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Trial of Beleodaq-CHOP or Folotyn-COP with the CHOP dosing regimen in monotherapy in patients with newly diagnosed peripheral T lymphocyte lymphoma.
PART 1 OF THIS STUDY IS MAINLY AIMED AT FINDING OUT WHAT IS THE BEST DOSE OF BELINOSTAT AND PRALATREXATE TOGETHER FOR ADMINISTRATION TOGETHER WITH ANOTHER DRUG COMBINATION IN PART 2 OF THE STUDY. THE MAIN OBJECTIVE OF PART 2 OF THE STUDY IS TO EVALUATE THE SAFETY AND EFFICACY OF BELINOSTAT TOGETHER WITH CHOP (CYCLOPHOSPHAMIDE, HYDROXYDAUNORUBICIN [DOXORUBICIN], ONCOVIN [VINCRISTINE] AND PREDNISONE), AND THE SAFETY AND EFFICACY OF PRALATREXATE TOGETHER WITH COP (CHOP WITHOUT HYDROXYDAUNORUBICIN [DOXORUBICIN]) COMPARED TO CHOP IN MONOTHERAPY.
Technical Summary
- PHASE III, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF THE COMBINATION OF BELEODAQ-CHOP OR FOLOTYN-COP WITH THE CHOP MONOTHERAPY REGIMEN IN PATIENTS WITH NEWLY DIAGNOSED PERIPHERAL T-CELL LYMPHOMA.
- Code EudraCT: 2023-507803-76-00
- Protocol number: SPI-BEL-301
- Promoter: Acrotech
- Molecule/Drug: Beleodaq-CHOP o Folotyn-COP
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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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