EUCTR2015-001611-12-DE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •-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
研究者
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