Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

NCT01741792 | Completed Phase 2 Results DMC

• 2 other identifiers: MT103-2082011-005781-38
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Relapsed DLBCL; Refractory DLBCL; adult DLBCL; Lymphoma; Non-Hodgkin Lymphoma; Lymphatic diseases; Lymphoproliferative disorders; bispecific antibody; anti-CD19; Immunotherapeutic treatment; Immunoproliferative disorders

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response Rate During Treatment Cycle 1

  Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites.

  During the first 8 weeks

Secondary Outcomes (37)

• Percentage of Participants With a Best Overall Response of Complete Response

  During the first 8 weeks

• Percentage of Participants With a Best Overall Response of Partial Response

  During the first 8 weeks

• Duration of Objective Response

  From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.

• Duration of Complete Response

  From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.

• Duration of Partial Response

  From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.

Study Arms (1)

Blinatumomab

EXPERIMENTAL

By study design, two dose regimens were assessed in this study. In Stage 1, Cohort 1, participants received blinatumomab in a dose-escalating manner: 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during cycle 1. In Cohort 2, the next participants enrolled and received a constant dose of 112 µg/day blinatumomab. The dosing regimen with the more favorable benefit-risk profile was then selected for Stage 2, Cohort 3.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Administered by continuous intravenous infusion over 8 weeks in the first cycle and 4 weeks in the second cycle.

Also known as: AMG103, MT103, BLINCYTO®

Blinatumomab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen Research (Munich) GmbH: lead

Study Sites (6)

Universitätsmedizin

Göttingen, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Germany

Location

Universitätsklinikum Schleswig Holstein

Kiel, Germany

Location

Klinikum der Johannes-Gutenberg Universität

Mainz, Germany

Location

Universitätsklinikum

Ulm, Germany

Location

Universititätsklinikum

Würzburg, Germany

Location

Related Publications (2)

• Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

  PMID: 27209293 DERIVED

• Viardot A, Goebeler ME, Hess G, Neumann S, Pfreundschuh M, Adrian N, Zettl F, Libicher M, Sayehli C, Stieglmaier J, Zhang A, Nagorsen D, Bargou RC. Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6. doi: 10.1182/blood-2015-06-651380. Epub 2016 Jan 11.

  PMID: 26755709 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma; Lymphoma, Non-Hodgkin; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen, Inc.

866-572-6436

Study Officials

• - MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 5, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2015
• Last Updated: January 6, 2017
• Results First Posted: July 27, 2015

Record last verified: 2016-11

Locations

DE (6)