EUCTR2018-001467-23-FR进行中（未招募）1 期
Dexamethasone plus salvage chemotherapy versus salvage chemotherapy alone in patients with first relapsed or refractory acute myeloid leukemia: a randomized, controlled, open-label, multicenter, phase III study. - DEXAML-03
CHU de Toulouse0 个研究点目标入组 142 人开始时间: 2019年2月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
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
入选标准
- •- 18 years of age or older
- •- Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) classification. First relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the following criteria :
- •First relapsed AML:
- •* First relapse occurred at least 90 days to 24 months after the first CR or CRi.
- •* The first CR or CRi had to result from no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator.
- •* The re-emergence of at least 5% leukemic blasts in bone marrow is not attributable to other causes, regardless of new or recurrent dysplastic changes or extramedullary disease, or the re-emergence of at least 1% blasts in the peripheral blood is not attributable to other causes such as regenerating marrow.
- •Refractory AML:
- •* Persistent AML was documented by bone marrow biopsy or aspirate at least 28 days after day 1 of the first induction cycle of 1 or 2 cycles of cytotoxic chemotherapy.
- •* Re-emergence of at least 5% leukemic blasts in bone marrow or at least 1% blasts in peripheral blood is not attributable to other causes such as regenerating marrow, and was less than 90 days after the first CR or CRi.
- •* Prior induction therapy had to include no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator.
- •- Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •- Left ventricular ejection fraction (LVEF) = 50% by echocardiogram or multi-gated acquisition (MUGA) scan; only applicable for patients who will receive intensive chemotherapy
- •- Serum creatinine = 150 µmol/L and/or total bilirubin = 1.5 × the upper limit of normal (ULN) and/or, aspartate aminotransferase (AST) = 2.5 × ULN and/or alanine aminotransferase (ALT) = 2.5 × ULN (unless related to AML or due to Gilbert’s syndrome)
- •- Any clinically significant non-hematological toxicity after prior chemotherapy must be resolved or of grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
- •- Women must be surgically or biologically sterile, or in post-menopause (amenorrheic for at least 12 months), or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days prior to the randomization, and agree to use a highly effective method of contraception throughout the entire duration of the study treatment (including dose interruptions) and until 3 months after the last study treatment administration. Men must be surgically or biologically sterile, or agree to use a highly effective method of contraception throughout the entire duration of the study treatment (including dose interruptions) and until 6 months after the last study treatment administration
- •- Registered to, or beneficiary of, social security insurance or equivalent
- •- Signed written informed consent by both the patient and the investigator prior to perf
排除标准
- •- Acute promyelocytic leukemia (M3 subtype of AML)
- •- More than 2 cycles of first line induction chemotherapy
- •- AML with Philadelphia chromosome or BCR-ABL1 or blast crisis stage of chronic myeloid leukemia
- •- Known or suspected central nervous system leukemia
- •- Undergoing allogeneic hematopoietic stem cell transplantation within 90 days prior to randomization, or being on immunosuppressive therapy for prophylaxis of graft-versus-host disease (GVHD), or experiencing GVHD within 2 weeks prior to randomization
- •- Use of any experimental, cytotoxic, or targeted, anti-leukemic therapy within 14 days prior to randomization, with the exception of hydroxyurea
- •- Formal contraindication to glucocorticoids
- •- Non-AML-associated organic or psychiatric severe disease that contraindicates use of study treatment
- •- Patients who may not be followed regularly in consultation because of psychological, family, social, or geographical reasons
- •- History of uncontrolled other malignancy for at least two years, with the exception of basal cell carcinoma and in situ cervix carcinoma
- •- Severe uncontrolled infection at time of inclusion
- •- Positive serology for HIV-1 or 2, and/or HTLV-1 or 2, and/or active viral infection with hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
- •- Pregnant (beta HCG positive) or breastfeeding woman
- •- Incapable patient of age, under guardianship, curatorship or safeguard of justice
- •- Patient Under State Medical Assistance
- •- Patient participating in any other interventional clinical trial or having participated in an interventional clinical trial of which the exclusion period is still ongoing.
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