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Clinical trial of subcutaneous blinatumomab for the treatment of adults with refractory or relapsed B-precursor acute lymphoblastic leukemia
THE PURPOSE OF THIS STUDY IS TO DETERMINE WHICH DOSES OF BLINATUMOMAB (THE STUDY DRUG) ADMINISTERED BY SUBCUTANEOUS INJECTION (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 WORKS INSIDE THE BODY WHEN ADMINISTERED IN THIS WAY.
Technical Summary
- AN OPEN-LABEL PHASE 1B STUDY TO INVESTIGATE THE SAFETY AND PHARMACOKINETICS OF SUBCUTANEOUS BLINATUMOMAB ADMINISTRATION FOR THE TREATMENT OF ADULTS WITH REFRACTORY OR RELAPSED B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL R/R). IMMUNOTHERAPY
- Code EudraCT: 2019-004780-52
- Protocol number: 20180257
- Promoter: Amgen, S.A.
- Molecule/Drug: Blinatumomab
* 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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