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Ensayo clínico de blinatumomab por vía subcutánea para el tratamiento de adultos con leucemia linfoblástica aguda de precursores B en situación refractaria o en recaída
THE PURPOSE OF THIS STUDY IS TO DETERMINE WHICH DOSES OF BLINATUMOMAB (THE STUDY DRUG) INJECTED SUBCUTANEOUSLY (JUST UNDER THE SKIN) ARE SAFE TO GIVE TO PATIENTS. THIS STUDY WILL ALSO DETERMINE WHETHER BLINATUMOMAB IS SAFE AND TOLERABLE (HAS GOOD OR BAD EFFECTS) AT THESE DOSES AND HOW BLINATUMOMAB ACTS INSIDE THE BODY WHEN GIVEN IN THIS WAY.
Technical Summary
- PHASE 1B OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY AND PHARMACOKINETICS OF SUBCUTANEOUS ADMINISTRATION OF BLINATUMOMAB FOR THE TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL). IMMUNOTHERAPY
- Code EudraCT: 2019-004780-52
- Protocol number: 20180257
- Promoter: Amgen, S.A.
* 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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