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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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56022473AML2002
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Secondary ID [2]
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CR107273
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment
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Assessment method [1]
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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.
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Timepoint [1]
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Approximately up to 2.5 years
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Primary outcome [2]
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Part B: Overall Survival
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Assessment method [2]
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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.
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Timepoint [2]
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Approximately up to 2.5 years
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Secondary outcome [1]
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Part B: Event-free Survival (EFS) Based on Investigator Assessment
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Assessment method [1]
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EFS defined as time from randomization to treatment failure, relapse from CR/CRi, or death from any cause, whichever occurs first, per modified IWG criteria. Treatment failure: \>25% absolute increase in the bone marrow blast count from baseline to present assessment (example, 20% to 46%) on bone marrow aspirate (or biopsy in case of dry tap); Relapse: Bone marrow blasts greater than equal to (\>=)5%; reappearance of blasts in blood; or development of extramedullary disease; CR: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0\*10\^9/L (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL);independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. Endpoint reported is for Part B only as per planned analysis.
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Timepoint [1]
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Approximately up to 2.5 years
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Secondary outcome [2]
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Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate)
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Assessment method [2]
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Percentage of participants who achieved CR and CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (\<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0 \*10\^9/liter (L) (1000/ mcL); platelet count \>100 \*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<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.
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Timepoint [2]
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Approximately up to 2.5 years
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Secondary outcome [3]
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Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi)
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Assessment method [3]
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Percentage of participants who achieved CR plus MRD-negative CRi were reported. MRD negativity defined as \<1 blast or leukemic stem cell in 10,000 leukocytes (MRD level \<10\^4).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/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<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.
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Timepoint [3]
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Approximately 2.5 years
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Secondary outcome [4]
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Part B: Time to Best Response
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Assessment method [4]
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Time to best response is calculated as the time from the randomization date to the first documented date for the best response for participants who achieved CR or CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (\<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0 \*10\^9/liter (L) (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<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.
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Timepoint [4]
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Approximately 2.5 years
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Secondary outcome [5]
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Part B: Duration of Response (DOR) Based on Investigator Assessment
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Assessment method [5]
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DOR defined as number of weeks from documented best response (CR or CRi) for participants who achieved CR or CRi to relapse, death due to relapse, date of censoring. As per modified IWG criteria: CR: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease;absolute neutrophil count \>1.0\*10\^9/L (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\* 10\^9/L (1000/mcL) or thrombocytopenia \<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.
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Timepoint [5]
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Approximately 2.5 years
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/01/2018
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Sample size
Target
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Accrual to date
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Final
326
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Herston
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- Melbourne
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- Perth
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Recruitment hospital [4]
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- South Woodville
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Recruitment hospital [5]
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- Woolloongabba
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- Herston
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- Melbourne
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- Perth
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- South Woodville
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Recruitment postcode(s) [5]
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- Woolloongabba
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Recruitment outside Australia
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California
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Grenoble Cedex 9
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Samara
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Badalona, Barcelona
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Istanbul
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Izmir
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Cardiff
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02472145
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/45/NCT02472145/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/45/NCT02472145/SAP_001.pdf
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT02472145
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