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Clinical trial of MB-CART2019.1 compared with standard of care in participants with relapsed/refractory diffuse large B-cell lymphoma.
THE OBJECTIVE OF THIS STUDY IS TO DETERMINE WHETHER AN INVESTIGATIONAL DRUG CALLED MB-CART2019.1 IS MORE EFFECTIVE THAN A SECOND STANDARD CHEMOTHERAPY TREATMENT FOR YOUR DISEASE. THIS STUDY WILL ALSO INVESTIGATE THE SAFETY OF MB-CART2019.1 WHEN ADMINISTERED TO PATIENTS AND WILL DETERMINE WHETHER THERE ARE ANY CHANGES IN THEIR QUALITY OF LIFE.
Technical Summary
- PIVOTAL, RANDOMIZED, MULTICENTER, OPEN-LABEL PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MB-CART2019.1 COMPARED WITH STANDARD OF CARE IN PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (R/R DLBCL) WHO ARE NOT ELIGIBLE TO RECEIVE HIGH-DOSE CHEMOTHERAPY OR AUTOLOGOUS PROGENITOR CELL TRANSPLANTATION.
- Code EudraCT: 2020-003908- 14
- Protocol number: M-2020-371
- Promoter: Biogen Idec Iberica, S.L.
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* 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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