Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Washington University School of Medicine
With
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years of age
Histologically confirmed diagnosis of CD19 positive diffuse large B-cell lymphoma (DLBCL) or transformed large cell lymphoma from low grade lymphoma.
Chemo-sensitive (defined by complete remission (CR) or partial remission (PR) to most recent chemo regimen) based on pre-transplant positron emission tomography (PET) within 2 months of autologous transplant
Patients with bulky disease are eligible for study provided that the patient not undergo radiation therapy until 30 days after the end of blinatumomab administration.
Available representative tissue (from fresh or formalin fixed paraffin embedded tissue) from the most recent biopsy or archival tumor tissue for Clonotype evaluation for minimal residual disease (MRD) testing.
You may not be if
Chemo-resistant (defined by stable disease (SD) or progressive disease (PD) to most recent chemo regimen)
Pregnant or breastfeeding
Active central nervous system (CNS) involvement of Non-Hodgkin's Lymphoma (NHL)
Clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Prior stem cell transplant
Concurrent hematologic or non-hematologic malignancy requiring treatment
HIV seropositive, or active Hepatitis A, B, or C infection.
Uncontrolled congestive heart failure (CHF) or other comorbid systemic illnesses or severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Eligibility Criteria to Begin Consolidation Therapy
A participant must meet all of the following criteria on Day +42 visit in order to continue on the study to begin consolidation therapy with blinatumomab.
Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky ≥ 60 %
Absence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke, sever brain injuries, dementia, or psychosis
Required clinical laboratory values:
* Absolute neutrophil count (ANC) ≥ 1,000
* Platelets ≥ 75,000
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless related to Gilbert's or Meulengracht's syndrome)
* Alkaline phosphatase ≤ 5 x ULN
* ALT and AST ≤ 5 x ULN
* Calculated or measured creatinine clearance ≥ 50ml/min
Clareo Health | Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
