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
- Conditions
- Acute Myeloid Leukemia (AML)MedDRA version: 19.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001611-12-FR
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 326
AML according to WHO 2008 criteria fulfilling all the following 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:
=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 =50%
-Creatinine >2 mg/dL, dialysis or prior renal transplant
-Documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) =65% of expected, or forced expiratory volume in 1 second (FEV1) =65% of expected or dyspnea at rest requiring oxygen
-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 patient unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization
-De novo or secondary AML (post myelodysplastic syndrome [MDS] or myeloproliferative neoplasm [MPN] or after leukemogenic chemotherapy)
-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 (betahuman
chorionic gonadotropin [betahCG]) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
-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
-ForPart 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
-A diagnosis of other malignancy that requires concurrent treatment
-Any uncontrolled active systemic infection that requires treatment with IV antibiotics
-Active systemic hepatitis infection requiring treatment or other clinically active liver disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method