B-cell Acute Lymphoblastic LeukemiaPhase 2NCT04746209
Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT
A Phase 2 study testing Alpha/Beta T-cell and B-cell depleted HCT and Blinatumomab in people with B-cell Acute Lymphoblastic Leukemia and B-cell Childhood Acute Lymphoblastic Leukemia, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing… Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, B-Cell ALL, Childhood
- What is being tested?
- Alpha/Beta T-cell and B-cell depleted HCT and Blinatumomab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 with no evidence of minimal residual disease in the bone marrow by multi-parameter flow cytometry (FC-MRD negative, <0.01%) and meet at least one of the following:
- In remission after first relapse or greater (≥ CR2)
- Very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL)
- First remission with persistent disease identified as end of consolidation (EOC) MRD > 0.01%.
- Patients must have an available unrelated or haploidentical donor
- Age ≤ 25 years at time of study enrollment
Show all 14Show fewer
- Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age
- Have acceptable organ function as defined within 14 days of study registration: Renal: creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73m2 Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 3 mg/dL Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA Pulmonary: No evidence of dyspnea at rest. No supplemental oxygen requirement. If measured, carbon monoxide diffusion capacity (DLCO) > 50%. Central Nervous System: Based on clinical exam, no concern for/evidence of active CNS infection. Patients with fully treated prior CNS infections are eligible. Patients with seizure disorders may be enrolled if seizures are well-controlled on anticonvulsant therapy.
- 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.
- Immunotherapy: At least 42 days after the completion of any type of immunotherapy aside from blinatumomab (e.g. tumor vaccines or CAR T-cell therapy).
- XRT: Cranial or craniospinal XRT is prohibited during protocol therapy. ≥ 90 days must have elapsed if prior TBI, cranial 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 completion of blinatumomab therapy. Sexually active men must agree to use barrier contraceptive for the duration of treatment and for 2 months after the completion of blinatumomab therapy.
- 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.
- All patients enrolled in this study must have been enrolled in the Blinatumomab Bridging Therapy (BBT) Trial
Who cannot join
- Active extramedullary disease or presence of chloromatous disease.
- Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease 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). Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
- 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 registration to rule out pregnancy.
- Known allergy to any chemotherapies or targeted agents included in this protocol.
- Participating in a concomitant Phase 1 or 2 study involving treatment of disease.
- Active malignancy other than B-ALL.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Meredith Beversdorf, RN, 414-266-5891, mbeversdorf@chw.org
Emily Ruszkiewicz, BS, 414-266-4092, eruszkiewicz@mcw.edu
About this study
Official title: Alpha/Beta T-cell and B-cell Depleted Allogeneic Transplantation (IDE 13641) Followed by Blinatumomab Therapy for High-Risk B-Acute Lymphoblastic Leukemia: A Pilot Study
This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.
Read the detailed description
This trial evaluates the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce the risk of leukemia relapse following HCT to improve post-HCT outcomes. The investigators will also utilize an alpha-beta T-cell and B-cell depleted graft to reduce the risk of GVHD along with a reduced intensity conditioning regimen without the use of TBI in patients who are minimal residual disease (MRD) negative using high throughput sequencing (HTS) prior to HCT. For those patients who remain HTS-MRD positive, a myeloablative conditioning regimen will be utilized, also followed by blinatumomab. This multi-institutional pilot study will be limited to 25 (estimated 10-15 per stratum) evaluable children, adolescents and young adults with B-ALL, that have experienced a relapse or have high-risk disease.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, B-Cell ALL, Childhood
- Being tested
- Alpha/Beta T-cell and B-cell depleted HCT, 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.
