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Clinical trial to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) and rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with diffuse large B-cell lymphoma.
THE AIM OF THE STUDY IS TO COMPARE THE TREATMENT SUCCESS AND TOLERABILITY OF A CHEMOTHERAPY CONSISTING OF A COMBINATION OF THE ACTIVE INGREDIENTS RITUXIMAB, IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH AND WITHOUT THE ADDITION OF POLATUZUMAB VEDOTIN (POLIVY®), AND TO CLARIFY WHETHER THE ADDITION OF THE LATTER ACTIVE INGREDIENT IMPROVES THE EFFICACY RESULTS WITH RESPECT TO EVENT-FREE SURVIVAL. POLIVY® IS AN ANTIBODY DIRECTED AGAINST LYMPHOMA CELLS TO WHICH A CELLULAR TOXIN BINDS. UPON CONTACT WITH THE LYMPHOMA CELL, THE DRUG ENTERS THE LYMPHOMA CELL, WHERE IT IS RELEASED AND ACTIVATES THE TOXIN, CAUSING LYMPHOMA CELL DEATH. IN THIS WAY, THE CHEMOTHERAPY IS PRIMARILY EFFECTIVE WITHIN THE LYMPHOMA CELLS AND NOT THROUGHOUT THE PATIENT'S BODY.
Technical Summary
- PROSPECTIVE, OPEN-LABEL PHASE III STUDY TO COMPARE POLATUZUMAB VEDOTIN PLUS RITUXIMAB, IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE (POLA-R-ICE) AND RITUXIMAB, IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE (R-ICE) ALONE AS SALVAGE THERAPY IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSED DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL). IMMUNOTHERAPY.
- Code EudraCT: 2019-002962-10
- Protocol number: GLA 2017-R2
- Promoter: GWT-TUD GmbH
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