2024-514484-25-00招募中2 期
PHASE II STUDY OF TOTAL MARROW AND LYMPHOID IRRADIATION (TMLI) ADMINISTERED IN COMBINATION WITH A MYELOABLATIVE REGIMEN BASED ON CYCLOPHOSPHAMIDE AND ETOPOSIDE AS A CONDITIONING FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (AHSCT) IN PATIENTS WITH HIGH-RISK MYELODYSPLASTIC SYNDROME OR ACUTE MYELOID LEUKEMIA
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2024年11月19日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Toxicity, which will be graded on both the Bearman Scale and the NCI CTCAE Scale v5.0
研究概览
简要总结
The antitumor activity of the conditioning regimen with TMLI, cyclophosphamide and etoposide followed by AHSCT will be evaluated by means of the progression-free survival (PFS) at 2 years after a safety-lead phase.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The participant has the ability and willingness to sign the informed consent document
- •Pulmonary function tests: forced expiratory volume in one second (FEV1) and Carbon Monoxide Diffusion Capacity (DLCO) (adjusted for Hb) ≥ 50% from expected normal value
- •Patients should undergo cardiac evaluation with an electrocardiogram showing no ischemic changes or clinically relevant arrhythmia, and a ≥50% ejection fraction established by Multi-Gated Acquisiton Scan (MUGA) or echocardiogram
- •ECG showing no ischemic changes or clinically significant arrhythmia
- •Men and women of childbearing potential agree to use appropriate contraceptives (hormonal or barrier contraception or abstinence) prior to study entry and for six months following the duration of study participation
- •The time elapsed since the end of the last induction or reinduction cycle must be greater than or equal to 14 days
- •Age ≥18 to ≤50 years
- •Karnofsky’s performance status should be ≥70%
- •Patients with myelodysplastic syndrome/acute myeloid leukemia or acute myeloid leukemia with relapsed/refractory active disease, or in complete remission or morphologic leukemia-free state with evidence of measurable residual disease as assessed by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing (in the case of FLT3-ITD-mutated AML)
- •All candidates for this study must have an HLA (A, B, C, DR) identical siblings who are willing to donate bone marrow or peripheral blood hematopoietic progenitors or an 8/8 matched unrelated donor. A single allele mismatch in A, B, C or DRB1 shall be allowed
- •Total bilirubin ≤ 1.5 x ULN OR 3 x ULN for Gilbert's disease
- •SGOT & SGPT ≤ 5 x LSN
- •Serum creatinine ≤ 1.3 mg/dL or creatinine clearance measured ≥ 80 mL/min for 24 hours of urine collection
- •Women of childbearing age only: Negative urine or serum pregnancy test
排除标准
- •Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded
- •Subjects who, in the opinion of the investigator, may not be able to meet the safety control requirements of the study
- •Previous radiation therapy, which would preclude the use of TMLI
- •Plans during the trial to receive any other investigational (non-trial-related) agents
- •Uncontrolled disease, including ongoing or active infection
- •History of allergic reactions attributed to compounds of chemical or biological composition similar to cyclophosphamide or etoposide
- •Patients with other active malignancies are not eligible for this study, other than the malignancies discussed
- •Patients with a psychological or medical condition that the patient's physician deems unacceptable to proceed with allogeneic hematopoietic stem cell transplantation
- •Women who plan to become pregnant or breastfeed during the trial
- •Patients who do not agree to practice effective forms of contraception
结局指标
主要结局
Toxicity, which will be graded on both the Bearman Scale and the NCI CTCAE Scale v5.0
Toxicity, which will be graded on both the Bearman Scale and the NCI CTCAE Scale v5.0
The evaluation of 2-year PFS. PFS will be defined as time from the start of treatment to the ate of death, disease relapse/progression, or date of last follow-up, and estimated using the Kaplan-Meier method
The evaluation of 2-year PFS. PFS will be defined as time from the start of treatment to the ate of death, disease relapse/progression, or date of last follow-up, and estimated using the Kaplan-Meier method
次要结局
- Overall survival (OS): patients are considered a failure for this endpoint if they die, regardless of the cause. The time to this event is the time from the start of protocol therapy to death, or the last follow-up, whichever comes first
- Cumulative incidence (CI) of recurrence/progression: The event is relapse/progression either extramedullary (EM) or at bone marrow (BM) (date and place). The time to this event is measured from the start of therapy. Death without relapse/progression is considered a competing risk. Surviving patients with no history of relapse/progression are censored at the time of last follow-up
- Complete remission (CR) rate at day 30 post-transplant: The event is whether or not the patient has a documented CR on day 30
- Non-relapse mortality (NRM2. NRM is measured from the start of therapy until non-disease-related death, or the last follow-up, whichever comes first
- Measurable residual disease (MRD): MRD monitoring assessed by multiparameter flow cytometry at 30, 90, 180, 360, 575 days, and 2 years post-transplant
- Incidence of infection: Microbiologically documented infections will be reported by site of illness, date of onset, severity, and resolution, if applicable. This data will be captured through the case report form and will be collected from day 0 to 100 days after transplantation
- Toxicities/Adverse Events: The Bearman Scale (non-hematologic) and CTCAE v. 5.0 (hematologic) will be employed. Dose/dose-volume toxicity characterization across organs will be assessed
- Acute graft-versus-host disease (GVHD) grades 2-4 and 3-4:. The endpoint will be assessed from day 0 to 100 days post-transplant
- Chronic graft-versus-host disease (GVHD): Chronic graft-versus-host disease is graded according to the NIH consensus staging. The first day of onset of chronic GVHD will be used to calculate cumulative incidence curves
研究者
Clara María Rosso Fernández
Scientific
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
研究点 (1)
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