Alpha/Beta T-cell and B-cell depleted HCTDevice
Device: Alpha/Beta T-cell and B-cell depletion
BlinatumomabDrug
Also called Blincyto
28 day continuous infusion given on Day 100 post-HCT if no significant ongoing GVHD
| Study group | Role | What they receive |
|---|---|---|
| Alpha/beta T-cell and B-cell Depleted, Myeloablative HCT | Experimental | Patients who are MRD Negative by Flow cytometry but are MRD Positive by High Throughput Sequencing, will receive a myeloablative conditioning regimen which includes total body irradiation (TBI) followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD. Receives: Device: Alpha/Beta T-cell and B-cell depleted HCT; Drug: Blinatumomab |
| Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCT | Experimental | Patients who are MRD Negative by Flow cytometry and are MRD Negative by High Throughput Sequencing, will receive a reduced intensity conditioning regimen followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD. Receives: Device: Alpha/Beta T-cell and B-cell depleted HCT; Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]
Percentage of patients who are able to receive the blinatumomab infusion at day +100 post-HCT and complete a minimum of 14/28 planned days
Measured: Day +100 post-HCT
Secondary outcomes (12)
Cumulative incidence of treatment-related adverse events [Tolerability]
As defined by cumulative incidence of treatment-related adverse events of blinatumomab post-HCT
Measured: Day of HCT to Day +180 post-HCT
Overall Survival
Defined as the time interval from the date of transplant to death or last follow up
Measured: Day of HCT to 1 year post-HCT
Disease Free Survival
Defined as the time interval from the date of transplant to death or last follow up or disease relapse
Measured: Day of HCT to 1 year post-HCT
Engraftment
Defined as the number of patients who achieve ANC > 500/uL for 3 consecutive days
Measured: Day +100 and +1 year post-HCT
Primary Graft Failure
is defined as failure to achieve ANC > 500/uL by Day +28
Measured: Day +28 and + 1 year post-HCT
Secondary Graft Failure
Patients who initially achieve neutrophil engraftment followed by a decline in ANC < 500/uL that is unresponsive to growth factor therapy
Measured: Day +28 and +1 year post-HCT
Treatment Related Mortality
Defined as death occurring in a patient from causes other than disease relapse or progression
Measured: Day of HCT to Day +100 and 1 year post-HCT
Acute & Chronic GVHD
Incidences of Grades 2-4 and Grades 3-4 acute GVHD
Measured: Day +100, +180 and 1 year post-HCT
Patient Reported Outcomes
PROMIS Pediatric/Parent Proxy Profile 25 (either pediatric self-report if age 8-17 or parent proxy if age 5-8, or both if feasible) or PROMIS-29 Profile if age 18 or older
Measured: Baseline, Day +100, +180, +1 year post-HCT
Length of Stay
Define by the total number of days a patient spends in the hospital
Measured: Number of days between the day of transplantation, Day 0, and Day +180 post-HCT
Persistence of Minimal Residual Disease (MRD) Negativity
Number of patients remaining MRD negative by flow cytometry and/or high throughput sequencing
Measured: Days +28, +100, +180 and +1 year post-HCT
Relapse
Cumulative incidence of relapse in all patients
Measured: Day of HCT to day +180 and 1 year post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Feb 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, University of Wisconsin, Madison
- Responsible party
- Principal investigator, Rachel Phelan, Medical College of Wisconsin
- Investigators
- Rachel Phelan, MD, MPH, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746209
- Sponsor's protocol ID
- Blina Part 2
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha/Beta T-cell and B-cell Depleted Allogeneic Transplantation (IDE 13641) Followed by Blinatumomab Therapy for High-Risk B-Acute Lymphoblastic Leukemia: A Pilot Study
- ClinicalTrials.gov ID
- NCT04746209
- Acronym / sponsor ID
- Blina Part 2
- Conditions
- B-cell Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, B-Cell ALL, Childhood
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Amgen, University of Wisconsin, Madison
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.
