ACTRN12621001265864招募中1 期
AMLM26/T5- INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in Acute Myeloid Leukaemia (AML)): A Multi-arm, Precision-based, Recursive, Platform Trial - MBG453 OR MBG453 and Azacitidine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patient must meet eligibility to come onto the Intercept Master Protocol (as detailed in linked entry ACTRN12621000439842).
- •In order to be eligible to the MBG453 treatment arms inclusion criteria includes:
- •- meet MRD eligibility for INTERCEPT therapy based on a screening sample taken no more than 28 days prior to cycle 1 of day 1 of treatment on this treatment arm. (An increase of MRD greater than or equal to 1 log from nadir to at least 0.01%, confirmed with a repeat central sample.) Eligibility will be confirmed by the MRD review committee.
- •- ECOG0-2
- •- Patients entering this arm post-allogeneic stem cell transplantation will need to have an absolute lymphocyte count of greater than or equal to 0.2 x 109/L and no evidence of active acute graft-versus-host disease (GVHD)
- •- Subject must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection
- •-Subject must have adequate liver function as demonstrated by:
- •- aspartate aminotransferase (AST) less than or equal to 3.0 × ULN
- •- alanine aminotransferase (ALT) less than or equal to 3.0 × ULN
- •- bilirubin less than or equal to 1.5 × ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
- •- agree to follow the recommended contraception procedures
排除标准
- •Patient must meet eligibility to come onto the Intercept Master Protocol (as detailed in linked entry ACTRN12621000439842).
- •In order to be eligible to the MBG453 treatment arms exclusion criteria includes:
- •- Prior allogeneic stem cell transplantation within 3 months of post-conditioning or on greater than or equal to 10mg/day prednisolone for graft vs host disease
- •- QT-interval corrected according to Fridericia’s formula (QTcF) greater than 470ms (except for right bundle branch block)
- •- Subject is HIV positive
- •- Patients with greater than or equal to 5% myeloblasts in bone marrow on morphologic assessment
- •- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- •a.Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- •b.Acute/Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment.
- •- Systemic chronic corticosteroid therapy (greater than or equal to 10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
- •- For initial enrolment to INTERCEPT therapy, patients who have received previous TIM3 inhibitor treatment are excluded. This exclusion criteria does not apply to patients crossing-over from MBG453 arm to the combination MBG453 + azacitidine arm, unless MBG453 was ceased due to MBG453-related toxicity.
- •- Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded
- •- History of or current drug-induced interstitial lung disease or pneumonitis grade greater than or equal to 2
- •- Subject has been diagnosed with another malignancy, unless disease-free for at least 2 years and not needing active treatment. Patients with fully excised BCC/SCC/CIN or other minor malignancy are not excluded
- •- Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation
- •- Use of any live vaccines against infectious diseases (i.e. Influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment
- •- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- •Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade greater than or equal to 2) with an LVEF of less than 40%, uncontrolled hypertension or clinically significant arrhythmia
- •Acute myocardial infarction or unstable angina pectoris less than 3 months prior to study entry
- •- Known hypersensitivity to azacitidine or mannitol.
研究者
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