Clinical Trials Register

Summary
EudraCT Number:	2015-001611-12
Sponsor's Protocol Code Number:	56022473AML2002
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-06-01
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2015-001611-12

A.3

Full title of the trial

A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus JNJ-56022473
(Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not
Candidates for Intensive Chemotherapy

A.3.1

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

An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.

A.4.1

Sponsor's protocol code number

56022473AML2002

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	Janssen-Cilag International NV
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Janssen Research & Development, LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International NV
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+3171524 2166
B.5.5	Fax number	+3171524 2110
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	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	JNJ-56022473
D.3.2	Product code	JNJ-56022473
D.3.4	Pharmaceutical form	Lyophilisate 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	Talacotuzumab
D.3.9.3	Other descriptive name	JNJ-56022473
D.3.9.4	EV Substance Code	SUB176319
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	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	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	DACOGEN
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	DACOGEN
D.3.2	Product code	DACOGEN
D.3.4	Pharmaceutical form	Lyophilisate 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	DECITABINE
D.3.9.1	CAS number	2353-33-5
D.3.9.2	Current sponsor code	DACOGEN
D.3.9.3	Other descriptive name	DACOGEN
D.3.9.4	EV Substance Code	SUB06932MIG
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	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.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

Acute Myeloid Leukemia (AML)

E.1.1.1

Medical condition in easily understood language

Acute Myeloid Leukemia (AML)

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10000886
E.1.2	Term	Acute myeloid leukemia
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A: The primary objectives of Part A of the study are to assess safety and to confirm the recommended Phase 2 dose (RP2D) of JNJ-56022473 monotherapy.
Part B: The primary objectives of Part B of the study are to assess complete response (CR) rate and overall survival (OS) in patients with previously untreated AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus JNJ-56022473 at the RP2D or decitabine alone.

E.2.2

Secondary objectives of the trial

The secondary objectives are to assess the event-free survival (EFS), the overall response rate (ORR, defined as the rate of CR + complete response with incomplete blood count recovery [CRi]), the rate of CR plus MRD negative CRi, relapse-free survival (RFS), time to and duration of response, and the safety profile of study treatments; to assess the pharmacokinetics (PK) of decitabine and JNJ-56022473 when used alone or in combination; to assess the immunogenicity of JNJ-56022473 in combination with decitabine, to evaluate minimal residual disease (MRD) and to evaluate patient-reported outcomes measures (PRO) using the FACT LEU and
EQ-5D-5L instruments.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

AML according to WHO 2008 criteria fulfilling all the following criteria:

For Part A:
-Participants With AML: treatment naive or relapsed for whom experimental therapy is appropriate (as assessed by their treating physician)
For Part B:
≥75 years of age or
65 up to 75 years of age and have at least one of the following:
-Congestive heart failure or ejection fraction ≤50%
-Creatinine >2 mg/dL, dialysis or prior renal transplant
-Documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected, or forced expiratory volume in 1 second (FEV1) ≤65% of expected or dyspnea at rest requiring oxygen
-ECOG performance status of 2
-Prior or current malignancy that does not require concurrent treatment
-Unresolved infection
-Comorbidity that, in the Investigator’s opinion, makes the patient unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization
-De novo or secondary AML (post myelodysplastic syndrome [MDS] or myeloproliferative neoplasm [MPN] or after leukemogenic chemotherapy)
-Previously untreated AML (except: emergency leukapheresis and/or
hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of study therapy)
-Not eligible for an allogeneic hematopoietic stem cell transplantation
-ECOG Performance Status score of 0, 1 or 2
-A woman must be either: Not of childbearing potential: postmenopausal
(more than [>] 45 years of age with amenorrhea for at least 12 months; If,
of childbearing potential must be practicing a highly effective method of birth control
-A woman of childbearing potential must have a negative serum (betahuman
chorionic gonadotropin [betahCG]) or urine pregnancy test at screening
-A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment

E.4

Principal exclusion criteria

-Acute promyelocytic leukemia with t(15;17), or its molecular equivalent
(PML-RARalpha)

-For Part B only: Known leukemic involvement or clinical symptoms of
leukemic involvement of the central nervous system

-Participants who received prior treatment with a hypomethylating agent

-ForPart A only: Participants who did not recover from all clinically
significant toxicities (excluding alopecia and hematologic toxicities) of any
previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
-A diagnosis of other malignancy that requires concurrent treatment
-Any uncontrolled active systemic infection that requires treatment with IV antibiotics
-Active systemic hepatitis infection requiring treatment or other clinically active liver disease

E.5 End points

E.5.1

Primary end point(s)

Part A:
1 - to assess safety and determine dose-limiting toxicities(DLTs)
Part B:
1-Complete Response Rate
2-Overall Survival

E.5.1.1

Timepoint(s) of evaluation of this end point

1- Disease assessment will continue until treatment failure or relapse or clinical cutoff (Approximately up to 4 years after first participant enrollment)
2-Approximately up to 4 years after first participant enrollment

E.5.2

Secondary end point(s)

1-Overall response rate (ORR)
2- Event Free Survival (EFS)
3 - Rate of CR plus MRD negative CRi
4-Relapse free survival (RFS)
5- Number of Participants With Adverse Event
6-Number of Participants With Anti-drug Antibody at any Visit
7-Functional Assessment of Cancer Therapy Leukemia (FACT-Leu) Score
8-European Quality of Life- 5 Dimension 5 Level (EQ-5D-5L) Score
9-Area under the concentration- time curve between time t1 and t2 (AUC t1-t2)
10-Total Systemic Clearance (CL)
11- Maximum Observed Serum Concentration (Cmax)
12- Minimum Observed Concentration (Cmin)
13- Volume of Distribution
14-Time to Response
15- Duration of Response

E.5.2.1

Timepoint(s) of evaluation of this end point

1: Disease assessment will continue until treatment failure or relapse or clinical cutoff (Approx up to 4 years after first participant enrollment)
2-6: Approximately up to 4 years after first participant enrollment
7-8: Baseline to first followup after completion of study treatment, up to 4 years after first participant enrollment
9-13: Pre-specified time points during treatment through Cycle 1 (Days 1,2,3,4,8), cyc 2(Day 1), cyc 3,5 (Day 8) for part A and Cycle 1,4 (Days 1,5,8,9,22,23) cyc 2 (Days 1,8) for part B and also up to 30 days after last dose of any study drug in part A and B
14-15: Disease assessment will continue until treatment failure or relapse or clinical cutoff (Approximately up to 4 years after first participant enrollment)

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

Yes

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity, Biomarker

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)

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

DACOGEN

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Israel

Korea, Republic of

Russian Federation

Taiwan

Turkey

United States

Belgium

Germany

Italy

Poland

Spain

Sweden

United Kingdom

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

The end of the study is defined as when 270 deaths have occurred or at 6 months after the last subject is enrolled, whichever occurs first. At that time, follow up of subjects and data collection will end. Subjects who are continuing to derive benefit from treatment as assessed by their investigator will continue to receive treatment and be monitored for safety by the sponsor.

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)

Yes

F.1.3.1

Number of subjects for this age range:

400

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

164

F.4.2.2

In the whole clinical trial

400

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)

After the end of study, follow up of subjects and data collection will end. Subjects who are continuing to derive benefit from treatment as assessed by their investigator will continue to receive treatment and be monitored for safety by the sponsor.

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

2015-07-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-06-14

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