EUCTR2015-001611-12-IT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 not Candidates for Intensive Chemotherapy - An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabin
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
- 326
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 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;
- •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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