Ensayo clínico de brentuximab vedotina o placebo en combinación con lenalidomida y rituximab en pacientes con linfoma difuso de células B grandes

THIS CLINICAL TRIAL USES A DRUG CALLED BRENTUXIMAB VEDOTIN. IT IS USED IN THIS STUDY BECAUSE THERE IS DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) THAT HAS COME BACK OR HAS NOT IMPROVED WITH THE LAST TREATMENT. THIS CLINICAL TRIAL ALSO USES DRUGS CALLED LENALIDOMIDE AND RITUXIMAB. THESE DRUGS HAVE BEEN APPROVED FOR CERTAIN BLOOD CANCERS AND OTHER DISEASES. BRENTUXIMAB VEDOTIN IS A TYPE OF DRUG CALLED AN ANTIBODY-DRUG CONJUGATE OR ADC. ADCS USUALLY HAVE 2 PARTS. -ANTIBODY: ANTIBODIES ARE PART OF THE IMMUNE SYSTEM. THEY USUALLY HELP PROTECT AGAINST DISEASE. IN BRENTUXIMAB VEDOTIN, AN ANTIBODY DESIGNED TO FIND AND ATTACH TO CANCER CELLS IN THE BODY IS USED. -DRUG: THE DRUG IS THE PART OF THE ADC THAT KILLS THE CELLS. THE PART OF BRENTUXIMAB VEDOTIN THAT KILLS CELLS IS A CHEMOTHERAPY DRUG CALLED MONOMETHYL AURISTATIN E (MMAE). IN BRENTUXIMAB VEDOTIN, THE ANTIBODY PART IS DESIGNED TO ATTACH TO CANCER CELLS SO THAT THE DRUG PART CAN KILL THEM. IT CAN ALSO ATTACH TO SOME NON-CANCEROUS CELLS IN YOUR BODY. BRENTUXIMAB VEDOTIN PLUS LENALIDOMIDE AND RITUXIMAB IS BEING USED TO FIND OUT IF THIS COMBINATION WORKS IN CASES OF DLBCL THAT HAVE COME BACK OR DO NOT GET BETTER WITH PREVIOUS TREATMENTS. THEY ALSO WANT TO STUDY SIDE EFFECTS. IN THIS STUDY THERE ARE 2 GROUPS. ONE GROUP WILL RECEIVE LENALIDOMIDE AND RITUXIMAB WITH BRENTUXIMAB VEDOTIN. THE OTHER GROUP WILL RECEIVE LENALIDOMIDE AND RITUXIMAB WITH A PLACEBO. A PLACEBO CONTAINS NO ACTUAL DRUG. THE MAIN OBJECTIVE OF THIS STUDY IS TO EVALUATE AND COMPARE PROGRESSION-FREE SURVIVAL (PFS) BETWEEN THE 2 TREATMENT GROUPS IN THE INTENTION-TO-TREAT (ITT) POPULATION, AS WELL AS TO EVALUATE AND COMPARE PFS BETWEEN THE 2 TREATMENT GROUPS IN THE CD30-POSITIVE POPULATION.