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

ConditionPhiladelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAmgen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Renal: estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m² per the Modification of Diet in Renal Disease for adult participants equation

Disqualifiers

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.

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blinatumomab

    Drug

    Blinatumomab will be administered as a SC injection.

  • Blinatumomab

    Drug

    Blinatumomab will be administered as a cIV infusion.

  • HyperCVAD

    Drug

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

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: HyperCVAD + cIV Blinatumomab in ConsolidationActive comparator 2 interventions
Group B: HyperCVAD + SC Blinatumomab in ConsolidationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to 5 years from randomization

Secondary outcomes

1

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

Number of participants who experience TEAEs, serious TEAEs, treatment-related adverse events, and adverse events of interest.

Time frame
Up to 5 years from randomization
2

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

Time frame
Up to Cycle 1 Day 35 (Cycle length = 35 days)
3

AUCcycle 1 for cIV Blinatumomab

Time frame
Up to Cycle 1 Day 35 (Cycle length = 35 days)
4

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: