EUCTR2015-001611-12-SE
Active, not recruiting
Phase 1
A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus JNJ-56022473(Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are notCandidates for Intensive Chemotherapy
ConditionsAcute Myeloid Leukemia (AML)MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000012984Therapeutic area: Diseases [C] - Cancer [C04]
DrugsDACOGEN
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 400
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
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
- •\-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
Investigators
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