2024-514351-14-00招募中2 期
ErythroSIM : Randomized prospective trial evaluating the efficacy of the antiCD38 monoclonal antibody isatuximab in the treatment of PCRA by major ABO mismatch after allogeneic hematopoietic stem cell transplantation
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 16
- 主要终点
- Time to obtention of transfusion independence for patients with PRCA: time interval between randomization (corresponding to the M6 post-transplant) and resolution of PRCA (date of resolution of reticulocytopenia) treated or not by the anti-CD 38 monoclonal antibody isatuximab
研究概览
简要总结
Efficacy of the treatment of PRCA by isatuximab after allogeneic hematopoietic stem cell transplant compared to supportive care only control group (reduction in PRCA resolution time in days)
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
- 分配方式
- Randomized
- 主要目的
- Randomized prospective trial evaluating the efficacy of the antiCD38 monoclonal antibody isatuximab
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 15 years or older
- •Having receiving an allogeneic hematopoietic stem cell transplantation in condition of major ABO mismatch
- •PCRA defined by persistent red blood cell transfusion dependence at day 60 post-transplant with reticulocytes count under 10 G/L despite full donor chimerism and a good leucocytes (>1 G/L) and platelet (>50G/L) recovery
- •No relapse or progression of underlying disease
- •Contraception methods must be prescribed during all the duration of the clinical trial and using effective contraceptive methods during treatment for women of childbearing age (continue abstinence from heterosexual intercourse is accepted) and for man during the study treatment period and for at least 5 months after the last dose of study treatment and refrain from donating sperm during this period
- •With health insurance coverage
- •Having signed a written informed consent (2 parents for patients aged less than 18)
排除标准
- •Aged < 15 years
- •Patient receiving thrombopoietin receptor agonists (ARTPO).
- •Patient receiving plasma or plasmapheresis exchanges after transplant.
- •Planned to receive any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- •Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.
- •Hypersensitivity to the active substance or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine, hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- •Who have any debilitating medical or psychiatric illness - Under tutorship or curatorship
- •Who not understand informed consent for an optimal treatment and follow-up
- •Relapse of underlying disease
- •Leucocyte chimerism < 95%
- •PRCA related to Parvovirus B19 infection (positive blood PCR)
- •Known to be HIV+ or to have hepatitis A, B, or C active infection
- •Active tuberculosis
- •Pregnancy (βHCG positive) or breast-feeding.
- •Patient receiving recombinant human erythropoietin.
- •Patient receiving proteasome inhibitor (Bortezomib for example).
结局指标
主要结局
Time to obtention of transfusion independence for patients with PRCA: time interval between randomization (corresponding to the M6 post-transplant) and resolution of PRCA (date of resolution of reticulocytopenia) treated or not by the anti-CD 38 monoclonal antibody isatuximab
Time to obtention of transfusion independence for patients with PRCA: time interval between randomization (corresponding to the M6 post-transplant) and resolution of PRCA (date of resolution of reticulocytopenia) treated or not by the anti-CD 38 monoclonal antibody isatuximab
次要结局
- -Number of red blood cell transfusions after randomization -Ferritin levels at M6, M9 and M15 post-transplant -Adverse events (CTC-AE grade ≥ 2) after randomization -Quality of life questionnaire (EORTC QLQ-C30- v3) at D60, D100, M6, M9, M12, M15 post-transplant
- Factors associated with spontaneous resolution of PRCA between D60 and M6 post-transplant
- - Antibody level (anti A and/or anti B titers) at D60, D100, M6 post-transplant then at each visit d15, d29, d45, and M3, M6, M9 post randomization,
- - Number of days of hospitalization, transfusions support and chelation treatments
研究者
Alienor XHAARD
Scientific
Assistance Publique Hopitaux De Paris
研究点 (16)
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