An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000012984; Acute Myeloid Leukemia (AML); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001611-12-DE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-15
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

De novo or secondary acute myeloid leukemia (AML) 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:
>/= 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 leukapheresis 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 standard intensive chemotherapy for induction and consolidation based on documented investigator assessment of disease and patient characteristics as recorded in the electronic case report form (eCRF); these parameters include age, Eastern Cooperative Oncology Group (ECOG) performance status score, cytogenetic risk group, and comorbidities (cardiac, infectious, hepatic, diabetes related, pulmonary, obesity related, cerebrovascular accident related, peptic ulcer, and others
-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

Exclusion Criteria

-Acute promyelocytic leukemia with t(15;17), or its molecular equivalent
(PMLRARalpha)

-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