Clinical Trials Register

Summary
EudraCT Number:	2006-003750-23
Sponsor's Protocol Code Number:	LINFOTARGAM
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-03-20
Trial 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

2006-003750-23

A.3

Full title of the trial

Treatment With Dense Doses of Chemotherapy Plus Rituximab (R-CHOP/14) and Highly Active Antiretroviral Therapy (HAART) in Patients With Diffuse Large B Cell Lymphoma and Infection With the Human Immunodeficiency Virus (HIV)

TRATAMIENTO DE PRIMERA LINEA CON QUIMIOTERAPIA A DOSIS DENSAS Y RITUXIMAB (R-CHOP/14) JUNTO A TRATAMIENTO ANTIRETROVIRAL DE GRAN ACTIVIDAD (TARGA) EN PACIENTES CON LIFOMA B DIFUSO DE CELULAS GRANDES (LBDCG) E INFECCIÓN POR EL VIRUS DE LA INMUNODEFICIENCIA HUMANA (VIH)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Treatment With Chemotherapy and Antiretroviral Therapy in Patients With Diffuse Large B Cell Lymphoma and Infection With the Human Immunodeficiency Virus (HIV)

TRATAMIENTO CON QUIMIOTERAPIA JUNTO A TRATAMIENTO ANTIRETROVIRAL EN PACIENTES CON LIFOMA B DIFUSO DE CELULAS GRANDES E INFECCIÓN POR EL VIRUS DE LA INMUNODEFICIENCIA HUMANA (VIH)

A.4.1

Sponsor's protocol code number

LINFOTARGAM

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fundación PETHEMA
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	AMGEN
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CABYC, S.L.
B.5.2	Functional name of contact point	Project Management
B.5.3	Address:
B.5.3.1	Street Address	Avda. Somosierra, 12. Portal izqdo. 2ºG
B.5.3.2	Town/ city	San Sebastián de los Reyes (Madrid)
B.5.3.3	Post code	28703
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34916590433
B.5.5	Fax number	+34916548969
B.5.6	E-mail	juan.berges@cabyc.com

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	Yes
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	rituximab
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
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	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	N/A
D.3.9.4	EV Substance Code	SUB12570MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	375
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)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	Yes
D.3.11.13.1	Other medicinal product type	Anticuerpo monoclonal quimérico producido en células de mamífero en cultivo por cromatografía de afinidad e intercambio iónico.
D.IMP: 2
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	Yes
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	Ciclofosfamida
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
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	CYCLOPHOSPHAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	Ciclofosfamida
D.3.9.4	EV Substance Code	SUB06859MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	750
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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.IMP: 3
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	Yes
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	Doxorrubicina
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
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	DOXORUBICIN
D.3.9.1	CAS number	23214-92-8
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	hidroxildaunorrubicina
D.3.9.4	EV Substance Code	SUB06391MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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.IMP: 4
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	Yes
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	Vincristina
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
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	VINCRISTINE
D.3.9.1	CAS number	57-22-7
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	N/A
D.3.9.4	EV Substance Code	SUB00059MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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.IMP: 5
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	Yes
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	Prednisona
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PREDNISONE
D.3.9.1	CAS number	53-03-2
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	Prednisona
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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

Diffuse Large B Cell Lymphoma and HIV Infection

Linfoma B Difuso de Célula Grande (LBDCG) e infección por el virus de la inmunodeficiencia humana (VIH)

E.1.1.1

Medical condition in easily understood language

Diffuse Large B Cell Lymphoma and HIV Infection

Linfoma B Difuso de Célula Grande (LBDCG) e infección por el virus de la inmunodeficiencia humana (VIH)

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

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

1. Evaluar la aplicabilidad del tratamiento:
a) Evaluar la toxicidad del tratamiento según los criterios CTC (versión 3.0) del National Cancer Instute (NCI). (http://ctep.cancer.gov/reporting/ctc_v30.html)
b) Tasa de infecciones oportunictas y no oportunustas traas 6 ciclos de tratamiento R-CHOP administrados cada 14 días, asociado a TARGA en pacientes con LBDCG e infección por VIH.
c) Evaluar el cumplimiento terapéutico de los 6 ciclos de tratamiento con R-CHOP por lo que respecta a retrasos en la administracíón de los ciclos y a reducciones de la dosis de quimioterapia (dosis planificada adminsitrada en el plazo previsto).

