Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT
Eligible age
Up to 25 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this 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.
Sponsor: Medical College of Wisconsin
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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 recruiting
Milwaukee
Source: ClinicalTrials.gov · NCT04746209 · last updated 2021-09-17