A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

NCT04521231 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 201802572023-506136-32
• Study Type: interventional
• Target: 281
• Locations: 18 countries
• Sites: 101

Brief Summary

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.

Conditions

B Cell Precursor Acute Lymphoblastic Leukemia

Keywords

R/R B-ALL; MRD+ B-ALL; Relapsed; Refractory; Minimal Residual Disease; AMG 103; Blinatumomab; Acute lymphoblastic leukemia; Adolescent; Adult

Outcome Measures

Primary Outcomes (11)

• Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)

  Up to 29 days

• Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

  Up to approximately 28 weeks

• Dose Escalation Phase: Number of participants who experience one or more serious TEAEs

  Up to approximately 28 weeks

• Dose Escalation Phase: Number of participants who experience one or more treatment-related TEAEs

  Up to approximately 28 weeks

• Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) of Interest (AEIs)

  Up to approximately 28 weeks

• Dose Expansion and Phase 2 Ph-IIR cohort: Number of participants who achieve complete remission (CR) / complete remission with partial hematological recovery (CRh)

  Up to 10 weeks

• Phase 2 Ph-IIC cohort: Maximum concentration (Cmax) of blinatumomab SC1 and SC2

  Up to approximately 4 weeks

• Phase 2 Ph-IIC cohort: Average concentration (Cavg) of blinatumomab SC1 and SC2

  Up to approximately 4 weeks

• Phase 2 Ph-IIC cohort: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2

  Up to approximately 4 weeks

• Phase 2 Ph-IIC cohort: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2

  Up to approximately 4 weeks

• Phase 2 Ph-IIM cohort: Number of participants who achieve CR with MRD-negative response

  Up to 10 weeks

Secondary Outcomes (28)

• Dose Escalation and Dose Expansion Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab

  Up to approximately 10 weeks

• Dose Escalation and Dose Expansion Phase: Cmax of blinatumomab

  Up to approximately 10 weeks

• Dose Escalation and Dose Expansion Phase: Tmax of blinatumomab

  Up to approximately 10 weeks

• Dose Escalation and Dose Expansion Phase: AUC of blinatumomab

  Up to approximately 10 weeks

• Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh

  Up to 10 weeks

Study Arms (5)

Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)

EXPERIMENTAL

Cohorts of at least 3 adult participants with R/R B-ALL will be treated with escalating doses of blinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.

Drug: Blinatumomab

Dose Expansion Phase: Blinatumomab SC1

EXPERIMENTAL

Up to 4 cohorts of adult participants with R/R B-ALL will be enrolled at different dose levels to support identification of the RP2D. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.

Drug: Blinatumomab

Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations

EXPERIMENTAL

1 cohort of adult participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the preliminary RP2D determined from the dose expansion phase, in participants with R/R B-ALL.

Drug: Blinatumomab

Ph-IIR: Efficacy of SC Blinatumomab in Participants with R/R B-ALL

EXPERIMENTAL

The efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with R/R B-ALL.

Drug: Blinatumomab

Ph-IIM: Efficacy of SC Blinatumomab in Participants with MRD+ B-ALL

EXPERIMENTAL

The efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with MRD+ B-ALL.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Blinatumomab will be administered as a subcutaneous (SC) injection.

Also known as: AMG 103

Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1); Dose Expansion Phase: Blinatumomab SC1; Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations; Ph-IIM: Efficacy of SC Blinatumomab in Participants with MRD+ B-ALL; Ph-IIR: Efficacy of SC Blinatumomab in Participants with R/R B-ALL

