Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

NCT06054113 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20190359
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective of this study is to evaluate the efficacy of blinatumomab.

Conditions

B Precursor Acute Lymphoblastic Leukemia; Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia

Keywords

Relapsed/Refractory B precursor Acute Lymphoblastic Leukemia; R/R B-ALL; Blinatumomab

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Complete Remission (CR)

  Up to 84 days

• Number of Participants with CR with Partial Recovery of Peripheral Blood Counts (CRh)

  Up to 84 days

Secondary Outcomes (12)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to approximately 240 days

• Number of Participants with Serious TEAEs

  Up to approximately 2 years

• Number of Participants with Treatment-related TEAEs

  Up to approximately 240 days

• Number of Participants with Adverse Events of Interest

  Up to approximately 240 days

• Steady State Concentration (Css) of Blinatumomab

  Days 3, 8, 9 and 29

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Participants will receive up to 5 cycles of blinatumomab (cycle is 42 days), including a 28-day continuous intravenous infusion (CIVI) of blinatumomab and a 14-day treatment free interval.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Administered via CIVI

Also known as: Blincyto®

Blinatumomab

Eligibility Criteria

• Age: 1 Month - 204 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participant's parent or legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated
• Pediatric participants aged \> 1 month and \< 18 years at the time of informed consent
• Relapsed or/refractory precursor B-cell acute lymphoblastic leukemia (ALL) disease, defined as ≥5% bone marrow blasts with at least one of the following:
• Second or later bone marrow relapse;
• Any marrow relapse after allogeneic hematopoietic stem cell transplant (alloHSCT);
• Refractory to other treatments:
• For participants in first relapse: failure to achieve a complete remission (CR) following a full standard reinduction chemotherapy regimen
• For participants who have not achieved a first remission, failure to achieve remission following a full standard induction regimen
• Karnofsky performance status ≥ 50% for participants ≥ 16 years
• Lansky performance status ≥ 50% for participants \< 16 years

You may not qualify if:

• \- Evidence of current central nervous system (CNS) involvement by ALL. Participants with CNS disease at the time of relapse are eligible if CNS is successfully treated prior to enrollment.
• Other Medical Conditions
• Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy).
• Isolated extramedullary (EM) disease.
• Active malignancy other than ALL.
• Burkitt's leukemia according to the World Health Organization (WHO) 2016 criteria.
• Abnormal renal or hepatic function at screening as defined below:
• Abnormal serum creatinine based on age/gender as described by Threshold Creatinine Values
• Direct bilirubin \> 1.5 mg/dl (25.6 μmol/L) at screening (unless related to Gilbert's or Meulengracht disease).
• Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol.
• Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (hepatitis B surface antigen \[HBsAg\] positive) or hepatitis C virus (HCV) (anti-HCV positive).
• Known hypersensitivity to blinatumomab or any of the products or components of the blinatumomab formulation.
• Prior/Concomitant Therapy
• AlloHSCT within 12 weeks prior to start of protocol-specified therapy.
• Active acute or chronic Graft-versus-Host-Disease (GvHD) requiring systemic treatment with immunosuppressive medication.

Sponsors & Collaborators

• Amgen: lead

Study Sites (7)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Childrens Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400015, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Wuhan Childrens Hospital

Wuhan, Hubei, 430015, China

Location

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215002, China

Location

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

Location

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

Tianjin, Tianjin Municipality, 300020, China

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Recurrence

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

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 18, 2023
• First Posted: September 26, 2023
• Study Start: July 23, 2024
• Primary Completion: January 5, 2026
• Study Completion (Estimated): October 14, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

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

CN (7)