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A phase 1/2 study of subcutaneous blinatumomab administration in children with R/R and MRD+ B-ALL
EU CTIS ID: 2025-521671-31-00
What this study is testing
Phase 1b: To evaluate the safety and tolerability of SC blinatumomab in children below 12 years of age Phase 2 Cohort Ph2-R & M: To evaluate the efficacy of SC blinatumomab
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant’s 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 before any study-specific activities/procedures being initiated.
- Age 28 days to < 12 years at the time of consent
- Lansky Performance Status (LPS) of ≥ 50%
- Prior CD19-directed therapy such as blinatumomab or CD19 chimeric antigen receptor T cells (CAR-T) cells 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 (see CNS exclusion criteria below).
- Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
- For Phase 1b and Phase 2 cohort in participants with R/R B-ALL (Ph2-R): Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic HSCT Refractory disease is defined as the failure to achieve CR. Relapsed disease is defined as isolated hematological relapse or combined hematological and extramedullary (EM) relapse after achieving a CR. Greater than or equal to 5% blasts in the BM is considered as relapse in the BM.
You likely can't join if
- Disease Related: Active ALL in the CNS. If CSF leukemia is present, participants must receive intrathecal therapy and have documented negative CSF prior to enrolling.
- Prior/Concomitant Therapy: 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
- Prior/Concomitant Therapy: Allogeneic HSCT within 12 weeks before the start of blinatumomab
- Prior/Concomitant Therapy: Cancer chemotherapy within 2 weeks before the start of protocol specified therapy, with the exception of intrathecal chemotherapy and/or low dose maintenance therapy (for example vinca alkaloids, mercaptopurine, methotrexate, or hydroxyurea). Any low dose chemotherapy as stated above must be discontinued before starting pre-phase chemotherapy and/or dexamethasone.
- Prior/Concomitant Therapy: Immunotherapy (eg, rituximab, alemtuzumab) within 4 weeks before start of protocol specified therapy
- Prior/Concurrent Clinical Study Experience: Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment in another investigational device or drug study(ies). This does not apply to other investigational procedures or participation in observational research studies.
See the full eligibility criteria
Who can join
- Participant’s 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 before any study-specific activities/procedures being initiated.
- Age 28 days to < 12 years at the time of consent
- Lansky Performance Status (LPS) of ≥ 50%
- Prior CD19-directed therapy such as blinatumomab or CD19 chimeric antigen receptor T cells (CAR-T) cells 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 (see CNS exclusion criteria below).
- Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
- For Phase 1b and Phase 2 cohort in participants with R/R B-ALL (Ph2-R): Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic HSCT Refractory disease is defined as the failure to achieve CR. Relapsed disease is defined as isolated hematological relapse or combined hematological and extramedullary (EM) relapse after achieving a CR. Greater than or equal to 5% blasts in the BM is considered as relapse in the BM.
- For Phase 2 cohort in participants with MRD+ B-ALL (Ph2-M): Participants with MRD+ B-ALL must have between ≥ 0.1% and < 5% blasts in the BM. With a peripheral blood count as defined below: ANC (neutrophils) ≥ 500/μL; Platelets ≥ 50,000/μL (transfusion permitted)
- For Phase 2 cohort in participants with MRD+ B-ALL (Ph2-M):Submission of an archival bone marrow specimen from primary diagnosis or relapse for clone-specific calibration of MRD. See section 8.2.9 and the lab manual for minimum sample requirements. For patients in the US and Canada that have a prior Adaptive clonoSEQ result from bone marrow testing that can be made available for use in this study for clone specific calibration, this may be acceptable in lieu of the archival bone marrow specimen with approval by the Medical Monitor. The participant must also provide consent to the use of the prior clonoSEQ result.
What rules you out
- Disease Related: Active ALL in the CNS. If CSF leukemia is present, participants must receive intrathecal therapy and have documented negative CSF prior to enrolling.
- Prior/Concomitant Therapy: 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
- Prior/Concomitant Therapy: Allogeneic HSCT within 12 weeks before the start of blinatumomab
- Prior/Concomitant Therapy: Cancer chemotherapy within 2 weeks before the start of protocol specified therapy, with the exception of intrathecal chemotherapy and/or low dose maintenance therapy (for example vinca alkaloids, mercaptopurine, methotrexate, or hydroxyurea). Any low dose chemotherapy as stated above must be discontinued before starting pre-phase chemotherapy and/or dexamethasone.
- Prior/Concomitant Therapy: Immunotherapy (eg, rituximab, alemtuzumab) within 4 weeks before start of protocol specified therapy
- Prior/Concurrent Clinical Study Experience: Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment in another investigational device or drug study(ies). This does not apply to other investigational procedures or participation in observational research studies.
- Diagnostic Assessments: Abnormal screening laboratory values as defined below: Direct bilirubin > 3.0 mg/dL prior to start of treatment; Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min. per 1.73 m2 per the Revised Schwartz equation for children 2 to < 12 years. For children < 2 years of age, at least 50% of age and gender appropriate normal
- Other Exclusions: Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the Participant, Participant’s legal guardian’s, and investigator’s knowledge. Completion of patient reported outcomes questionnaires is not required and will not be prohibitive to enrollment in case patient has intellectual disability or cognitive impairment or in case instrument is unavailable in subject’s language.
- History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures or completion. Completion of patient reported outcomes questionnaires is not required and will not be prohibitive to enrollment in case patient has intellectual disability or cognitive impairment or in case instrument is unavailable in subject’s language.
- Other Medical Conditions: History of other malignancy within the past 3 years, with the following exception: Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
- Other Medical Conditions: 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 ICANS from prior CAR-T or other T-cell engager therapies.
- Other Medical Conditions: Isolated EMdisease
- Other Medical Conditions: Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
- Other Medical Conditions: Patients with Down Syndrome are not eligible for this study
- Prior/Concomitant Therapy: Known hypersensitivity to blinatumomab or to any component of the product formulation. Sensitivity to any of the products administered during dosing.
- Prior/Concomitant Therapy: Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication.
- Prior/Concomitant Therapy: Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Japan
- China
- Canada
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Japan; China; Canada; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.