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ph-IIC, Dose Escalation and Dose Expansion: Aged 18 years or older (or same or greater than legal age within the country if it is older than 18 years).
• Ph-IIRa and Ph-IIMa: Aged ≥ 17 years at time of informed consent.
• Ph-IIRb and Ph-IIMb: Age ≥ 12 years and \< 17 years at time of informed consent.
• Ph-IIR, Ph-IIC, Dose escalation, Dose Expansion: Participants with R/R B-precursor ALL.
• Relapsed or Refractory B-precursor ALL at any time after first salvage therapy.
• Relapsed B-precursor ALL at any time after allogenic hematopoietic stem cell transplant (HSCT).
• Ph-IIR, Ph-IIC, Dose escalation, Dose expansion: Greater than or equal to 5% blasts in the Bone Marrow per local assessment.
• Ph-IIM: B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and \< 5% per local assessment.
• Ph-IIM: Availability of an appropriate archival BM specimen from initial or relapse diagnosis and the screening BM sample.
• Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
• Participants aged 16 to \< 18 years old: Karnofsky Performance Score ≥ 50%.
• Participants aged \< 16 years old: Lansky Performance Score ≥ 50%.
• Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
• Ph-IIM: BM function as follows:
• Absolute Neutrophil Count (ANC) ≥ 500/μL

You may not qualify if:

• Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia. If CSF leukemia is present subjects will have to receive intrathecal therapy and have documented negative CSF prior to enrolling.
• History or presence of clinically relevant CNS pathology (excluding headache) such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including immune effector cell-associated neurotoxicity syndrome (ICANS) from prior chimeric antigen receptor T-cell (CAR T) or other T cell engager therapies.
• Isolated Extramedullary (EM) Disease.
• For Ph-IIM only: Current EM disease or presence of circulating leukemia blasts.
• Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
• Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication.
• Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any other disease or condition that could be exacerbated by the treatment or would complicate protocol compliance.
• Testicular leukemia.
• History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy.
• Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy.
• Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions).
• Immunotherapy within 4 weeks before start of protocol-specified therapy.
• Prior failed cluster of differentiation (CD19) directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed (with demonstrated continued CD19+ expression), if treatment ended more than 4 weeks prior to start of protocol therapy and no prior CNS complications.
• Currently receiving treatment in or less than 30 days or 5 half-lives since ending treatment on another investigational study(ies).
• Abnormal screening laboratory parameters.

Sponsors & Collaborators

• Amgen: lead
• BeOne Medicines: collaborator

Study Sites (109)

University of California San Francisco Fresno at Community Cancer Institute

Clovis, California, 93611, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

C.S. Mott Children's Hospital - University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

New York University Grossman School of Medicine and New York University Langone Hospitals

New York, New York, 10016, United States

RECRUITING

Albert Einstein College of Medicine - Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

St Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109-1023, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109-1023, United States

COMPLETED

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

RECRUITING

Sanatorio Allende

Córdoba, Córdoba Province, X5000JHQ, Argentina

RECRUITING

Instituto Alexander Fleming

Buenos Aires, C1426ANZ, Argentina

RECRUITING

Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno

Ciudad Autonoma Buenos Aires, C1431FWO, Argentina

RECRUITING

Sydney Childrens Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Queensland Childrens Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Austin Health, Austin Hospital

Heidelberg, Victoria, 3084, Australia

TERMINATED

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Perth Childrens Hospital

Nedlands, Western Australia, 6909, Australia

RECRUITING

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

COMPLETED

Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne

Yvoir, 5530, Belgium

RECRUITING

Hospital Sirio Libanes Brasilia

Brasília, Federal District, 70200-730, Brazil

RECRUITING

Instituto Medicina Integral Imip

Recife, Pernambuco, 50070-902, Brazil

RECRUITING

Hosp de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Fundacao Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

RECRUITING

Hosp Clin Fac Med Ribeirao Preto Usp

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Instituto Onco Ped Graac Unifesp

São Paulo, São Paulo, 04039-001, Brazil

RECRUITING

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2P4, Canada

RECRUITING

Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Beijing Childrens Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Zhujiang Hospital of Southern Medical Unversity

Guangzhou, Guangdong, 510280, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215002, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215031, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

