2024-516873-57-00尚未招募2/3 期
Phase 3 trial aimed at improving the overall survival of AML in adults aged 18 to 60 by comparing high-dose idarubicin with daunorubicin at induction, high-dose and intermediate-dose cytarabine at consolidation and mycophenolic acid as standard prophylaxis in the prevention of graft versus host disease in allograft patients in first complete remission after reduced conditioning: Backbone Inter-Group-1 (BIG-1) trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 3,100
- 试验地点
- 54
- 主要终点
- For R1 and R2 randomizations: The primary endpoint will be a comparison of overall survival (OS) at 3 years according to the treatment considered (idarubicin vs. daunorubicin for randomization 1, and high-dose cytarabine 3.0 g/m2 vs. intermediate-dose cytarabine 1.5 g/m2 for randomization 2). For R3 randomization: The primary endpoint will be the cumulative incidence of grade II to IV acute GvHD at D100, compared according to the GvHD prophylaxis regimen considered (standard regimen or mycopheno
研究概览
简要总结
-
For R1 and R2 randomisations: Overall survival at 3 years, both for the comparison idarubicin versus daunorubicin at induction (R1), and for the comparison cytarabine 1.5 g/m2 versus cytarabine 3.0 g/m2 by bolus post-induction (R2)
-
For R3 randomization: Cumulative incidence of grade II to IV acute GvHD at D100
-
For R4 randomisation(s): Leukemia-free survival at 18 months
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: • Patients aged 18 and over but under 61 years old • Patients with AML, de novo or secondary to myelodysplastic syndrome or cancer therapy ("therapy-related" AML) • Not previously treated for AML (except hydroxyurea) or MDS (except with EPO) • General condition maintained (ECOG performance scale ≤ 3) • No severe uncontrolled infection • No cardiac contraindications from the use of anthracyclines (decompensated or uncontrolled coronary insufficiency, recent myocardial infarction, current manifestations of cardiac insufficiency, uncontrolled rhythm disorders, ventricular ejection fraction < 50%) • AST and ALAT ≤ 2.5 times upper limit of normal (ULN), total bilirubin ≤ 2 times ULN, creatinine < 150 μmol/L unless these biological abnormalities are related to leukemia • Search for FLT3 gene mutations(FLT3-ITD or FLT3-TKD), in a local or centralized laboratory • Use of an effective contraceptive method For patients treated with midostaurin: - Women of childbearing potential should use an effective method of contraception for the duration of treatment and up to 5 months after discontinuation of treatment - Men should use condoms during sexual intercourse, for the duration of treatment and up to 5 months after stopping midostaurin. • Patients who are members or beneficiaries of a social security scheme • Having read and understood the information letter and signed the informed consent form Post-induction: R4-VOS randomization for cytarabine and vosaroxine combination R4-VOS randomization is stopped as of 05/02/
- •Post-induction: R4-VOS randomization for cytarabine and dexamethasone combination R4-DEX randomization is discontinued as of 04/27/
- •Post-induction: R4-VEN randomization for cytarabine and venetoclax combination • Patient included in the BIG-1 protocol • Patient with AML in CR or CRp/CRi after induction or salvage therapy for randomized phase 2 (confirmed within 15 days prior to R4-VEN randomization) • Patient classified in the favorable or intermediate risk group according to the prognostic classification of the BIG-1 protocol • General condition maintained (ECOG performance scale ≤ 2) • Creatinine ≤ 150 μmol/L, total bilirubin ≤ 1.5 X ULN; AST and ALAT ≤ 2.5 times upper limit of normal (ULN) • Signed the specific consent for the venetoclax study • LVEF ≥ 40% 4 • No severe uncontrolled infection • Women of childbearing potential must have uninterrupted effective contraception during the study and for at least 3 months after the end of treatment Prior to CSH allograft: R3 randomization for GvHD prophylaxis study (R3-RIC) R3-RIC randomization is discontinued as of 10/09/2023.
