Phase 2
N=25
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse Large B-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01741792 ↗Enrolled (actual)
25
Serious AEs
91.8%
Results posted
Jul 2015
Primary outcome: Primary: Overall Objective Response Rate During Treatment Cycle 1 — 57.1; 100.0; 30.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blinatumomab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen Research (Munich) GmbH
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Objective Response Rate During Treatment Cycle 1 |
57.1; 100.0; 30.8 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response |
28.6; 0; 15.4 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Partial Response |
28.6; 100.0; 15.4 | — |
| SECONDARY Duration of Objective Response |
8.7; NA; 4.0 | — |
| SECONDARY Duration of Complete Response |
NA; NA | — |
| SECONDARY Duration of Partial Response |
3.3; NA; 2.0 | — |
| SECONDARY Progression-free Survival (PFS) |
3.7; NA; 1.6 | — |
| SECONDARY Overall Survival (OS) |
20.1; NA; 3.6 | — |
| SECONDARY Number of Participants With Adverse Events |
9; 2; 14; 9; 2; 13 | — |
| SECONDARY Blinatumomab Steady State Serum Concentration |
277; 565; 2800 | — |
| SECONDARY Leukocyte Counts |
6.376; 5.729; 6.819; 6.400; 3.764; 4.950 | — |
| SECONDARY Lymphocyte Counts |
0.779; 0.491; 0.382; 0.277; 0.472; 0.847 | — |
| SECONDARY Monocyte Counts |
0.638; 0.300; 0.202; 0.188; 0.318; 0.646 | — |
| SECONDARY Granulocyte Count |
4.968; 4.910; 6.235; 5.935; 2.974; 3.457 | — |
| SECONDARY CD19+ B-Cell Count |
0.026; 0.029; 0.001; 0.000; 0.000; 0.000 | — |
| SECONDARY CD19+ B-Cells as a Percentage of All Lymphocytes |
2; 4; 0; 0; 0; 0 | — |
| SECONDARY CD3+ T-Cell Count |
0.578; 0.349; 0.282; 0.199; 0.348; 0.613 | — |
| SECONDARY CD3+ T-Cells as a Percentage of All Lymphocytes |
72; 68; 70; 67; 73; 71 | — |
| SECONDARY CD4+ T-Cell Count |
0.254; 0.152; 0.131; 0.085; 0.170; 0.261 | — |
| SECONDARY CD4+ T-Cells as a Percentage of All Lymphocytes |
33; 28; 32; 29; 34; 30 | — |
| SECONDARY CD8+ T-Cell Count |
0.298; 0.186; 0.134; 0.102; 0.140; 0.299 | — |
| SECONDARY CD8+ T-Cells as a Percentage of All Lymphocytes |
37; 37; 35; 35; 33; 37 | — |
| SECONDARY CD19+ B-Cell to CD3+ T-Cell Ratio |
0.04; 0.07; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY CD4+ T-Cell to CD8+ T-Cell Ratio |
1.32; 1.16; 1.20; 1.03; 1.43; 0.96 | — |
| SECONDARY CD4+ Naive T Cell Count |
0.028; 0.013; 0.014; 0.012; 0.032; 0.036 | — |
| SECONDARY CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells |
8; 7; 7; 10; 9; 10 | — |
| SECONDARY CD4+ Central Memory T-Cell (TCM) Count |
0.048; 0.029; 0.027; 0.014; 0.032; 0.032 | — |
| SECONDARY CD4+ TCM Cells as a Percentage of All CD4+ T-Cells |
18; 20; 19; 14; 13; 13 | — |
| SECONDARY CD4+ Effector Memory T-Cell (TEM) Count |
0.161; 0.099; 0.083; 0.051; 0.097; 0.169 | — |
| SECONDARY CD4+ TEM Cells as a Percentage of All CD4+ T-Cells |
41; 39; 36; 46; 34; 39 | — |
| SECONDARY CD8+ Naive T-Cell Count |
0.029; 0.024; 0.010; 0.006; 0.012; 0.019 | — |
| SECONDARY CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells |
10; 12; 9; 8; 8; 6 | — |
| SECONDARY CD8+ TCM Cell Counts |
0.020; 0.014; 0.010; 0.004; 0.007; 0.012 | — |
| SECONDARY CD8+ TCM Cells as a Percentage of All CD8+ T-Cells |
7; 8; 10; 4; 7; 9 | — |
| SECONDARY CD8+ Effector Memory T-Cell (TEM) Count |
0.127; 0.075; 0.065; 0.045; 0.067; 0.135 | — |
| SECONDARY CD8+ TEM Cells as a Percentage of All CD8+ T-Cells |
42; 42; 46; 43; 51; 46 | — |
| SECONDARY CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count |
0.123; 0.072; 0.051; 0.047; 0.058; 0.132 | — |
| SECONDARY CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells |
41; 39; 36; 46; 34; 39 | — |
Summary
The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab is effective and safe in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Eligibility Criteria
Inclusion Criteria
- Patients with Diffuse Large B-Cell Lymphoma (DLBCL) who are refractory to first or later treatment or have a first relapse or later relapse not eligible for autologous hematopoietic stem cell transplant (HSCT) or relapsed post- autologous-HSCT
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age ≥ 18 years
- Life expectancy of ≥ 12 weeks
- Cerebrospinal fluid (CSF) free of infiltration by DLBCL
Exclusion Criteria
- History or presence of clinically relevant central nervous system (CNS) pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis
- Current infiltration of CSF by DLBCL
- History of autoimmune disease with potential CNS involvement or current autoimmune disease
- Autologous HSCT within six weeks prior to start of blinatumomab treatment
- Prior allogeneic HSCT
- Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
- Radiotherapy within four weeks prior to start of blinatumomab treatment
- Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment
- Any investigational anti-lymphoma product within four weeks prior to start of blinatumomab treatment
- Treatment with any other investigational product after signature of informed consent
- Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
- Abnormal laboratory values indicative of inadequate renal or liver function
- History of malignancy other than non-Hodgkin's lymphoma (NHL) within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
- Active uncontrolled infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus
- Pregnant or nursing women
- Previous treatment with blinatumomab
- Presence of human anti-murine antibodies (HAMA) at screening
Data sourced from ClinicalTrials.gov (NCT01741792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.