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
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
3 other identifiers
interventional
326
14 countries
81
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2015
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedStudy Start
First participant enrolled
August 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2018
CompletedResults Posted
Study results publicly available
February 28, 2019
CompletedMarch 19, 2019
March 1, 2019
2.5 years
April 29, 2015
January 24, 2019
March 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment
Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/micro liter \[mcL\]); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Approximately up to 2.5 years
Part B: Overall Survival
Overall Survival (OS) was defined as the time from the date of randomization to date of death from any cause. Median Overall Survival was estimated by using the Kaplan-Meier method. This endpoint is reported here for Part B only as per the planned analysis.
Approximately up to 2.5 years
Secondary Outcomes (5)
Part B: Event-free Survival (EFS) Based on Investigator Assessment
Approximately up to 2.5 years
Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate)
Approximately up to 2.5 years
Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi)
Approximately 2.5 years
Part B: Time to Best Response
Approximately 2.5 years
Part B: Duration of Response (DOR) Based on Investigator Assessment
Approximately 2.5 years
Study Arms (2)
Decitabine plus Talacotuzumab
EXPERIMENTALPart 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.
Decitabine
ACTIVE COMPARATORParticipants in Part B Arm 2 will receive decitabine on Day 1,2, 3, 4 and 5 of a 28-day cycle.
Interventions
Decitabine 20 milligram per square meter (mg/\[m\^2\]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle.
Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
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Orange, California, United States
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Aurora, Colorado, United States
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New Orleans, Louisiana, United States
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Detroit, Michigan, United States
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Lebanon, New Hampshire, United States
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New York, New York, United States
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Rochester, New York, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Herston, Australia
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Melbourne, Australia
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Perth, Australia
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South Woodville, Australia
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Woolloongabba, Australia
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Antwerp, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Liège, Belgium
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Mons, Belgium
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Turnhout, Belgium
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Wilrijk, Belgium
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Grenoble, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Nantes, France
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Paris, France
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Toulouse, France
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Dresden, Germany
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Düsseldorf, Germany
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Essen, Germany
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Frankfurt am Main, Germany
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Hamburg, Germany
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München, Germany
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Münster, Germany
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Ulm, Germany
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Würzburg, Germany
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Haifa, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Warsaw, Poland
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Chelyabinsk, Russia
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Dzerzhinsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Ryazan, Russia
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Samara, Russia
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Yekaterinburg, Russia
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Busan, South Korea
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Daegu, South Korea
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Hwasun Gun, South Korea
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Seoul, South Korea
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Badalona, Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Pozuelo de Alarcon, Madrid, Spain
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Salamanca, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Örebro, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Chiayi City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Ankara, Turkey (Türkiye)
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Atakum, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Bournemouth, United Kingdom
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Cardiff, United Kingdom
Unknown Facility
Wolverhampton, United Kingdom
Related Publications (1)
Peipert JD, Efficace F, Pierson R, Loefgren C, Cella D, He J. Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia. J Geriatr Oncol. 2022 Sep;13(7):935-939. doi: 10.1016/j.jgo.2021.09.007. Epub 2021 Sep 11.
PMID: 34521609DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Medical Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2015
First Posted
June 15, 2015
Study Start
August 4, 2015
Primary Completion
January 25, 2018
Study Completion
January 25, 2018
Last Updated
March 19, 2019
Results First Posted
February 28, 2019
Record last verified: 2019-03