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Blinatumomab After Stem Cell Transplant for High-Risk B-ALL

This study is looking at a new way to treat high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL) in children, adolescents, and young adults up to age 25. It combines a special type of stem cell transplant (called alpha/beta T-cell and B-cell depleted HCT) with a drug called blinatumomab. Blinatumomab is an immunotherapy that helps your own immune system fight cancer. The goal is to see if this combination can reduce the chance of the leukemia coming back and improve survival, while also reducing side effects. To join, you must have B-ALL, be in remission, and meet certain risk criteria. The study aims to enroll 25 participants and is currently unclear regarding its recruitment status. The main goal is to see how many patients can successfully receive the blinatumomab infusion after the transplant.

Study design
This is an interventional study with an estimated enrollment of 25 participants. It is a pilot study for children, adolescents, and young adults with B-ALL.
What's involved
You would receive an alpha/beta T-cell and B-cell depleted HCT, followed by a 28-day continuous infusion of blinatumomab around 100 days after the transplant, if there are no significant ongoing side effects.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for feasibility is measured at Day +100 post-HCT, which indicates follow-up at least until this point.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04746209

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Recruiting
PHASE2Up to 25InterventionalTreatment
Medical College of Wisconsin
~25 participants
Updated 2021-09-17 on ClinicalTrials.gov
What's tested:Alpha/Beta T-cell and B-cell depleted HCTBlinatumomab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]
Measured over Day +100 post-HCT

Conditions

B-cell Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
B-Cell ALL, Childhood

Explore related trials

B Acute Lymphoblastic Leukemia

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Rachel Phelan, MD, MPH · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Meredith Beversdorf, RN
[email protected]
414-266-5891
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]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