NCT07130695招募中1 期
Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Assess the feasibility of olutasidenib after upfront acute myeloid leukemia (AML) therapy with intensive induction and/or consolidation in IDH1 mutant AML.
研究概览
简要总结
Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival.
详细描述
Up to 15 participants will receive treatment with olutasidenib 150 mg by mouth twice daily for up to 2 years. Participants will be regularly monitored for toxicities, adverse events, quality of life (QOL), and disease status. Once off treatment, participants will continue to be followed for a maximum of 2 years from date of enrollment for survival endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML). IDH1 mutation may be identified by NGS or PCR based methods and identified at time of diagnosis or any other time point prior to enrollment.
- •Completed induction and/or consolidation intended as per treating physician to reach complete response (CR),complete response with partial hematologic recovery (CRh), or complete response with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) at time of study enrollment Patients must be within 90 days of their last cycle of upfront therapy.
- •Age ≥18 years
- •Calculated creatinine clearance (by Cockroft-Gault) ≥30 mL/min
- •Total bilirubin ≤2 × upper limit of normal (ULN) Note: patients with Gilbert's syndrome may be included if total bilirubin is ≤3 × ULN and direct bilirubin is ≤2 × ULN
- •Serum aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ≤3 × ULN
- •Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2 or KPS >50%
- •Able to take oral medications
- •Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Effective methods of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double- barrier methods. (ie, combination of male condom with either cap, diaphragm or sponge with spermicide)
- •Male participants who are sexually active with a woman of childbearing potential and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug.
排除标准
- •History of hypersensitivity or allergic reaction to olutasidenib or its components
- •Corrected Q-T interval (QTc) (Fredericia calculation) > 450 ms (after corrective action is taken)
- •History of Torsades de Pointes
- •Any gastrointestinal condition thought by the treating investigator to impair oral absorption of medication
- •Stem cell transplant eligible and planned within 60 days of study start date in the opinion of the treating investigator
- •Uncontrolled intercurrent illness or infection (those with controlled human immunodeficiency virus (HIV), hepatitis, or other chronic infections are eligible)
- •Female participants who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug
- •Nursing women, women of childbearing potential with positive pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. (Appropriate method(s) of contraception include oral or injectable hormonal birth control, IUD, and double-barrier methods)
- •Male participants who intend to donate sperm during the course of this study or for 3 months after last dose
- •Participants receiving, or are expected to require during the study, any concomitant medications that may interfere with efficacy, metabolism, or safety of the investigational agent, including drugs known to cause QT prolongation. for which drug interactions with olutasidenib would be prohibitory
- •Concurrent chemotherapy for non-AML malignancy that is expected to interfere with the efficacy, metabolism, or safety of the agent under investigation
- •Received non-intensive upfront therapy including hypomethylating agents (HMA) /Venetoclax based
- •Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors
- •Other investigational agents in another clinical trial within 4 weeks prior to enrollment
- •Systemic corticosteroids above physiologic replacement doses (10mg/day prednisone or equivalent), unless used to tread IDH differentiation syndrome or as part of a pre-specified protocol exception
- •Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk or limit the participant's adherence with study requirements
研究组 & 干预措施
Olutasidenib Investigational Agent Administration
Experimental
150 mg by mouth twice daily.
干预措施: Olutasidenib Investigational Agent Administration (Drug)
结局指标
主要结局
Assess the feasibility of olutasidenib after upfront acute myeloid leukemia (AML) therapy with intensive induction and/or consolidation in IDH1 mutant AML.
时间窗: Up to 2 years
Feasibility defined as the number of participants with 75% protocol treatment compliance for a duration of at least 4 cycles (to include protocol defined dose delays), or until disease relapse or allogeneic hematopoietic stem cell transplant (alloHCT).
Assess the tolerability of olutasidenib after upfront AML therapy with intensive induction and/or consolidation in IDH1 mutant AML
时间窗: Up to 2 years
Incidence of grade ≥4 adverse events (AEs) attributable to study drug for duration of treatment on study
次要结局
- Measure progression free survival(Up to 2 years following end of treatment)
- Estimate overall survival (OS)(Up to 2 years following end of treatment)
- Assess mean residual disease (MRD) negativity rates by both PCR based and flow cytometric methodologies(Baseline, Cycle 3 Day 15, and End of Treatment (Each cycle is 28 days))
- Estimate rates of ability to proceed with transplant given maintenance opportunities.(Up to 2 years)
- Characterize quality of life (QOL) metrics by SF 36(Cycle 1Day 1, Cycle 2 Day 1, Cycle 4 day 1, and End of Treatment (EOT) (Each cycle is 28 days))
研究者
研究点 (1)
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