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.

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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.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

326

Study ID:

NCT02472145

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

326

Study ID:

NCT02472145

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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