B-cell Acute Lymphoblastic LeukemiaPhase 2NCT04556084
Blinatumomab Bridging Therapy for BALL
A Phase 2 study testing Blinatumomab in people with B-cell Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, run by Michael Burke at 1 site in United States.
Trial summary
The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of B-ALL in hematologic complete remission (defined as an M1 marrow, < 5% blasts) with MRD in the bone marrow (≥ 0.01%) by multi-parameter flow cytometry and that meets one of the following:
- Patients in first relapse or greater;
- OR
- Patients with very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL);
- OR
- Patients who have persistent MRD after Consolidation therapy (End of Consolidation (EOC) MRD positive ≥ 0.01%);
Show all 22Show fewer
- AND with the intent of going on to an allogeneic hematopoietic cell transplantation (HCT) independent of this study
- Patients must have an available donor and have intention of proceeding directly to HCT after completion of 1 to 2 cycles of Bridging therapy with blinatumomab.
- Age ≤ 25 years at time of study enrollment
- Karnofsky Performance Status ≥ 50% for patients 16 years and older and Lansky Play Score ≥ 50 for patients under 16 years of age (see Appendix 1)
- Have acceptable organ function as defined within 7 days of study registration:
- Renal: creatinine clearance ≥ 60 mL/min/1.73m2 or serum creatinine based on age/gender
- Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
- Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA
- At least 7 days must have elapsed from prior chemotherapy.
- Patients who have experienced their relapse after HCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD) and are off all transplant immune suppression therapy for at least 7-days (e.g. steroids, cyclosporine, tacrolimus). Steroid therapy for non-GVHD and/or non-leukemia therapy is acceptable.
- Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
- Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after the last dose of monoclonal antibody (i.e. Inotuzumab = 12 days).
- Immunotherapy: At least 42 days after the completion of any type of immunotherapy (e.g. tumor vaccines or CAR T-cell therapy).
- XRT: Cranio or craniospinal XRT is prohibited during protocol therapy. ≥ 90 days must have elapsed if prior TBI, cranio or craniospinal XRT
- Sexually active females of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment and for 2 months after the last dose of chemotherapy. Sexually active men must agree to use barrier contraceptive for the duration of treatment and for 2 months after the last dose of chemotherapy.
- Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- History of CNS3 disease and/or active central nervous system (CNS) disease (≥ CNS2)
- Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy other than is specified in the protocol.
- Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Pregnant or lactating. The agents used in this study are known to be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 7-days prior to the start of blinatumomab to rule out pregnancy.
- Known allergy to blinatumomab
- Participating in a concomitant Phase 1 or 2 study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Blinatumomab Bridging Therapy in High-Risk B-Acute Lymphoblastic Leukemia: A Phase 2 Study
The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes.
Read the detailed description
The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes. This Phase 2 study will determine the effectiveness of delivering 1 to 2 cycles of blinatumomab (Days 1-28) as bridging therapy in children, adolescent and young adults with relapse or persistent MRD B-ALL. Eligible subjects will receive 1 or 2, 28-day cycles of blinatumomab prior to proceeding to HCT. Centralized MRD assessment will be performed after completion of the 28-days of blinatumomab using both flow cytometry (University of Washington, Brent Wood, MD) and High-Throughput Deep Sequencing (HTS) MRD technologies (Adaptive Technologies, Seattle, WA). Subjects who achieve flow cytometry negative MRD (<0.01%) after a single cycle of blinatumomab can proceed directly to HCT whereas subjects who remain MRD positive by flow cytometry may receive a 2nd cycle of blinatumomab. Subjects who remain MRD positive by flow cytometry after a 2nd cycle of blinatumomab will come off study.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia
- Being tested
- Blinatumomab
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called Blincyto
Blinatumomab will be given as a 28-day continuous infusion with 14-days in between Cycle 1 and Cycle 2 as per the package insert and FDA approved labeling.
Patient weight greater than or equal to 45kg will receive 28 mcg/day
Patient weight less than 45kg will receive 15 mcg/m2/day
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab | Experimental | Up to 2 cycles of continuous infusion blinatumomab will be given based on the end of Cycle 1 disease response. Cycle 2 of blinatumomab can be given to subjects who have achieved remission (< 5% marrow blasts) after Cycle 1 but have persistent disease identified by multi-parameter flow cytometry (minimal residual disease (MRD) positive ≥ 0.01%) after Cycle 1. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects in Complete Remission (CR)
The primary efficacy variable is the percent of subjects that remain in Complete Remission (CR) after completion of 1 or 2 cycles of blinatumomab. Complete remission was defined as <5% blasts in the bone marrow. Complete remission was further defined as minimal residual disease (MRD) positive (>/= to 0.01%) or MRD negative (<0.01%) as measured by flow cytometry of the bone marrow.
Measured: 1 or 2 Months depending on the number of cycles of blinatumomab
Percentage of Subjects Flow Cytometry (FC) -Minimal Residual Disease (MRD) Negative Defined as <0.01% Leukemia
The primary efficacy variable is the percent of subjects that become Flow Cytometry-MRD negative (FC-MRD negative) < 0.01% after completion of 1 or 2 cycles of blinatumomab.
