Effect of Blinatumomab on Minimal Residual Disease (MRD) in Diffuse Large B-Cell Lymphoma (DLBCL) Subjects Post Autologous Hematopoietic Stem Cell Transplantation (aHSCT)

NCT03298412 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 201502912016-003255-30
• Study Type: interventional
• Target: 10
• Locations: 7 countries
• Sites: 32

Brief Summary

The study will estimate the MRD-negative response rate after treatment with blinatumomab in subjects with high-risk DLBCL who are MRD-positive following aHSCT. The clinical hypothesis is that the MRD-negative response rate will be greater than 10%. Achieving an MRD-negative response rate of 30% would be of scientific and clinical interest.

Conditions

High-risk Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• MRD-Negative Rate at the End of Cycle 1

  The estimated MRD-negative rate, calculated as the percentage of participants with MRD-negative status after treatment with blinatumomab. MRD-negative status was assessed by positron emission tomography-computed tomography (PET-CT) or computed tomography (CT).

  12 weeks (84 days)

Secondary Outcomes (4)

• Kaplan-Meier Estimate: Progression-Free Survival (PFS)

  up to 1 year from first dose of blinatumomab

• Kaplan-Meier Estimate: Duration of MRD-Negative Status

  up to 1 year from first dose of blinatumomab

• Kaplan-Meier Estimate: Overall Survival (OS)

  up to 1 year from first dose of blinatumomab

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From first dose of study drug through 30 days after the last dose of study drug. The treatment duration for the participant who received blinatumomab was 57 days.

Study Arms (1)

Blinatumomab

EXPERIMENTAL

After a run-in period of up to 24 months to evaluate MRD status and assess eligibility for treatment assignment, participants received blinatumomab intravenous (IV) infusion at an initial dose of 9 μg/day for the first 7 days of treatment, escalated (dose-step) to 28 μg/day starting on Day 8 (Week 2), followed by a dose-step to 112 μg/day starting on Day 15 (Week 3) and continuing until completion of therapy (Day 57 of Cycle 1). Cycle 1 of blinatumomab treatment is 12 weeks (84 days) in duration and includes 8 weeks (56 days) of blinatumomab IV infusion followed by a 4-week (28-day) treatment-free interval.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Blinatumomab is administered as a continuous IV infusion.

Also known as: BLINCYTO, AMG 103

Blinatumomab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subject has provided informed consent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
• Age ≥ 18 at time of informed consent
• Biopsy-proven DLBCL excluding DLBCL that represents transformation of indolent non-Hodgkin's lymphoma (NHL) Note: Lymphoblastic Lymphoma and Burkitt Lymphoma histology are not eligible
• Subject has ≥ 1 characteristic feature of high-risk DLBCL:
• High-risk first complete remission (defined as interim positron emission tomography - computed tomography (PET-CT) positive or \< complete remission to frontline chemotherapy AND achieved complete remission to platinum-containing salvage)
• Relapse within 1 year of diagnosis
• Secondary age-adjusted international prognostic index \> 1
• Partial response/partial metabolic response after minimum of 2 cycles of platinum-containing salvage chemotherapy
• C-myc rearrangement
• aHSCT with high-dose chemotherapy following first (or later) salvage treatment.
• PET-CT negative (Deauville score ≤ 3) 90 days (± 30 days) post aHSCT
• Available relapsed and/or diagnostic pathology formalin-fixed paraffin-embedded (FFPE) tumor block or slide samples at the time of enrollment including the successful identification of malignant clone sequences by the central laboratory.
• MRD plasma sample collected ≤ 3 weeks after the post aHSCT PET-CT scan
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate organ function determined ≤ 3 weeks prior to enrollment defined as follows:

Sponsors & Collaborators

• Amgen: lead

Study Sites (32)

Research Site

Atlanta, Georgia, 30342, United States

Location

Research Site

Maywood, Illinois, 60153, United States

Location

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Cleveland, Ohio, 44195, United States

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Dallas, Texas, 75246, United States

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St Leonards, New South Wales, 2065, Australia

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Westmead, New South Wales, 2145, Australia

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Clayton, Victoria, 3168, Australia

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Geelong, Victoria, 3220, Australia

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Charleroi, 6000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Créteil, 94010, France

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Lille, 59037, France

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Marseille, 13009, France

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Montpellier, 34295, France

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Paris, 75475, France

Location

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Pessac, 33604, France

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Pierre-Bénite, 69495, France

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Rouen, 76038, France

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Athens, 10676, Greece

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Athens, 11527, Greece

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Thessaloniki, 57010, Greece

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Bergamo, 24127, Italy

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Brescia, 25123, Italy

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Florence, 50134, Italy

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Milan, 20162, Italy

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Palermo, 90146, Italy

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Torino, 10126, Italy

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Bellinzona, 6500, Switzerland

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Bern, 3010, Switzerland

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Lausanne, 1011, Switzerland

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Zurich, 8091, Switzerland

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

blinatumomab

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

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: September 12, 2017
• First Posted: October 2, 2017
• Study Start: May 23, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: September 11, 2020
• Results First Posted: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

AU (4); BE (3); FR (8); GR (3); US (4); IT (6); CH (4)