Detailed description
This trial evaluates the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce the risk of leukemia relapse following HCT to improve post-HCT outcomes. The investigators will also utilize an alpha-beta T-cell and B-cell depleted graft to reduce the risk of GVHD along with a reduced intensity conditioning regimen without the use of TBI in patients who are minimal residual disease (MRD) negative using high throughput sequencing (HTS) prior to HCT. For those patients who remain HTS-MRD positive, a myeloablative conditioning regimen will be utilized, also followed by blinatumomab. This multi-institutional pilot study will be limited to 25 (estimated 10-15 per stratum) evaluable children, adolescents and young adults with B-ALL, that have experienced a relapse or have high-risk disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha/beta T-cell and B-cell Depleted, Myeloablative HCT | Experimental | Device: Alpha/Beta T-cell and B-cell depleted HCT, Drug: BlinatumomabPatients who are MRD Negative by Flow cytometry but are MRD Positive by High Throughput Sequencing, will receive a myeloablative conditioning regimen which includes total body irradiation (TBI) followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD. |
| Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCT | Experimental | Device: Alpha/Beta T-cell and B-cell depleted HCT, Drug: BlinatumomabPatients who are MRD Negative by Flow cytometry and are MRD Negative by High Throughput Sequencing, will receive a reduced intensity conditioning regimen followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Diagnosis of B-ALL with no evidence of minimal residual disease in the bone marrow by multi-parameter flow cytometry (FC-MRD negative, <0.01%) and meet at least one of the following:
- Patients must have an available unrelated or haploidentical donor
- Age ≤ 25 years at time of study enrollment
- Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age
- Have acceptable organ function as defined within 14 days of study registration: Renal: creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73m2 Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 3 mg/dL Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA Pulmonary: No evidence of dyspnea at rest. No supplemental oxygen requirement. If measured, carbon monoxide diffusion capacity (DLCO) > 50%. Central Nervous System: Based on clinical exam, no concern for/evidence of active CNS infection. Patients with fully treated prior CNS infections are eligible. Patients with seizure disorders may be enrolled if seizures are well-controlled on anticonvulsant therapy.
Key exclusion criteria (7 listed)
- Active extramedullary disease or presence of chloromatous disease.
- Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease 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). Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
- 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 registration to rule out pregnancy.
- Known allergy to any chemotherapies or targeted agents included in this protocol.
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 |
|---|---|---|
| Alpha/Beta T-cell and B-cell depleted HCTDevice: Alpha/Beta T-cell and B-cell depletion | Device | Alpha/beta T-cell and B-cell Depleted, Myeloablative HCT, Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCT |
| BlinatumomabAlso: Blincyto28 day continuous infusion given on Day 100 post-HCT if no significant ongoing GVHD | Drug | Alpha/beta T-cell and B-cell Depleted, Myeloablative HCT, Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCT |
Primary outcome
Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]
Time frame: Day +100 post-HCT
Percentage of patients who are able to receive the blinatumomab infusion at day +100 post-HCT and complete a minimum of 14/28 planned days
12 secondary outcomes
Cumulative incidence of treatment-related adverse events [Tolerability]
Time frame: Day of HCT to Day +180 post-HCT
Overall Survival
Time frame: Day of HCT to 1 year post-HCT
Disease Free Survival
Time frame: Day of HCT to 1 year post-HCT
Engraftment
Time frame: Day +100 and +1 year post-HCT
Primary Graft Failure
Time frame: Day +28 and + 1 year post-HCT
Secondary Graft Failure
Time frame: Day +28 and +1 year post-HCT
Treatment Related Mortality
Time frame: Day of HCT to Day +100 and 1 year post-HCT
Acute & Chronic GVHD
Time frame: Day +100, +180 and 1 year post-HCT
Patient Reported Outcomes
Time frame: Baseline, Day +100, +180, +1 year post-HCT
Length of Stay
Time frame: Number of days between the day of transplantation, Day 0, and Day +180 post-HCT
Persistence of Minimal Residual Disease (MRD) Negativity
Time frame: Days +28, +100, +180 and +1 year post-HCT
Relapse
Time frame: Day of HCT to day +180 and 1 year post-HCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- 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.
Rachel Phelan, MD, MPH principal investigator
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 Alpha/Beta T-cell and B-cell depleted HCT and Blinatumomab in people with B-cell Acute Lymphoblastic Leukemia and B-cell Childhood Acute Lymphoblastic Leukemia, run by Medical College of Wisconsin 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 14 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meredith Beversdorf, RN (414-266-5891, mbeversdorf@chw.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who are able to receive the blinatumomab infusion [Feasibility] (time frame: Day +100 post-HCT). 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 NCT04746209, 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 17 Sep 2021.