A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

Amgen

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia; Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia

Treatments: Drug: Blinatumomab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07134088

20220107

Details and patient eligibility

About

The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.

Enrollment: 104 estimated patients

Sex: All

Ages: 28 to 4383 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥28 days to <12 years at the time of informed consent/assent.

• Lansky Performance Status (LPS) of ≥ 50%.

• For Phase 1b and Phase 2 cohort in participants with R/R B-ALL:

  • Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic hematopoietic stem cell transplant (HSCT).
  • Greater than or equal to 5% blasts in the bone marrow (BM) is considered as relapse in the BM.

• For Phase 2 cohort in participants with MRD+ B-ALL:

  • Participants with MRD+ B-ALL must have between ≥ 0.1% and < 5% blasts in the BM.

• Prior CD19-directed therapy will be allowed (with demonstrated continued CD19+ expression) if treatment ended >4 weeks prior to start of protocol therapy and no prior central nervous system (CNS) complications.

• Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

Exclusion criteria

• Active ALL in the CNS.
• History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or severe (≥ grade 3) CNS events including immune effector cell-associated neurologic syndrome (ICANS) from prior CAR-T or other T-cell engager therapies.
• Isolated EM disease.
• Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
• Patients with Down Syndrome are not eligible for this study.
• Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication.
• Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.
• Presence of an acute or uncontrolled chronic infection, or any other concurrent disease or medical condition that could be worsened by the treatment or interfere with the participant's ability to comply with the study protocol.
• Allogeneic HSCT within 12 weeks before the start of blinatumomab.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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104 participants in 3 patient groups

Phase 1b: R/R B-ALL

Experimental group

Description:

Participants with R/R B-ALL will receive blinatumomab as SC injection to determine the pediatric recommended Phase 2 dose (RP2D).

Treatment:

Drug: Blinatumomab

Cohort Ph2-R

Experimental group

Description:

Participants with R/R B-ALL will receive blinatumomab as SC injection at RP2D.

Treatment:

Drug: Blinatumomab

Cohort Ph2-M

Experimental group

Description:

Participants with MRD+ B-ALL will receive blinatumomab as SC injection at RP2D.

Treatment:

Drug: Blinatumomab