The First Affiliated Hospital Of Xi'An Jiaotong Unversity

Xi’an, Shanxi, 710061, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

The Childrens Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310005, China

RECRUITING

Centre Hospitalier de Versailles - Hopital Andre Mignot

Le Chesnay, 78157, France

RECRUITING

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

Lille, 59000, France

RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital de l Archet

Nice, 06202, France

RECRUITING

Hopital Saint Louis

Paris, 75010, France

RECRUITING

Hopital Saint Antoine

Paris, 75012, France

RECRUITING

Hopital Robert Debre

Paris, 75019, France

RECRUITING

Hopital Lyon Sud

Pierre-Bénite, 69645, France

RECRUITING

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31059, France

RECRUITING

Universitaetsklinikum Augsburg

Augsburg, 86156, Germany

RECRUITING

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

Charite - Universitaetsmedizin Berlin, Campus Virchow

Berlin, 13353, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, 50937, Germany

RECRUITING

Universitaetsklinikum Jena

Jena, 07747, Germany

RECRUITING

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

COMPLETED

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

RECRUITING

Universitatsklinikum Ulm

Ulm, 89081, Germany

COMPLETED

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Hong Kong Childrens Hospital

Kowloon Bay, Hong Kong

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

RECRUITING

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4941492, Israel

RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

Bergamo, 24127, Italy

RECRUITING

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

Bologna, 40138, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico

Catania, 95123, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

COMPLETED

Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

Naples, 80123, Italy

RECRUITING

Azienda Ospedaliera Policlinico Umberto I

Roma, 00161, Italy

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

RECRUITING

Akita University Hospital

Akita, Akita, 010-8543, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

RECRUITING

Kanagawa Childrens Medical Center

Yokohami-shi, Kanagawa, 232-8555, Japan

RECRUITING

Erasmus Medisch Centrum

Rotterdam, 3015 CN, Netherlands

RECRUITING

Prinses Maxima Centrum

Utrecht, 3584 CS, Netherlands

RECRUITING

Institutul Oncologic Prof Dr Ion Chiricuta

Cluj-Napoca, 400015, Romania

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 58128, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

COMPLETED

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

RECRUITING

Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Sant Joan de Deu

Esplugues de Llobregat, Catalonia, 08950, Spain

RECRUITING

Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

L'Hospitalet de Llobregat, Catalonia, 08908, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Hospital Universitario Infantil Niño Jesus

Madrid, 28009, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Istanbul Florence Nightingale Hastanesi

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, 35575, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Jabbour E, Zugmaier G, Agrawal V, Martinez-Sanchez P, Rifon Roca JJ, Cassaday RD, Boll B, Rijneveld A, Abdul-Hay M, Huguet F, Cluzeau T, Diaz MT, Vucinic V, Gonzalez-Campos J, Rambaldi A, Schwartz S, Berthon C, Hernandez-Rivas JM, Gordon PR, Bruggemann M, Hamidi A, Chen Y, Wong HL, Panwar B, Katlinskaya Y, Markovic A, Kantarjian H. Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia. Am J Hematol. 2024 Apr;99(4):586-595. doi: 10.1002/ajh.27227. Epub 2024 Feb 5.

  PMID: 38317420 BACKGROUND

• Jabbour E, Lussana F, Martinez-Sanchez P, Torrent A, Rifon JJ, Agrawal V, Tormo M, Cassaday RD, Cluzeau T, Huguet F, Papayannidis C, Hernandez-Rivas JM, Rijneveld A, Fleming S, Vucinic V, Boll B, Ikezoe T, Abdul-Hay M, Savoie ML, Schuh AC, Berthon C, Schwartz S, Chiaretti S, Yuda J, Miyazaki T, Gonzalez-Campos J, Chen Y, Wong H, Choudhry J, Zugmaier G, Guest E, Gordon P, Kantarjian H. Subcutaneous blinatumomab in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: post-hoc safety and activity analysis from a multicentre, single-arm, phase 1/2 trial. Lancet Haematol. 2025 Jul;12(7):e529-e541. doi: 10.1016/S2352-3026(25)00144-9. Epub 2025 Jun 15.

  PMID: 40532723 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Recurrence; Neoplasm, Residual; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: January 4, 2021
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): May 25, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL below.

Locations

BR (6); TU (5); CA (5); AU (1); HK (2); BE (1); AR (4); ES (11); RO (1); US (14); KR (3); NL (2); CN (14); JP (5); DE (9); FR (8); IT (8); IL (2)