Acute Myeloid Leukemia Clinical Trial
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
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.
Full Description
This is a 2-part, open-label, multicenter, Phase 2/3 study conducted in participants with AML who are suitable for experimental therapy (Part A) and in participants with untreated AML who are not eligible for intense induction chemotherapy or hematopoeitic stem cell transplantation (HSCT) (Part B). In Study Part A, the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile will be assessed to confirm the RP2D of 9 milligram per kilogram (mg/kg) talacotuzumab. In Study Part B, participants will be randomized in a 1:1 ratio into either decitabine + talacotuzumab (arm 1) or decitabine alone (arm 2). Blood and bone marrow sampling will be done in Part A and B for disease assessment, PK, PD, and biomarkers will be collected in all participants. Safety will be monitored throughout the study.
Eligibility Criteria
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
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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There is 1 Location for this study
Orange California, , United States
Aurora Colorado, , United States
New Orleans Louisiana, , United States
Detroit Michigan, , United States
Lebanon New Hampshire, , United States
New York New York, , United States
Rochester New York, , United States
Charleston South Carolina, , United States
Nashville Tennessee, , United States
Dallas Texas, , United States
Houston Texas, , United States
Herston , , Australia
Melbourne , , Australia
Perth , , Australia
South Woodville , , Australia
Woolloongabba , , Australia
Antwerp , , Belgium
Hasselt , , Belgium
Leuven , , Belgium
Liege , , Belgium
Mons , , Belgium
Turnhout , , Belgium
Wilrijk , , Belgium
Grenoble Cedex 9 , , France
Lyon Cedex 08 , , France
Marseille , , France
Montpellier , , France
Nantes Cedex 2 , , France
Paris Cedex 10 , , France
Toulouse Cedex 9 , , France
Dresden , , Germany
Düsseldorf , , Germany
Essen , , Germany
Frankfurt/Main , , Germany
Hamburg , , Germany
München , , Germany
Münster , , Germany
Ulm , , Germany
Würzburg , , Germany
Haifa , , Israel
Jerusalem , , Israel
Ramat Gan , , Israel
Tel Aviv , , Israel
Busan , , Korea, Republic of
Daegu , , Korea, Republic of
Hwasun Gun , , Korea, Republic of
Seoul , , Korea, Republic of
Katowice , , Poland
Krakow , , Poland
Lodz , , Poland
Lublin , , Poland
Warszawa , , Poland
Chelyabinsk , , Russian Federation
Dzerzhinsk , , Russian Federation
Ekaterinburg , , Russian Federation
Moscow , , Russian Federation
Nizhny Novgorod , , Russian Federation
Ryazan , , Russian Federation
Samara , , Russian Federation
Badalona, Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Pozuelo De Alarcon, Madrid , , Spain
Salamanca , , Spain
Sevilla , , Spain
Valencia , , Spain
Gothenburg , , Sweden
Stockholm , , Sweden
Uppsala , , Sweden
Örebro , , Sweden
Chiayi , , Taiwan
Taichung City , , Taiwan
Tainan City , , Taiwan
Taipei City , , Taiwan
Ankara , , Turkey
Atakum , , Turkey
Istanbul , , Turkey
Izmir , , Turkey
Bournemouth , , United Kingdom
Cardiff , , United Kingdom
Wolverhampton , , United Kingdom
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