluar su seguridad
2- Evaluar su impacto sobre otros parámetros clínicos de eficacia
Supervivencia global y supervivencia causa-específica
Supervivencia libre de acontecimiento
Tiempo hasta el siguiente tratamiento
Tasa de respuestas completas tras el tratamiento
Calidad de vida medida según cuestionarios EORTC
3- Caracterizar el producto celular y correlacionar los hallazgos con la eficacia clínica:
4- Estudiar parámetros biológicos que puedan predecir la susceptibilidad al tratamiento:

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

|• Linfoma folicular CD20-positivo confirmado histológicamente de grado 1, 2 ó 3a, (véase el apéndice A)
• Capacidad para otorgar consentimiento informado y expresar su deseo de cumplir todos los requisitos del protocolo durante el periodo de estudio
• Pacientes no tratados previamente. El tratamiento con R-CHOP de inducción debe ser el de primera línea para los pacientes que sean incluidos en el estudio.
• Tratamiento de mantenimiento previsto con ciclos de rituximab trimestrales
• Estadio de Ann Arbor II, III o IV antes de recibir el tratamiento de quimioterapia con R-CHOP.
• Pacientes con alguno de los siguientes síntomas o signos que indican necesidad de tratamiento según los criterios del GELF antes de recibir el tratamiento de quimioterapia con R-CHOP:
o Masa ganglionar o extraganglionar (excepto el bazo) >7 cm en su diámetro
mayor o Síntomas B
o LDH o p2-microglobulina séricas elevadas
o Afección de al menos 3 territorios ganglionares (cada uno con un diámetro
mayor a 3 cm) o esplenomegalia osíndrome compresivo o derrame pleural / peritoneal
o Evidencia de insuficiencia medular secundaria a infiltración por el linfoma
• El paciente debe de haber alcanzado una respuesta parcial o completa al tratamiento de inducción.
• Edad >18 años y <75 años.
• Estado general <2 en la escala de ECOG (véase el apéndice C).
• Función hematológica adecuada en un plazo de 28 días antes del registro (a menos que las anomalías estén relacionadas con la extensión del linfoma), que incluye:
Hemoglobina > 8,0 g/dl (5,0 mmol/L)
Recuento absoluto de neutrófilos (RAN) > 1,5 x 109/L
Recuento de plaquetas > 100 x 109/L

E.4

Principal exclusion criteria

• Transformación a linfoma de grado alto (secundario a un LF de "grado bajo").
• Linfoma folicular de grado 3b.
• Linfoma folicular primario de la piel o del tracto gastro-intestinal
• Historia de enfermedad del SNC (o bien linfoma del SNC o meningitis linfomatosa).
• Tratamiento previo del linfoma folicular distinto al tratamiento de inducción estándar con R-CHOP
• Pacientes que toman regularmente corticosteroides durante al menos las últimas 4 semanas, a menos que se administren a una dosis equivalente a < 20 mg/día de prednisona.
• Pacientes con cánceres anteriores o concomitantes, excepto cáncer de piel distinto al melanoma , cáncer de cuello uterino adecuadamente tratado in situ u otra neoplasia de extensión limitada, tratada de forma curativa y libre de progresión durante tres o más años.
• Función renal alterada: Creatinina sérica > 2,0 mg/dl (197 u.mol/L),
• Función hepática alterada: bilirrubina total > 2,0 mg/dl (34 umol/L), AST (SGOT) > 3 x el límite superior normal, a menos que estas anomalías estén relacionadas con el linfoma.
• Infección conocida por VIH o infección activa por VHB o VHC < 4 semanas en el registro.
• Enfermedades subyacentes graves que a juicio del investigador puedan afectar a la capacidad del paciente para participar en el ensayo (por ejemplo, infección en curso, diabetes mellitus no controlada, úlceras gástricas, enfermedad autoinmune activa).
• Esperanza de vida < 6 meses.
• Embarazo o lactancia
• Hipersensibilidad conocida a rituximab u otras proteínas murinas o a alguno de los excipientes.
• Tratamiento dentro de un ensayo clínico en un plazo de 30 días previos a la entrada en el ensayo.
• Cualquier otro estado médico o psicológico coexistente que descarte la participación en el estudio o comprometa la capacidad para dar el consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

Supervivencia libre de progresión

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Information not present in EudraCT

E.8.1.2

Open

Information not present in EudraCT

E.8.1.3

Single blind

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

Information not present in EudraCT

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-12-17.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	29

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-01-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-08-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-11-30

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