Measured: 1 to 2 Months depending on the number of cycles of blinatumomab
Secondary outcomes (1)
Percentage of Subjects That Are High-Throughput Deep Sequencing (HTS)-Minimal Residual Disease (MRD) Negative Defined as Undetectable
The percent of subjects that achieve MRD negative by molecular High-Throughput Deep Sequencing (HTS-MRD negative) (MRD undetectable) after completion of Blinatumomab bridging therapy, which may consist of 1 to 2 cycles of Blinatumomab.
Measured: After completion of Blinatumomab bridging therapy (1 participant's course consisted of 1 cycle, the other participant's course consisted of 2 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jan 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Burke
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Michael Burke, Medical College of Wisconsin
- Investigators
- Michael Burke, MD, Study chair, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556084
- Sponsor's protocol ID
- Blina Part 1
- Status last verified
- Apr 2025
- First submitted
- 9 Sep 2020
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinatumomab Bridging Therapy in High-Risk B-Acute Lymphoblastic Leukemia: A Phase 2 Study
- ClinicalTrials.gov ID
- NCT04556084
- Acronym / sponsor ID
- Blina Part 1
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Michael BurkeUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes.
Detailed description
The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes. This Phase 2 study will determine the effectiveness of delivering 1 to 2 cycles of blinatumomab (Days 1-28) as bridging therapy in children, adolescent and young adults with relapse or persistent MRD B-ALL. Eligible subjects will receive 1 or 2, 28-day cycles of blinatumomab prior to proceeding to HCT. Centralized MRD assessment will be performed after completion of the 28-days of blinatumomab using both flow cytometry (University of Washington, Brent Wood, MD) and High-Throughput Deep Sequencing (HTS) MRD technologies (Adaptive Technologies, Seattle, WA). Subjects who achieve flow cytometry negative MRD (<0.01%) after a single cycle of blinatumomab can proceed directly to HCT whereas subjects who remain MRD positive by flow cytometry may receive a 2nd cycle of blinatumomab. Subjects who remain MRD positive by flow cytometry after a 2nd cycle of blinatumomab will come off study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab | Experimental | Drug: BlinatumomabUp to 2 cycles of continuous infusion blinatumomab will be given based on the end of Cycle 1 disease response. Cycle 2 of blinatumomab can be given to subjects who have achieved remission (< 5% marrow blasts) after Cycle 1 but have persistent disease identified by multi-parameter flow cytometry (minimal residual disease (MRD) positive ≥ 0.01%) after Cycle 1. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- Diagnosis of B-ALL in hematologic complete remission (defined as an M1 marrow, < 5% blasts) with MRD in the bone marrow (≥ 0.01%) by multi-parameter flow cytometry and that meets one of the following:
- OR
- Patients with very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL);
- OR
- Patients who have persistent MRD after Consolidation therapy (End of Consolidation (EOC) MRD positive ≥ 0.01%);
Key exclusion criteria (6 listed)
- History of CNS3 disease and/or active central nervous system (CNS) disease (≥ CNS2)
- Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy other than is specified in the protocol.
- Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Pregnant or lactating. The agents used in this study are known to be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 7-days prior to the start of blinatumomab to rule out pregnancy.
- Known allergy to blinatumomab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabAlso: BlincytoBlinatumomab will be given as a 28-day continuous infusion with 14-days in between Cycle 1 and Cycle 2 as per the package insert and FDA approved labeling. Patient weight greater than or equal to 45kg will receive 28 mcg/day Patient weight less than 45kg will receive 15 mcg/m2/day | Drug | Blinatumomab |
Primary outcome
Percentage of Subjects in Complete Remission (CR)
Time frame: 1 or 2 Months depending on the number of cycles of blinatumomab
The primary efficacy variable is the percent of subjects that remain in Complete Remission (CR) after completion of 1 or 2 cycles of blinatumomab. Complete remission was defined as <5% blasts in the bone marrow. Complete remission was further defined as minimal residual disease (MRD) positive (>/= to 0.01%) or MRD negative (<0.01%) as measured by flow cytometry of the bone marrow.
Percentage of Subjects Flow Cytometry (FC) -Minimal Residual Disease (MRD) Negative Defined as <0.01% Leukemia
Time frame: 1 to 2 Months depending on the number of cycles of blinatumomab
The primary efficacy variable is the percent of subjects that become Flow Cytometry-MRD negative (FC-MRD negative) < 0.01% after completion of 1 or 2 cycles of blinatumomab.
1 secondary outcome
Percentage of Subjects That Are High-Throughput Deep Sequencing (HTS)-Minimal Residual Disease (MRD) Negative Defined as Undetectable
Time frame: After completion of Blinatumomab bridging therapy (1 participant's course consisted of 1 cycle, the other participant's course consisted of 2 cycles)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Burke, MD study chair
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blinatumomab in people with B-cell Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, run by Michael Burke at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects in Complete Remission (CR) (time frame: 1 or 2 Months depending on the number of cycles of blinatumomab). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.