Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

NCT ID: NCT01209286

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-10-31

Brief Summary

The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab is effective, safe and tolerable in the treatment of patients with relapsed/refractory B-precursor ALL.

Detailed Description

Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis and unmet medical need. Additional therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. The purpose of this study is to investigate the efficacy, safety and tolerability of different doses of the bispecific T-cell engager blinatumomab in adult patients with relapsed/refractory B-precursor ALL. Patrticipants will receive up to five 4-week cycles of intravenous blinatumomab treatment.

Conditions

B-ALL

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blinatumomab 15 μg

Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.

Group Type: EXPERIMENTAL

Blinatumomab

Intervention Type: BIOLOGICAL

Continuous intravenous infusion over four weeks per treatment cycle

Blinatumomab 5/15 μg

Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.

Group Type: EXPERIMENTAL

Blinatumomab

Intervention Type: BIOLOGICAL

Continuous intravenous infusion over four weeks per treatment cycle

Blinatumomab 5/15/30 μg

Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.

Group Type: EXPERIMENTAL

Blinatumomab

Intervention Type: BIOLOGICAL

Continuous intravenous infusion over four weeks per treatment cycle

Interventions

Blinatumomab

Continuous intravenous infusion over four weeks per treatment cycle

Intervention Type: BIOLOGICAL

Other Intervention Names

AMG103; MT103; BLINCYTO™

Eligibility Criteria

Inclusion Criteria

• Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
• More than 5% blasts in bone marrow
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Life expectancy of ≥ 12 weeks

Exclusion Criteria

• History or presence of clinically relevant central nervous system (CNS) pathology
• Infiltration of cerebrospinal fluid (CSF) by ALL
• Autologous/allogeneic hematopoietic stem cell transplantation (HSCT) within six weeks/three months prior to start of blinatumomab treatment
• Active Graft-versus-Host Disease (GvHD)
• Patients with Philadelphia chromosome (Ph)+ ALL eligible for treatment with dasatinib or imatinib
• Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
• Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
• Infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
• Pregnant or nursing women
• Previous treatment with blinatumomab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen Research (Munich) GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Max Topp, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wuerzburg

Locations

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Hanover, , Germany

Kiel, , Germany

Münster, , Germany

Regensburg, , Germany

Tübingen, , Germany

Ulm, , Germany

Würzburg, , Germany

Countries

Germany

References

Nagele V, Kratzer A, Zugmaier G, Holland C, Hijazi Y, Topp MS, Gokbuget N, Baeuerle PA, Kufer P, Wolf A, Klinger M. Changes in clinical laboratory parameters and pharmacodynamic markers in response to blinatumomab treatment of patients with relapsed/refractory ALL. Exp Hematol Oncol. 2017 May 18;6:14. doi: 10.1186/s40164-017-0074-5. eCollection 2017.

Reference Type: DERIVED

PMID: 28533941 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27209293 (View on PubMed)

Topp MS, Gokbuget N, Zugmaier G, Klappers P, Stelljes M, Neumann S, Viardot A, Marks R, Diedrich H, Faul C, Reichle A, Horst HA, Bruggemann M, Wessiepe D, Holland C, Alekar S, Mergen N, Einsele H, Hoelzer D, Bargou RC. Phase II trial of the anti-CD19 bispecific T cell-engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia. J Clin Oncol. 2014 Dec 20;32(36):4134-40. doi: 10.1200/JCO.2014.56.3247. Epub 2014 Nov 10.

Reference Type: DERIVED

PMID: 25385737 (View on PubMed)

Other Identifiers

MT103-206

Identifier Type: -

Identifier Source: org_study_id