High-risk Diffuse Large B-Cell Lymphoma (DLBCL) MedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1: 1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures 2. Age = 18 at time of informed consent 3. Subject must have untreated and histologically proven high-risk DLBCL defined by at least one of the following: • IPI 3 to 5 • Double-hit or higher double protein expression 4. Eastern Cooperative Oncology Group (ECOG) performance status = 2 5. Subject meets the criteria per investigator's institution to receive SOC R-chemotherapy (ie, R-CHOP [14 or 21] or R-DA-EPOCH/R-CHOEP) of 6 cycles. Subjects may be enrolled on study prior to cycle 1 or cycle 2 6. Adequate organ and bone marrow function determined within 14 days prior to enrollment defined as follows: Hematological: • Absolute neutrophil count (ANC) = 1.0 x 1000000000/L • platelet count = 75 x 1000000000/L • Hemoglobin = 8g/dL Renal: • creatinine clearance = 50 mL/min Cockcroft-Gault equation Hepatic: • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: Part 1: 1. Clinically relevant central nervous system (CNS) pathology requiring treatment such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis 2. Evidence of CNS involvement with DLBCL at disease evaluation obtained prior to starting blinatumomab 3. Current autoimmune disease or history of autoimmune disease with potential of CNS involvement 4. Subject has active infection requiring systemic therapy 5. Prior anti-CD19 therapies 6. Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti-hepatitis C virus positive) 7. History of other malignancy within the past 3 years with the following exceptions: • Malignancy treated with curative intent and with no known active disease present for = 3 years before enrollment and felt to be at low risk for recurrence by the treating physician • Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease • Adequately treated cervical carcinoma in situ without evidence of disease • Adequately treated breast ductal carcinoma in situ without evidence of disease • Prostatic intraepithelial neoplasia without evidence of prostate cancer • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ 8. Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing. 9. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge. 10. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 11. Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed while receiving blinatumomab and for an additional 48 hours after the last treatment dose of blinatumomab. (Females of child bearing potential should only be included after a negative highly sensitive urine or serum pregnancy test.) 12. Females of childbearing potential unwilling to use an effective method of contraception while receiving blinatumomab and for an additional 48 hours after last dose of blinatumomab. Note: The pregnancy, breastfeeding and contraceptive requirements are specific to blinatumomab. The investigator is responsible for providing the subject (male and female) with pregnancy and breastfeeding (female only) avoidance requirements for other medications (eg, SOC R-chemotherapy) given during the study. 13. Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of blinatumomab administered after frontline R-chemotherapy in newly diagnosed subjects with high-risk DLBCL.; Secondary Objective: - To estimate the efficacy of blinatumomab administered after frontline R-chemotherapy in newly diagnosed subjects with high-risk DLBCL. - To characterize the pharmacokinetic (PK) parameters of blinatumomab administered to subjects after frontline standard of care (SOC) ritixumab (R)-chemotherapy in newly diagnosed subjects with high risk DLBCL. ;Primary end point(s): Overall incidence and severity of treatment-emergent adverse events occurring during the blinatumomab treatment period graded by investigators according to Common Toxicology Criteria for Adverse Events (CTCAE) version 4.0 and characterized as related or unrelated to study drug (blinatumomab);Timepoint(s) of evaluation of this end point: 3 months, 6 months, 9 months and 1 year from the first dose of blinatumomab | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3 months, 6 months, 9 months and 1 year from the first dose of blinatumomab; Secondary end point(s): • ORR expressed as the proportion of subjects achieving CR and partial response (PR). Responses will be determined by central radiographic assessment using the Lugano Classification • Duration of response • CR rate • OS from first dose of blinatumomab • PFS at 1 year from first dose of blinatumomab • Hematopoietic stem cell transplantation (HSCT) rate • Blinatumomab PK parameters | — |
Countries
Canada, France, Germany, Spain, United Kingdom, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed