Trial Radar IA | ||
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Lo studio clinico NCT07478848 per Large B Cell Lymphoma, Linfoma non Hodgkin (LNH), Linfoma diffuso a grandi cellule B (DLBCL), Linfoma diffuso a grandi cellule B refrattario, Diffuse Large B Cell Lymphoma Relapsed è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Centro oncologico AbramsonRadiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas Fase I 14 Terapia cellulare
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07478848 è uno studio interventistico di Fase I volto a esaminare il trattamento per Large B Cell Lymphoma, Linfoma non Hodgkin (LNH), Linfoma diffuso a grandi cellule B (DLBCL), Linfoma diffuso a grandi cellule B refrattario, Diffuse Large B Cell Lymphoma Relapsed, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 7 aprile 2026, con l'obiettivo di raggiungere 14 partecipanti. Sotto la guida di il Centro oncologico Abramson, dovrebbe concludersi entro il 1 gennaio 2029. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 18 marzo 2026.
Sommario breve
This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas
Titolo ufficiale
A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy
Patologie
Large B Cell LymphomaLinfoma non Hodgkin (LNH)Linfoma diffuso a grandi cellule B (DLBCL)Linfoma diffuso a grandi cellule B refrattarioDiffuse Large B Cell Lymphoma RelapsedAltri ID dello studio
- UPCC 69425
- 858761 (Altro identificativo) (University of Pennsylvania Institutional Review Board)
Numero NCT
Data di inizio (effettiva)
2026-04-07
Ultimo aggiornamento pubblicato
2026-03-18
Data di completamento (stimata)
2029-01-01
Arruolamento (previsto)
14
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Parole chiave
non-hodgkin lymphoma
NHL
large B cell lymphoma
DLBCL
diffuse large B cell lymphoma
NHL
large B cell lymphoma
DLBCL
diffuse large B cell lymphoma
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Sperimentalevancomycin with radiation therapy vancomycin 125 mg orally four times per day, followed by standard of care radiation, standard of care CD19 CAR T-cells | Vancomycin 125mg oral |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Cytokine release syndrome | rate of CART-related cytokine release syndrome | date of CAR-T infusion to 28 days after infusion |
Severe adverse events | rate of grade ≥ 3 adverse events attributed to vancomycin or radiation | CAR-T infusion to 28 days after infusion |
VRE | rate of vancomycin-related enterococcus | start of vancomycin to day 28 after CAR-T infusion |
Adverse Events | rate of adverse events (AEs) and serious adverse events (SAEs) | start of vancomycin until day 28 after CAR-T infusion |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Best overall response rate | percentage of all patients who receive CAR-T and have complete response and partial response after CAR-T | CAR-T infusion to 12 months after CAR-T infusion |
Complete response rate | percentage of patients treated with CAR-T who have a complete response | CAR-T infusion to 12 months after CAR-T infusion |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Male or female subject aged ≥ 18 years.
- Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T
- ECOG Performance Status ≤ 2.
- Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T
- Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites
- Subjects must have at least one site of measurable disease based on CT or FDG PET
- Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma
- For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.
The following age-specific requirements apply:
Women < 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses >1 year ago; or had chemotherapy-induced menopause with last menses >1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug
- Known history of vancomycin resistant enterococcus (VRE)
- Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis
- History of radiation pneumonitis or other grade 4 radiation-related adverse event
- Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.
- Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.
- Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.
- Active infection that required the use of antibiotics within 4 weeks prior to registration
- Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures
Centro oncologico Abramson130 studi clinici attivi da esplorareIstituto nazionale dei tumori, Estados UnidosContatti principali dello studio
Contatto: Rachel Lundberg, PA-C, 215-615-5858, [email protected]
Contatto: Brittany Koch, [email protected]
1 Centri dello studio in 1 paesi
Pennsylvania
Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Brittany Koch, Contatto, 215-615-5858, [email protected]