Recruiting

Subcutaneous Blinatumomab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Study Aim

This study aims to evaluate the safety, tolerability, and effectiveness of subcutaneous Blinatumomab in adults with relapsed or refractory B-Cell Acute Lymphoblastic Leukemia, focusing on finding the best dose and observing how the body responds.

What is being tested

Blinatumomab

Drug

Who is being recruted

Hematologic Diseases+14

+ Hemic and Lymphatic Diseases

+ Immune System Diseases

Over 12 Years

+33 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: January 2021

See protocol details

Summary

Principal SponsorAmgen

Study ContactAmgen Call Center

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 4, 2021

Actual date on which the first participant was enrolled.

This clinical trial is focused on studying a specific medication called blinatumomab, which is used in treating a type of blood cancer known as B cell precursor acute lymphoblastic leukemia (B-ALL). The study involves participants who have either relapsed or have forms of the disease that haven't responded to prior treatments. It also includes those who have minimal residual disease, meaning small amounts of cancer cells remain after treatment. The aim is to assess the safety and effectiveness of giving this medication through an injection under the skin, which could potentially offer a more convenient and effective treatment option for patients aged 12 and older. Participants in the study receive the medication blinatumomab through subcutaneous injections. Researchers are working to determine the safest and most effective dosage. They are closely monitoring participants for any side effects, including serious ones, to ensure the treatment's safety and tolerability. The study also measures how well participants respond to the treatment, looking for signs of complete remission or reduction of cancer cells. Additionally, researchers are studying how the body processes the medication through various measurements like concentration levels in the blood. This could lead to better treatment strategies for people dealing with this challenging form of leukemia.

Official TitleA Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL

NCT04521231

Principal SponsorAmgen

Study ContactAmgen Call Center

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

281 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesRecurrencePathological Conditions, Signs and SymptomsNeoplasm, ResidualDisease AttributesPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

17 inclusion criteria required to participate

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.

Greater than or equal to 5% blasts in the Bone Marrow per local assessment.

B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and < 5% per local assessment.

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16 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Group IV

Experimental

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

Group 5

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 73 locations

Recruiting

City of Hope National Medical Center

Duarte, United StatesOpen City of Hope National Medical Center in Google Maps

Recruiting

University of Illinois Chicago

Chicago, United States

Recruiting

Johns Hopkins University

Baltimore, United States

Recruiting

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

Ann Arbor, United States

Recruiting

73 Study Centers