NCT00274742

Brief Summary

The purpose of this study is to determine whether a continuous infusion of Blinatumomab (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma. Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of Blinatumomab as well as to get first indication of tumour activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

7.2 years

First QC Date

January 10, 2006

Results QC Date

December 23, 2014

Last Update Submit

January 15, 2015

Conditions

Non-Hodgkin's Lymphoma, Relapsed

Keywords

Non-Hodgkin's LymphomaCancer immunotherapyMonoclonal antibodyanti-CD19anti-CD3BiTEBlinatumomab

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events

    From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days.

Secondary Outcomes (3)

  • Serum Concentration of Blinatumomab

    Up to 24 hours after the end of infusion.

  • Objective Tumor Response According to the Cheson Criteria (Without Minimal Response)

    Assessed after 4 and 8 weeks of treatment

  • Objective Tumor Response According to the Cheson Criteria (With Minimal Response)

    Assessed after 4 and 8 weeks of treatment

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Patients received blinatumomab as continuous intravenous infusion for 4 weeks. Participants with clinical benefit were permitted to continue for another 4 weeks for a total of 8 weeks. Participants with a clinical benefit 4 weeks after completion of the first cycle of treatment could also receive additional treatment approximately 3 months ater the end of infusion at the same dose level.

Biological: Blinatumomab (MT103)

Interventions

Blinatumomab (MT103)BIOLOGICAL

Doses from 0.5 to 120 µg/m\^2/24hours by continuous intravenous infusion

Also known as: Blinatumomab, MT103, AMG103, BLINCYTO™
Blinatumomab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with first or later relapse of histologically (World Health Organisation classification) confirmed:
  • follicular lymphoma (grade I/II)
  • marginal zone lymphoma
  • lymphoplasmocytic lymphoma
  • mantle cell lymphoma
  • diffuse large B-cell lymphoma
  • small lymphocytic lymphoma requiring therapy and not eligible for curative treatment
  • Measurable disease (at least one lesion \>= 1.5 cm) documented by computed tomography (CT) scan
  • Age \>= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status \<=2
  • Life expectancy of at least 6 months
  • Ability to understand the patient information and informed consent form
  • Signed and dated written informed consent is available
  • B:T cell ratio (Fluorescence-Activated Cell Sorter \[FACS\] analysis results by central lab) available before study entry.

You may not qualify if:

  • Abnormal laboratory values as defined below:
  • Peripheral lymphocyte count \> 20 x 10\^9/L
  • Platelet counts ≤ 75,000/µL
  • Hemoglobin level ≤ 9 g/dL
  • Venous pH value out of normal range or oxygen saturation ≤ 90%
  • Known or suspected central nervous system (CNS) involvement by NHL
  • a)History of or current relevant CNS pathology as epilepsy, seizure, paresis,aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis b)Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI
  • Autologous stem cell transplantation within 12 weeks prior to study entry
  • Allogeneic stem cell transplantation
  • Cancer chemotherapy within 4 weeks prior to study entry
  • Radiotherapy within 4 weeks prior to study entry
  • Treatment with rituximab within 4 weeks prior to study entry
  • Prior treatment with alemtuzumab 12 weeks prior to study entry
  • Treatment with any investigational agent within 12 weeks prior to study entry
  • Contraindication for any of the concomitant medications
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medizinische Klinik 5, Hämatologie & Internistische Onkologie, Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen, Klinik für Hämatologie, Medizinische Klinik und Poliklinik

Essen, 45147, Germany

Location

Universtätsklinkum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm, Abteilung Innere Medizin III

Ulm, 89081, Germany

Location

Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg

Würzburg, 97080, Germany

Location

Related Publications (2)

  • Nagele V, Zugmaier G, Goebeler ME, Viardot A, Bargou R, Kufer P, Klinger M. Relationship of T- and B-cell kinetics to clinical response in patients with relapsed/refractory non-Hodgkin lymphoma treated with blinatumomab. Exp Hematol. 2021 Aug;100:32-36. doi: 10.1016/j.exphem.2021.06.005. Epub 2021 Jul 3.

    PMID: 34228983DERIVED

  • 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: 27209293DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinRecurrenceBites and Stings

Interventions

blinatumomabN,N-dicyclohexyl-isoborneol-10-sulfonamide

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • Ralf Bargou, MD, PhD

    Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg, Zentrum für Innere Medizin, Oberdürrbacherstr. 6 D-97080 Würzburg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

June 1, 2004

Primary Completion

August 1, 2011

Study Completion

April 1, 2012

Last Updated

January 16, 2015

Results First Posted

January 16, 2015

Record last verified: 2015-01

Locations

DE(5)