ACTRN12624000006549尚未招募1 期
AMLM26/T3- 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 - LDAC + Venetoclax
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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
- Non-randomised 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
- •1. Meets inclusion criteria outlined in the AMLM26 Master Protocol (see ACTRN12621000439842 for details on the master protocol)
- •2. ECOG 0-2
- •3. 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
- •4. Subject must have adequate liver function as demonstrated by below, unless considered to be due to leukemic organ involvement
- •a. aspartate aminotransferase (AST) less than or equal to 3.0 × Upper Limit Normal (ULN)
- •b. alanine aminotransferase (ALT) less than or equal to 3.0 × ULN
- •c. bilirubin less than or equal to 1.5 × ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
- •5. Female subjects must be either postmenopausal defined as:
- •a. Age greater than 55 years with no menses for 12 or more months without an alternative medical cause.
- •b. Age less than or equal to 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level greater than 40 IU/L.
- •c. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •d. A Woman of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
- •6. Male subjects who are sexually active with a WOCBP, even if the male subject has undergone a successful vasectomy, must agree from Study Day 1 through at least 180 days after the last dose of study drug to use condoms and his female partner(s) must use at least one of the contraceptive measures (as defined in the protocol for female study subjects of childbearing potential). Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
排除标准
- •1. Presence of any general exclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol (see ACTRN12621000439842 for details on the master protocol)
- •2. Prior use of venetoclax with LDAC/HMA is allowed unless demonstrated to be refractory to this combination. Prior venetoclax monotherapy is allowed.
- •3. Subject is HIV positive
- •4. Prior allogeneic stem cell transplantation within 30 days of post-conditioning or on immunosuppression for graft vs host disease (GVHD) (except for sole immunosuppression with prednisolone of <10mg/day for GVHD management which is permitted)
- •5. 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. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) or patients who have past exposure to HepB (HBs antigen negative but HBc antibody positive and DNA negative) who do not require treatment may participate.
- •6. Treatment with any of the following within 7 days prior to the first dose of study drug:
- •a. Steroid therapy for anti-neoplastic intent
- •b. Moderate or strong CYP3A inducers
- •c. Moderate or strong cytochrome CYP3A inhibitors are prohibited 7 days prior to cycle 1 day 1. They are prohibited during venetoclax dose ramp-up in all phases. At other times they may be used if required with caution and with appropriate dose modifications for venetoclax
- •7. Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
- •a. Grapefruit or grapefruit products
- •b. Seville oranges (including marmalade containing Seville oranges)
- •c. Star fruit
- •8. Treatment with prior anti-leukemic therapy within 14 days prior to the first dose of study drug (except steroids see exclusion 5a)
- •9. Subject has been diagnosed with another malignancy, unless disease-free for at least 2 years and not needing active treatment. Subjects with fully excised BCC/SCC/CIN or other minor malignancy are not excluded.
- •10. Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation
- •11. Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or gated cardiac blood pool scan performed within 1 month prior to study entry results in a left ventricular ejection fraction that is greater than or equal to 45%.
研究者
相似试验
尚未招募
1 期
AMLM26/T1 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - Gilteritinib+ VenetoclaxAcute Myeloid LeukaemiaCancer - Leukaemia - Acute leukaemiaACTRN12624000082505Australasian Leukaemia and Lymphoma Group60
招募中
不适用
AMLM26 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - The Master ProtocolAcute myeloid leukaemia (AML)Cancer - Leukaemia - Acute leukaemiaACTRN12621000439842Australasian Leukaemia & Lymphoma Group500
尚未招募
1 期
AMLM26/T2 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - Ivosidenib + Venetoclaxacute myeloid leukaemiaCancer - Leukaemia - Acute leukaemiaACTRN12624000141549Australasian Leukaemia & Lymphoma Group69
招募中
1 期
AMLM26/T5 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - MBG453 OR MBG453 and Azacitidineacute myeloid leukaemiaCancer - Leukaemia - Acute leukaemiaACTRN12621001265864Australasian Leukaemia & Lymphoma Group60
招募中
1 期
AMLM26/T4 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - SNDX5613acute myeloid leukaemiaCancer - Leukaemia - Acute leukaemiaACTRN12622000582752Australasian Leukaemia & Lymphoma Group92