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Clinical trial of MB- CART2019.1 compared to reference therapy in participants with relapsed/refractory diffuse large B-lymphocyte lymphoma
THE OBJECTIVE OF THIS STUDY IS TO FIND OUT IF AN INVESTIGATIONAL DRUG, CALLED MB-CART2019.1, IS MORE EFFECTIVE THAN A SECOND STANDARD CHEMOTHERAPY TREATMENT FOR THE DISEASE HE IS SUFFERING FROM. THIS STUDY WILL ALSO INVESTIGATE THE SAFETY OF MB-CART2019.1 WHEN GIVEN TO PATIENTS AND DETERMINE IF THERE IS ANY CHANGE IN THEIR QUALITY OF LIFE.
Technical Summary
- PHASE II, RANDOMIZED, MULTICENTER, UNBLINDED, MULTICENTER PIVOTAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MB- CART2019.1 COMPARED TO REFERENCE THERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-LYMPHOCYTE LYMPHOMA (LDLBG R-R) WHO ARE INELIGIBLE FOR HIGH-DOSE CHEMOTHERAPY OR PROGENITOR CELL AUTOLOGOUS TRANSPLANTS
- Code EudraCT: 2020-003908- 14
- Protocol number: M-2020-371
- Promoter: Biogen Idec Iberica, S.L.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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