Clinical trial Recruiting at 1 site Phase 2 Interventional Ages Any age to 25

Blinatumomab treatment after specific stem cell transplant for high-risk leukemia

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

Run by Medical College of Wisconsin · NCT04746209 · Data updated 2026-11-12

This study is testing if a new treatment using blinatumomab after a special type of stem cell transplant can help children and young adults with high-risk leukemia stay in remission and live longer.

Quick facts

PhasePhase 2
Study typeInterventional
AgesAny age to 25 Years
SexAll
Enrollment25 (estimated)
SponsorMedical College of Wisconsin
Academic / other
Drugs / interventionsblinatumomab, CAR T, chemotherapy, Immunotherapy, radiation
Locations1 site (Milwaukee, Wisconsin)
StatusRecruiting
StartedFebruary 1, 2021
Main results expectedFebruary 28, 2024
Study endsDecember 31, 2029
Registry record updatedSeptember 17, 2021
Trial IDNCT04746209 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children, adolescents, and young adults up to 25 years old with high-risk B-ALL who have an available unrelated or haploidentical donor.

Probably not a fit

Patients with low-risk B-ALL or those who do not meet the specific eligibility criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the feasibility of using alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for children and young adults with high-risk B-cell acute lymphoblastic leukemia (ALL). The study aims to reduce relapse rates and improve survival while minimizing treatment-related complications. Patients will be stratified based on their minimal residual disease (MRD) status prior to HCT, with different conditioning regimens applied accordingly. The trial is a multi-institutional pilot study involving up to 25 participants.

Why it matters

Potential benefit: If successful, this approach could significantly reduce relapse rates and improve survival outcomes for high-risk B-ALL patients.

How similar studies have gone: Other studies have shown promising results with similar approaches in treating high-risk leukemia, indicating potential for success in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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:

  1. In remission after first relapse or greater (≥ CR2)
  2. Very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL)
  3. 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
* 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

Exclusion Criteria:

* 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.

Where it's running

  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin, United States
    Recruiting

Study contacts

  • Principal investigator: Rachel Phelan, MD, MPH — Medical College of Wisconsin
  • Study coordinator: Meredith Beversdorf, RN
  • Email: mbeversdorf@chw.org
  • Phone: 414-266-5891

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.