Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome (SINTRA-REV)
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|ClinicalTrials.gov Identifier: NCT01243476|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2010
Last Update Posted : April 26, 2018
This clinical trial is a phase III multicenter, randomized, double blind and controlled with placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment for 104 weeks until progression of the disease, which implies that the patient suffering from anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.
Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements.
Total number of patients:
In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the placebo branch.
First patient first visit: February 2010, and Last patient last visit expected in February 2016. (Recruitment was initially expected to take place over a period of 24 months and was expected to be finished in February 2012, but due to low rate of recruitment it was extended until the population sample is included in the trial).
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: Lenalidomide Other: Placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||January 2022|
Experimental treatment branch with Lenalidomide 5 mg/day (oral use)
Treatment with Revlimid (lenalidomide), oral use, 5 mg daily during study treatment (104 weeks).
Other Name: Revlimid 5 mg
Placebo Comparator: placebo
Placebo branch (oral use)
Placebo, oral use, daily during study treatment (104 weeks)
- Period until the progression of myelodysplastic syndrome [ Time Frame: 6 years (study treatment and follow up) ]To assess if treatment with Revlimid (Lenalidomide) extends the period until the progression to MDS of(5q) considered as transfusion independent, documented verification that the patient suffering from anemia due to MDS requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months). Revlimid will be compared to the current standard treatment for patients with low risk MDS associated with the loss of 5q without transfusion dependent anemia, which is the therapeutic abstention and monitoring until its progression.
- Safety [ Time Frame: 6 years (study treatment and follow up) ]Safety (type, frequency and severity [Criteria of normal terminology of adverse reactions of the National Cancer Institute (NCI CTCAE) version 3.0] of adverse reactions (AR)and list of the AR with Lenalidomide.
- Erythroid response [ Time Frame: 6 years (study treatment and follow up) ]Erythroid response according to the Criteria of the MDS International Work Team.
- Duration of the red blood cells transfusion independency [ Time Frame: 6 years (study treatment and follow up) ]Red blood cells transfusion independency,defined as the number of days elapsed between the randomization and the first transfusion after this period free of transfusions.
- Change of the hemoglobin concentration (Hb) in relation to baseline levels [ Time Frame: 6 years (study treatment and follow up) ]Change of the hemoglobin concentration (Hb) in relation to baseline levels of patients who show erythroid response.
- Variation in platelets and neutrophils absolute count in relation to baseline levels [ Time Frame: 6 years (study treatment and follow up) ]
- Cytogenetic response [ Time Frame: 6 years (study treatment and follow up) ]Cytogenetic response according to the Criteria of the MDS International Work Team.
- Bone marrow response [ Time Frame: 6 years (study treatment and follow up) ]Bone marrow response according to the Criteria of the MDS International Work Team.
- Global survival, Event Free Survival and Rate of Transformation to Acute Leukemia. [ Time Frame: 6 years (study treatment and follow up) ]
- Time from diagnose to transfusion independence. [ Time Frame: 6 years (study treatment and follow up) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243476
|Hospital de Cabueñes|
|Gijón, Asturias, Spain, 33394|
|Hospital Central de Asturias|
|Oviedo, Asturias, Spain, 33006|
|Hospital Universitari Germans Trias i Pujol (ICO Badalona)|
|Badalona, Barcelona, Spain, 08916|
|Hospital Son Llàtzer|
|Palma de Mallorca, Islas Baleares, Spain, 07198|
|Hospital de Cruces|
|Barakaldo, Vizcaya, Spain, 48930|
|Hospital Clínic i Provincial|
|Barcelona, Spain, 08036|
|Hospital Universitario Reina Sofía|
|Córdoba, Spain, 14004|
|Hospital Infanta Leonor|
|Madrid, Spain, 28031|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital General Universitario José Maria Morales Meseguer|
|Murcia, Spain, 30008|
|Hospital Clínico Universitario de Salamanca|
|Salamanca, Spain, 37007|
|Hospital Universitario Virgen del Rocío|
|Sevilla, Spain, 41013|
|Hospital Universitario La Fe|
|Valencia, Spain, 46009|
|Study Chair:||Consuelo del Cañizo, MD||Hospital Clínico Universitario de Salamanca|
|Study Chair:||María Díez Campelo, MD||Hospital Clínico Universitario de Salamanca|