A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia

NCT07223190 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 202401132025-523291-23
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with chemotherapy (Arm A) in overall survival (OS) in newly diagnosed participants with Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in complete remission (CR) or CR with incomplete peripheral count recovery (CRi) after induction.

Conditions

Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia

Keywords

Blinatumomab; Lymphoblastic Leukemia; HyperCVAD

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Up to 5 years from randomization

Secondary Outcomes (13)

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

  Up to 5 years from randomization

• Area Under the Concentration-time Curve in Cycle 1 (AUCcycle 1) for SC Blinatumomab

  Up to Cycle 1 Day 35 (Cycle length = 35 days)

• AUCcycle 1 for cIV Blinatumomab

  Up to Cycle 1 Day 35 (Cycle length = 35 days)

• Average Concentration Following Cycle 1 Day 19 Dosing (Cavgd19dose) for SC Blinatumomab

  From predose on Cycle 1 Day 19 to predose on Cycle 1 Day 22 (Cycle length = 35 days)

• Steady-state Concentration (Css) for cIV Blinatumomab

  Up to Cycle 1 Day 29 (Cycle length = 35 days)

Study Arms (2)

HyperCVAD + cIV Blinatumomab in Consolidation

ACTIVE COMPARATOR

Participants with Ph-negative B-ALL will receive cIV blinatumomab infusion for cycles 1, 2, 5 and 6 (each cycle will be 35 days), in conjunction with chemotherapy (HyperCVAD) for cycles 3, 4, 7 and 8 (each cycle will be 2-4 weeks).

Drug: Blinatumomab; Drug: HyperCVAD

HyperCVAD + SC Blinatumomab in Consolidation

EXPERIMENTAL

Participants with Ph-negative B-ALL will receive SC injections of blinatumomab for cycles 1, 2, 5 and 6 (each cycle will be 35 days), in conjunction with chemotherapy (HyperCVAD) for cycles 3, 4, 7 and 8 (each cycle will be 2-4 weeks).

Drug: Blinatumomab; Drug: HyperCVAD

Interventions

Blinatumomab DRUG

Blinatumomab will be administered as a SC injection.

HyperCVAD + SC Blinatumomab in Consolidation

HyperCVAD DRUG

HyperCVAD will administer as the chemo regimen as part of the standard of care (SOC) regimen.

HyperCVAD + SC Blinatumomab in Consolidation; HyperCVAD + cIV Blinatumomab in Consolidation

Eligibility Criteria

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

You may qualify if:

• Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL).
• Age ≥18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2, higher ECOG score allowed if due to underlying leukemia.
• Adequate organ function as described below:
• Renal: estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m\^2 per the Modification of Diet in Renal Disease for adult participants equation
• Hepatic function: total bilirubin ≤3.0 mg/dL prior to start of treatment; unless due to Gilbert's Disease or if liver involvement with leukemia
• Cardiac: left ventricular ejection fraction (LVEF) ≥50% and no clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thromboembolism (VTE) disease.

You may not qualify if:

• Other Medical Conditions
• Isolated extramedullary disease.
• History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis.
• Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
• History of other malignancy within the past 3 years, except for malignancy treated with curative intent with low risk for recurrence. Exceptions include:
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Adequately treated breast ductal carcinoma in situ without evidence of disease.
• Prostatic intraepithelial neoplasia without evidence of prostate cancer.
• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
• Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B or hepatitis C virus.
• Participant with symptoms and/or clinical signs and/or radiographic 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.
• Prior/Concomitant Therapy • Prior cancer chemotherapy/immunotherapy for this newly diagnosed B-ALL before the start of protocol-required therapy with the exception of intrathecal (IT) chemotherapy or pre-phase chemotherapy. Localized radiation for pain or disease control is allowed.
• Prior/Concurrent Clinical Trial Experience
• Currently receiving a trial intervention, or less than 30 days or 5 half-lives if known (whichever is later) since ending a trial intervention in another investigational device or drug trial.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab; CVAD protocol

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; 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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start (Estimated): June 11, 2026
• Primary Completion (Estimated): May 10, 2030
• Study Completion (Estimated): August 9, 2033
• Last Updated: March 4, 2026

Record last verified: 2026-03

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 URL below.