Clinical Trials Register

Summary
EudraCT Number:	2013-003369-33
Sponsor's Protocol Code Number:	Uni-Koeln-1698
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-07-10
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

Germany - BfArM

A.2

EudraCT number

2013-003369-33

A.3

Full title of the trial

JeRiCHO (JAK-inhibition in recurrent classical Hodgkin Lymphoma): A phase II, open-label, prospective, non-randomized, multicenter clinical trial with the JAK-inhibitor ruxolitinib in patients with relapsed or refractory Hodgkin Lymphoma (HL).

JeRiCHO (JAK-inhibition in recurrent classical Hodgkin Lymphoma): Eine Phase II, unverblindete, prospektive, nichtrandomisierte, multizentrische klinische Studie mit dem JAK-Inhibitor Ruxolitinib für Patienten mit rezidiviertem oder refraktärem Hodgkin Lymphom (HL).

A.3.1

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

JeRiCHO: A study to improve the treatment of relapsed or refractory Hodgkin Lymphoma with JAK-inhibitor (Ruxolitinib).

JeRiCHO: EIne Studie zur Verbesserung der Behandlung von rezidivierten oder refraktären Hodgkin Lymphom Patienten mit dem JAK-Inhibitor (Ruxolitinib).

A.3.2

Name or abbreviated title of the trial where available

JeRiCHO (JAK-inhbition in recurrent classical Hodgkin Lymphoma)

JeRiCHO (JAK-Inhibiton bei rezidiviertem Hodgkin Lymphom)

A.4.1

Sponsor's protocol code number

Uni-Koeln-1698

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02164500

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	University of cologne
B.1.3.4	Country	Germany
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	Novartis Pharma GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	German Hodgkin Study Group
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Gleueler Straße 269-273
B.5.3.2	Town/ city	Cologne
B.5.3.3	Post code	50935
B.5.3.4	Country	Germany
B.5.4	Telephone number	004922147888200
B.5.5	Fax number	004922147888188
B.5.6	E-mail	ghsg@uk-koeln.de

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	Jakavi 5mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Ruxolitinib
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	Ruxolitinib
D.3.9.1	CAS number	1092939-17-7
D.3.9.3	Other descriptive name	RUXOLITINIB PHOSPHATE
D.3.9.4	EV Substance Code	SUB32897
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	5
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

relapsed or refractory
Hodgkin Lymphoma

rezidiviertes oder refraktäres Hodgkin Lymphom

E.1.1.1

Medical condition in easily understood language

reappearance of Hodgkin Lymphoma that did not respond to therapy

Rückfall eines Hodgkin Lymphoms oder Hodgkin Lymphom, das auf Therapie nicht ansprach

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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

• To determine the overall response rate (ORR, complete response [CR] + partial response [PR]) in patients with relapsed or refractory HL

E.2.2

Secondary objectives of the trial

• To determine the safety profile of ruxolitinib in patients with relapsed or refractory HL
• To estimate progression-free survival (PFS) and overall survival (OS)
• To explore biomarkers predictive of response to ruxolitinib
• To assess quality of life (QoL) before and during treatment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients with relapsed or refractory HL after any polychemotherapy regimen including HDCT and ASCT who are not eligible for (another) HDCT and ASCT; age: 18 to 99 years; ECOG ≤ 2, no major organ dysfunction (except HL related), written informed consent; Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L, platelets ≥ 100 x 109/L; Total bilirubin ≤ 2 x ULN (if >2 x ULN direct bilirubin is required and should be ≤1.5 x ULN); ASAT ≤ 3 x ULN (≤ 5 x ULN if liver involvement is present); serum creatinine ≤ 2 x ULN; ≥2 weeks since last tumor therapy

E.4

Principal exclusion criteria

Patients who have a history of another primary malignancy ≤ 2 years; Female patients who are pregnant or breast feeding; Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study drug start; Patients with a known history of HIV seropositivity, chronic active hepatitis

E.5 End points

E.5.1

Primary end point(s)

• ORR after two cycles (based on PET-CT)

E.5.1.1

Timepoint(s) of evaluation of this end point

After two cycles

E.5.2

Secondary end point(s)

• Adverse events during therapy
• ORR after two cycles (based on CT only)
• Treatment administration (dose reductions, duration of treatment)
• Progression free survival (PFS)
• Overall Survival (OS)
• Best response during therapy (based on PET-CT)
• Exploratory description of biomarkers
• QoL before therapy and at the restaging after two cycles

E.5.2.1

Timepoint(s) of evaluation of this end point

During an directly after therapy.
Restagings are performed every three months.
All patients will be followed for 12 months after off-treatment visit.

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)

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

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

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

Remission status of all patients achieving at least SD will be followed for 12 months after off-treatment visit.

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

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)

Treatment after discontinuation of the study drug will be continued according to local standards.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	German Hodgkin Study Group
G.4.3.4	Network Country	Germany

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-07-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-06-30

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