排除标准
- •With Diagnosis: • Patients with acute promyelocytic leukemia (AML3) with either t(15;17) or a positive test for the PML-RARA transcript, or AML in the CBF group with either t(8;21), t(16,16) or inv(16), or a positive test for the transcripts associated with these cytogenetic abnormalities (RUNX1-RUNX1T1, CBFB-MYH11). • Patients with AML secondary to a previously known myeloproliferative syndrome according to 2008 WHO classification • Patients with previous Philadelphia chromosome (Ph1+) AML or chronic myeloid leukemia • Patients with severe organic or psychiatric pathology presumed to be independent of AML and contra-indicating treatment, including allogeneic transplantation • Patients who, for psychological, family, social or geographical reasons, are unable to receive regular consultation services • Previous cancer, if uncontrolled for at least two years, with the exception of basal cell skin carcinoma and carcinoma in situ of the uterine cervix • No severe uncontrolled infection at the time of inclusion • Positive serology for HIV 1 or 2 or HTLV 1 or 2, or active hepatitis B or C infection • Pregnant (beta-hCG positive) or breast-feeding women • Looked-after adult patients who are under guardianship • Patient on State Medical Aid Post-induction: R4-VOS randomization for cytarabine and vosaroxine combination R4-VOS randomization is stopped as of 05/02/
- •Post-induction: R4-VOS randomization for cytarabine and dexamethasone combination R4-DEX randomization is discontinued as of 04/27/
- •Post-induction: R4-VEN randomization for cytarabine and venetoclax combination • Patient classified in the unfavorable risk group according to BIG-1 protocol classification • Patient included in R4-DEX • Uncontrolled severe infection such as sepsis, or multi-organ failure syndrome, uncontrolled fever • Documented, uncontrolled fungal infection (positive blood and cultures) • Previous myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 3 months prior to randomization • Patient on hemodialysis (HD) or peritoneal dialysis (PD) • Any severe, uncontrolled condition including diabetes, hypertension, gastric ulcer, psychiatric disorders, myasthenia gravis or glaucoma 5 • Pregnant (beta-hCG positive) or breast-feeding women • Patients previously treated with venetoclax • Active hepatitis B viral infection • Patient known to be HIV positive • Known hypersensitivity to any of the study drugs. • Concomitant treatment with a CYP3A4 inhibitor that cannot be stopped during phase 1 administration of venetoclax only. • During the randomized phase 2, in the case of IDAC + venetoclax randomized paients, if concomitant treatment with a CYP3A4 inhibitor cannot be stopped, the venetoclax dose will need to be reduced by 75%. Prior to CSH allograft: R3 randomization for GvHD prophylaxis study, R3-RIC • R3-RIC randomization is discontinued as of 10/09/2023.
结局指标
主要结局
For R1 and R2 randomizations: The primary endpoint will be a comparison of overall survival (OS) at 3 years according to the treatment considered (idarubicin vs. daunorubicin for randomization 1, and high-dose cytarabine 3.0 g/m2 vs. intermediate-dose cytarabine 1.5 g/m2 for randomization 2). For R3 randomization: The primary endpoint will be the cumulative incidence of grade II to IV acute GvHD at D100, compared according to the GvHD prophylaxis regimen considered (standard regimen or mycopheno
For R1 and R2 randomizations: The primary endpoint will be a comparison of overall survival (OS) at 3 years according to the treatment considered (idarubicin vs. daunorubicin for randomization 1, and high-dose cytarabine 3.0 g/m2 vs. intermediate-dose cytarabine 1.5 g/m2 for randomization 2). For R3 randomization: The primary endpoint will be the cumulative incidence of grade II to IV acute GvHD at D100, compared according to the GvHD prophylaxis regimen considered (standard regimen or mycopheno
次要结局
未报告次要终点
研究者
Prof. Mathilde Hunault
Scientific
Centre Hospitalier Universitaire D'Angers
研究点 (54)
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