Multicenter, randomized, double-blind, phase III study of REVLIMID(Lenalidomide) versus placebo in patients with low risk myelodysplastic syndrome (low and intermediate-1 IPSS) with alteration in 5q- and anemia without the need of transfusion. - SINTRA-REV

Fundación General de la Universidad de Salamanca0 个研究点目标入组 60 人开始时间: 2014年11月7日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•- The patient must, to the understanding of the investigator, be capable of meeting all requirements of the clinical trial.
•- The patient will have to freely sign the informed consent before undergoing any test of the trial which does not form part of the normal care of patients, knowing the patient that he/she can leave the trial at any time, without this damaging in any way his/her subsequent medical attention.
•- Age > 18 years.
•- The patient will have to have a diagnose of low risk MDS (low and intermediate-1 IPSS) associated to the loss of 5q, either as isolated abnormality or accompanied by other additional cytogenetic abnormalities.
•- MDS del(5q) with anemia (Hb ? 12 g/dL) transfusion independent, documented confirmation of not having received any transfusion of packed red blood cells due to his/her baseline disease (MDS).
•- The patient will have a general state measured according to the ECOG scale ? 2.
•- Be capable of meeting all scheduled visits of the study.
•- All woman patient with childbearing potential will have to understand the teratogenic risk of the drug under study and commit herself to and be capable of fulfilling it, to use an effective contraceptive method.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Any organic disease or psychiatric disorder which made possible that the patient did not sign nor understood the informed consent.
•- Having received any treatment for MDS.
•- MDS del(5q) with transfusion dependent anemia, documented confirmation that the patient has received some CH transfusion due to the baseline disease (MDS).
•- Pregnant women or on lactation period.
•- Any of the following lab abnormalities: Absolute count of neutrophils < 500/mm3, Platelet count < 25000/mm3, GOT or GPT in serum > 3 times the normal higher threshold, Total serum bilirubin > 2 times the normal higher threshold.
•- Prior history of other malign disease different to MDS (except for carcinoma of baseline cells or skin squamous, or cervix or breast in situ carcinoma) unless the patient is free from disease for more than 5 years.
•- Know hypersensibility or history of uncontrollable side effects to Lenalidomide.
•- Major surgery within the 4 weeks prior to the inclusion in the trial.
•- The patient has received any agent under research in the 30 days prior to the inclusion.
•- Known positivity for HIV; active or chronic hepatitis A, B or C infection (including patients who are tested anti-HBC positive and/or HBsAg positive) – serological testing for hepatitis A, B, C required.

发起方

Fundación General de la Universidad de Salamanca