Overview

This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma
Treatment blinatumomab
Phase phase 2
Target CD19
Sponsor Amgen Research (Munich) GmbH
Start date July 2012
End date July 2014
Trial size 25 participants
Trial identifier NCT01741792, 2011-005781-38, MT103-208

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
blinatumomab AMG103
continuous intravenous infusion over 8 weeks in the first cycle and 4 weeks in the second cycle

Primary Outcomes

Measure
Overall response rate (ORR)
time frame: within 8 weeks

Secondary Outcomes

Measure
Complete response (CR)
time frame: within 8 weeks
Partial response (PR)
time frame: within 8 weeks
Duration of response (by ORR, CR, and PR)
time frame: within 24 months after first treatment cycle
Progression-free survival (PFS)
time frame: within 24 months after first treatment cycle
Overall survival (OS)
time frame: within 24 months after first treatment cycle
Incidence and severity of adverse events
time frame: up to 28 months
Blinatumomab serum concentration (pharmacokinetics)
time frame: within 8 weeks
Absolute numbers and proportions of lymphocyte subpopulations
time frame: up to 28 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Sample size: 25 evaluable patients Study population 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 auto- HSCT or relapsed post- autologous-HSCT - 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 CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis - Current infiltration of cerebro-spinal fluid (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 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 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

Additional Information

Official title An Open Label, Multicenter, Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE) Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Description DLBCL is an aggressive malignant disease which evolves from B-cells and affects mainly the lymphatic tissue. Due to its aggressive nature the disease is characterized by a fast course which is lethal without therapy. Potentially curative therapy options are available even at advanced stages. Standard-first line leads to a high initial response rate (85-90%) and an approximate cure rate of 50% of patients. Patients refractory to or with early relapse after this treatment (10-15%) have a very poor prognosis. Blinatumomab is a bispecific single-chain antibody derivative against CD19 and CD3, designed to link B-cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against CD19 expressing cells. In vitro data indicate CD19+ lymphoma and leukemia cell lines to be extremely sensitive to blinatumomab-mediated cytotoxicity. A phase 1 study (MT103-104) has indicated dose-dependent efficacy and acceptable tolerability of blinatumomab in patients with relapsed B-cell Non-Hodgkin's Lymphoma (B-NHL). The purpose of this study is to confirm wether the bispecific T-cell engager blinatumomab is effective and safe in the treatment of patients with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL). The patients will be treated with 2 different dosing schedules of continuous intravenous blinatumomab treatment . Patients will receive up to 2 cycles (first cycle 8 weeks, second cycle 4 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Amgen Research (Munich) GmbH.