Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02472145




Registration number
NCT02472145
Ethics application status
Date submitted
29/04/2015
Date registered
15/06/2015
Date last updated
19/03/2019

Titles & IDs
Public title
An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Scientific title
A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus DACOGEN (Decitabine) Alone in Patients With AML Who Are Not Candidates for Intensive Chemotherapy
Secondary ID [1] 0 0
56022473AML2002
Secondary ID [2] 0 0
CR107273
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Decitabine 20 mg/m^2
Treatment: Drugs - Talacotuzumab 9 mg/kg

Experimental: Decitabine plus Talacotuzumab - Part A: For Cycle 1 of Part A, participants will receive talacotuzumab on Day 1. Starting from Cycle 2 of Part A, participants may receive decitabine on Day 1, 2, 3, 4, and 5, and talacotuzumab on Day 8 and 22 of a 28-day cycle.
Part B Arm 1: Participants will receive decitabine on Day 1, 2, 3, 4, and 5, and talacotuzumab on Day 8 and 22 of a 28-day cycle.

Active Comparator: Decitabine - Participants in Part B Arm 2 will receive decitabine on Day 1,2, 3, 4 and 5 of a 28-day cycle.


Treatment: Drugs: Decitabine 20 mg/m^2
Decitabine 20 milligram per square meter (mg/[m^2]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle.

Treatment: Drugs: Talacotuzumab 9 mg/kg
Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment
Timepoint [1] 0 0
Approximately up to 2.5 years
Primary outcome [2] 0 0
Part B: Overall Survival
Timepoint [2] 0 0
Approximately up to 2.5 years
Secondary outcome [1] 0 0
Part B: Event-free Survival (EFS) Based on Investigator Assessment
Timepoint [1] 0 0
Approximately up to 2.5 years
Secondary outcome [2] 0 0
Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate)
Timepoint [2] 0 0
Approximately up to 2.5 years
Secondary outcome [3] 0 0
Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi)
Timepoint [3] 0 0
Approximately 2.5 years
Secondary outcome [4] 0 0
Part B: Time to Best Response
Timepoint [4] 0 0
Approximately 2.5 years
Secondary outcome [5] 0 0
Part B: Duration of Response (DOR) Based on Investigator Assessment
Timepoint [5] 0 0
Approximately 2.5 years

Eligibility
Key inclusion criteria
- De novo or secondary acute myeloid leukemia (AML) (post myelodysplastic syndrome [MDS]
or myeloproliferative neoplasm [MPN] or after leukemogenic chemotherapy) according to
WHO 2008 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:

- Greater than or equal to (>=) 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 less than
or equal to (<=) 50 percent; creatinine greater than (>) 2 milligram per deciliter
(mg/dL); dialysis or prior renal transplant; documented pulmonary disease with lung
diffusing capacity for carbon monoxide (DLCO) <= 65 percent of expected, or forced
expiratory volume in 1 second (FEV1) <= 65 percent of expected or dyspnea at rest
requiring oxygen; eastern cooperative oncology group (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 participant
unsuitable for intensive chemotherapy and must be documented and approved by the
Sponsor before randomization

- Previously untreated AML (except: emergency leukopheresis 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 (beta-human chorionic
gonadotropin [beta-hCG]) 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

- For Part 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

- Any uncontrolled active systemic infection that requires treatment with intravenous
(IV) antibiotics

- A history of human immunodeficiency virus (HIV) antibody positive or tests positive
for HIV if tested at screening

- Active systemic hepatitis infection requiring treatment or other clinically active
liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2018
Sample size
Target
Accrual to date
Final
326
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Perth
Recruitment hospital [4] 0 0
- South Woodville
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- South Woodville
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerp
Country [11] 0 0
Belgium
State/province [11] 0 0
Hasselt
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liege
Country [14] 0 0
Belgium
State/province [14] 0 0
Mons
Country [15] 0 0
Belgium
State/province [15] 0 0
Turnhout
Country [16] 0 0
Belgium
State/province [16] 0 0
Wilrijk
Country [17] 0 0
France
State/province [17] 0 0
Grenoble Cedex 9
Country [18] 0 0
France
State/province [18] 0 0
Lyon Cedex 08
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
Country [21] 0 0
France
State/province [21] 0 0
Nantes Cedex 2
Country [22] 0 0
France
State/province [22] 0 0
Paris Cedex 10
Country [23] 0 0
France
State/province [23] 0 0
Toulouse Cedex 9
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Düsseldorf
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt/Main
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
München
Country [30] 0 0
Germany
State/province [30] 0 0
Münster
Country [31] 0 0
Germany
State/province [31] 0 0
Ulm
Country [32] 0 0
Germany
State/province [32] 0 0
Würzburg
Country [33] 0 0
Israel
State/province [33] 0 0
Haifa
Country [34] 0 0
Israel
State/province [34] 0 0
Jerusalem
Country [35] 0 0
Israel
State/province [35] 0 0
Ramat Gan
Country [36] 0 0
Israel
State/province [36] 0 0
Tel Aviv
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Busan
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Daegu
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Hwasun Gun
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Poland
State/province [41] 0 0
Katowice
Country [42] 0 0
Poland
State/province [42] 0 0
Krakow
Country [43] 0 0
Poland
State/province [43] 0 0
Lodz
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
Poland
State/province [45] 0 0
Warszawa
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Chelyabinsk
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Dzerzhinsk
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Ekaterinburg
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Nizhny Novgorod
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Ryazan
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Samara
Country [53] 0 0
Spain
State/province [53] 0 0
Badalona, Barcelona
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Pozuelo De Alarcon, Madrid
Country [57] 0 0
Spain
State/province [57] 0 0
Salamanca
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Sweden
State/province [60] 0 0
Gothenburg
Country [61] 0 0
Sweden
State/province [61] 0 0
Stockholm
Country [62] 0 0
Sweden
State/province [62] 0 0
Uppsala
Country [63] 0 0
Sweden
State/province [63] 0 0
Örebro
Country [64] 0 0
Taiwan
State/province [64] 0 0
Chiayi
Country [65] 0 0
Taiwan
State/province [65] 0 0
Taichung City
Country [66] 0 0
Taiwan
State/province [66] 0 0
Tainan City
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taipei City
Country [68] 0 0
Turkey
State/province [68] 0 0
Ankara
Country [69] 0 0
Turkey
State/province [69] 0 0
Atakum
Country [70] 0 0
Turkey
State/province [70] 0 0
Istanbul
Country [71] 0 0
Turkey
State/province [71] 0 0
Izmir
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Bournemouth
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Cardiff
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly
CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with
acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary
objective of study Part B are to assess complete response (CR) rate and overall survival (OS)
in participants with AML who are not eligible for intense induction chemotherapy and who are
randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02472145
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02472145