E.2.2

Secondary objectives of the trial

1. Evaluar la eficacia del tratamiento en pacientes con LBDCG y VIH:
a) Determinar la tasa de respuestas globales y remisiones completas tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociado a TARGA.
b) Evaluar la duración de la respuesta tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociado TARGA.
c) Evaluar la probabilidad de supervivencia libre de evento a los 5 años tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociado a TARGA.
d) Evaluar la probabilidad de supervivencia global a los 5 años tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociados a TARGA.
2. Identificar los factores predictivos de respuesta tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días en pacientes con LBDCG e infección por VIH.
3. Evaluar el impacto de la combinación terapéutica R-CHOP y TARGA en los parámetros de la infección por VIH (carga viral del VIH y recuento de linfocitos CD4+)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Pacientes con infección por el VIH (tratados o dispuestos a iniciar tratamiento con TARGA) diagnosticados de LBDGC en cualquier estadio (I-IV según la clasificación de Ann Arbor) no tratados perviamente para el linfoma.
2. Positividad de los linfocitos B neoplásicos para CD20.
3. Edad de 18 a 70 años.
4. Cualquier puntuación del Índice Pronóstico Interbaciona (también aplicable a los LNH en pacientes infectados por el VIH) (ver Apéndice 4).
5. Puntuación de la escala funcional ECOG de 0 a 3 (ver Apéndice 1).
6. Consentimiento Informado por escrito.
7. Recuento absoluto de neutrófilos > 1,5x109/L
8. Ausencia de neoplasia sincrónica o metacrónica a excepción del carcinoma in situ de cérvix o de cáncer de piel distinto del melanoma.
9. Recuento de linfocitos CD4+ > o = 100/microlitros.

E.4

Principal exclusion criteria

1. Pacientes con LBDCG previamente tratado.
2. Pacientes con linfoma primario del SNC.
3. Pacientes con LNH de Burkitt o Burkitt-like.
4. Recuento de linfocitos CD4+ < 100/microlitros.
5. Infecciones oportunistas u otras neoplasias definitorias de SIDA en actividad.
6. Drogadicción activa.
7. Mujeres embarazadas o en periodo de lactancia, o adultos en edad fértil que no tomen un método contraceptivo eficaz.
8. Pacientes con alteración grave de la función renal (creatinina > 2,5 LSN) o hepática (bilirrubina, ALT o AST > 2,5 LSN), excepto si se sospecha que es debido a la propia enfermedad.
9. Insuficiencia cardíaca con fracción de eyección < 40%.
10. Pacientes con enfermedades psiquiátricas graves que puedan interferir con su capacidad para entender el estudio (incluyendo alcoholismo o drogadiccdión activa).
11. ECOG > 3 (ver Apéndice 1).
12. Pacientes con hipersensibilidad conocida a las proteínas murinas o a cualquier otro componente de los medicamentos del estudio.

E.5 End points

E.5.1

Primary end point(s)

- To evaluate the applicability of the treatment:
1. To evaluate the treatment toxicity according to the Common Terminology Criteria (CTC) version 3.0 of the National Cancer Institute (NCI).
2. To evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) administered every 14 days and highly active antiretroviral therapy (HAART) in patients with diffuse large B cell lymphoma (DLBCL) and HIV infection.
3. To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy (planned dose administered in predicted term).

Evaluación de la aplicabilidad del tratamiento:
- Variables de seguridad en los ciclos 1 a 6, específicamente: porcentaje de pacientes que presentan neutropenia febril y porcentaje de pacientes que ha presentado alguna infección.
- Proporción de sujetos que reciben todas las dosis de quimioterapia planificadas en el tiempo previsto.
- Porporción de ciclos de quimioterapia administrados en las dosis planificadas y en el tiempo previsto.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the study.

Finalización del estudio.

E.5.2

Secondary end point(s)

To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days (R-CHOP/14):
1. To determine the global response and complete remission tax.
2. To evaluate the duration of the response.
3. To evaluate the probability of event-free survival in 5 years.
4. To evaluate the probability of global survival in 5 years.

1. Evaluación de la eficacia:
- Tasa de respuesta global (remisión completa (RC) y remisión parcial (RP))
- Tasa de remisión completa (RC)
- Tasa de remisión completa no documentada/confirmada (RCu)
- Tasa de respuesta parcial (RP)
- Tasa de enfermedad estable (EE), progresión (P) y recaída (R)
- Supervivencia libre de evento (SLE) a los 5 años
- Supervivencia global (SG) a los 5 años
2. Factores predictores de respuesta: sexo, edad, estadío, ECOG, LDH, beta-2-microglobulina, enfermedad voluminosa, número de localizaciones nodales, número de localizaciones extranodales.
3. Análisis de las variables de la carga viral y CD4+ a lo largo del estudio

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of the study.

Finalización del estudio.

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

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

Yes

E.6.13.1

Other scope of the trial description

Supervivencia Global (SG), Supervivencia Libre de Enfermedad (SLE) y Factores Predictivos

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

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.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

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

El ensayo finalizará prematuramente si tras la inclusión de 25 pacientes la eficacia en términos de remisiones completas resulta ser significativamente inferior a la del grupo control x2. Asimismo, el estudio finalizará si la toxicidad resulta ser significativamente superior. Puesto que la toxicidad será valorada por órganos y grados, se emplearán métodos no paramétricos y se ajustará el nivel de significación para comparaciones múltiples.

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

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

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 2012-03-20.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

En caso de fracaso terapéutico y subsiguiente salida del presente protocolo, cada centro apliacará el tratamiento que considere más oportuno. Lo mismo es aplicable a las eventuales recaídas del LNH. Se recomiensa, sin embargo, seguir el protocolo del grupo GELTAMO, que contempla quimioterapia de rescate de transplante autogénico de progenitores hematopoyéticos.

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

2007-01-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-11-10

P. End of Trial
P.	End of Trial Status	Ongoing

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