Clinical Trials Register

Summary
EudraCT Number:	2006-006130-17
Sponsor's Protocol Code Number:	ACT-1
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-02-25
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

Austria - BASG

A.2

EudraCT number

2006-006130-17

A.3

Full title of the trial

ACT-1 (younger patients)
A randomized phase III study to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP versus 2-weekly CHOP alone and consolidated by autologous stem cell transplant, in young patients with previously untreated systemic peripheral Tcell lymphomas

A.3.1

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

ACT-1 (younger patients)
Efficacy of chemoimmunotherapy with Alemtuzumab given in combination with CHOP followed by autologous stem cell transplant, in young patients with previously untreated systemic peripheral Tcell lymphomas.

A.3.2

Name or abbreviated title of the trial where available

ACT-1

A.4.1

Sponsor's protocol code number

ACT-1

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	Nordic Lymphoma Group
B.1.3.4	Country	Denmark
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	Nordic Lymphoma Group
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Nordic Lymphoma Group
B.5.2	Functional name of contact point	Francesco D´Amore
B.5.3	Address:
B.5.3.1	Street Address	AArhus University Hospital
B.5.3.2	Town/ city	Aarhus
B.5.3.3	Post code	80000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4589497567
B.5.5	Fax number	+4589497599
B.5.6	E-mail	frandamo@rm.dk

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.2.1.1.1	Trade name	MabCampath
D.2.1.1.2	Name of the Marketing Authorisation holder	Genzyme Europe BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	MabCampath
D.3.2	Product code	EU/1/01/193/002
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALEMTUZUMAB
D.3.9.1	CAS number	216503-57-0
D.3.9.3	Other descriptive name	ALEMTUZUMAB
D.3.9.4	EV Substance Code	SUB12459MIG
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	30
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)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
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

Newly diagnosed non-cutaneous peripheral T-cell lymphoma (PTCL),
except alk-protein positive and negative anaplastic large cell lymphoma

E.1.1.1

Medical condition in easily understood language

non-cutaneous peripheral T-cell lymphoma (PTCL)

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	HLT
E.1.2	Classification code	10034622
E.1.2	Term	Peripheral T-cell lymphomas NEC
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Determination of the efficacy and safety of the monoclonal antibody
MabCampath® (alemtuzumab) combined with two-weekly CHOP
supported by G-CSF

E.2.2

Secondary objectives of the trial

Efficacy: Overall Response Rate, Complete Remission and Partial
Remission (ORR, CR, PR) after induction chemotherapy, ORR related to
tumoral CD52 status, eligibility for ASCT after induction in the young
population ( 60 years). Overall survival (OS). Progression-free Survival
(PFS). Safety. Adherence to protocol.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk ( 7.5 cm) and stages II to IV.

2. Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C):
Peripheral T-cell lymphoma, unspecified (PTCL NOS)
Angioimmunoblastic T-cell lymphoma
Enteropathy-type associated T-cell lymphoma
Subcutaneous panniculitis-like T-NHL (gd T-cell lymphoma)
Hepatosplenic gd T-cell lymphoma
Extranodal NK/T cell lymphoma, nasal type

3. Age 18-60 years at the time of randomization for young patients’
cohort

4. Life expectancy of 3 months or longer

5. ECOG performance status 0, 1 or 2 at randomization (see appendix D). PS 3 acceptable if lymphoma-related.

6.Measurable disease

7. Written informed consent

E.4

Principal exclusion criteria

1. Patients with NK/T-NHL of the following type:
Precursor T cell lymphoblastic lymphoma/leukemia
All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL)
Alk-positive and negative anaplastic large cell lymphoma
Blastic NK cell lymphoma
Cutaneous T-cell lymphoma, transformed or not
HTLV1-positive adult T-cell leukemia

2. Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.

3. Known hypersensitivity to murine or chimeric antibodies or proteins

4. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45%

5. Significant renal dysfunction (serum creatinin > 2x UNL), unless related to NHL

6. Significant hepatic dysfunction (total bilirubin ³ 30 μmol/l or transaminases ³ 2.5 times normal level), unless related to NHL

7. Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmonary function test shows FEV1<50% or a diffusion capacity <50% of the reference values

8. Suspected or documented central nervous system involvement by
NHL

9. Patients known to be HIV-positive

10. Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg

11. Patients with uncontrolled asthma or allergy, requiring systemic
steroid treatment

12. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal type

13. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

14. Unwillingness or inability to comply with the protocol

E.5 End points

E.5.1

Primary end point(s)

Event-Free-Survival

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint is the Event-free Survival (EFS). The EFS is defined by the time between
day of randomization until one of the following events occurs, whichever comes first:
• Disease progression during therapy
• Relapse after achievement of CR/CRu
• Institution of any additional unplanned anti-tumor treatment
• Death due to any cause
Patients who have not experienced an event at the time of analysis will be censored at the most
recent date of disease assessment.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Response will be formally evaluated in both arms after cycles 3 and 6 according to the criteria of
response, or evaluated after last cycle if treatment stopped earlier.

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

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

CHOP backbone in both arms

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Yes

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

LVLS

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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)

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

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.4.2

For a multinational trial

F.4.2.1

In the EEA

290

F.4.2.2

In the whole clinical trial

308

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)

routine oncological surveillance, as outlined in chapters 3.1.4 and 3.1.5 of the protocol

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

2010-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-03-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-12-31

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