Hospital Clinico Universitario de Valencia | Nephrology Department
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About
The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Aged 18 years or older.
Participants with B-precursor ALL with any of the following:
Either refractory to primary induction therapy or refractory to at least 1 salvage therapy OR
In untreated first, second, third or greater relapse or refractory relapse
Relapsed or Refractory at any time after first salvage therapy.
Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT).
Greater than or equal to 5% blasts in the Bone Marrow (Exception: Isolated Non-central nervous system (CNS) extramedullary disease [EMD]).
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
The above is a summary, other inclusion criteria details may apply.
Exclusion criteria
The above is a summary, other exclusion criteria details may apply.
Primary purpose
Allocation
Interventional model
Masking
125 participants in 3 patient groups
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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