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Identification of the Best Treatment Pathway for Patients With Relapsed/Refractory Lymphocytic B-derived Non-Hodgkin Lymphoma (ASCLEPIO)

22. maj 2026 opdateret af: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Identification of the Best Treatment Pathway for Patients With Relapsed/Refractory Lymphocytic B-derived Non-Hodgkin Lymphoma, Through the Identification of Prognostic Factors and Mechanisms of Resistance to Bispecific Antibody Therapy

Bispecific antibodies have demonstrated high efficacy in the treatment of Refractory/relapsed b-cell non-Hodgkin lymphomas. However, a non-negligible percentage of patients do not respond to therapy and/or develop significant treatment toxicity.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

This exploratory study aims to obtain a first identification of clinical and biological characteristics related to response and toxicity to bispecific antibodies.

Having this information, currently not available in the scientific literature and to be validated in further studies, therapies with BsAbs can be addressed only to patients for whom they have proven useful, improving the results of the therapy pharmacological (more responses and less toxicity) and consequently the sustainability and efficiency of the healthcare system.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

70

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This is a single-center, observational pharmacological, non-profit study with a tissue component and collection of biological samples, which involves a prospective enrollment of patients treated with BsAbs who will be followed for a period of at least 18 months. All patients will be treated according to clinical practice and will follow the clinical care pathway required by the standard operating procedures of the IRCCS AOUBO Hospital Authority.

The search for biomarkers predictive of response and toxicity, as well as the description of potential resistance mechanisms to BsAbs treatment, will be conducted by a multidisciplinary team involving several Operational Units (UOs) of the IRCCS AOUBO.

In particular, the units involved in the specific study analyses will be the Nuclear Medicine Operational Unit, Hemolymphopathology, Gastroenterology and Digestive Endoscopy, Internal Medicine and Digestive Pathophysiology and the Biology and Molecular Medicine Platform, Intestinal Microbiomics.

Beskrivelse

Inclusion Criteria:

  • Age≥18 years
  • Patients with histologically documented non-Hodgkin B lymphoma, with relapsed/refractory disease and candidates for BsAbs therapy (glofitamab, epcoritamab, mosunetuzumab) according to clinical indication and AIFA reimbursement criteria
  • obtaining signed and dated informed consent before the start of any screening or study-specific procedure

Exclusion Criteria:

  • Evidence of concomitant and uncontrolled diseases that could affect protocol compliance or interpretation of results.
  • Concomitant secondary neoplasm.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identify potential predictors of toxicity to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma
Tidsramme: During the entire duration of treatment and up to 12 months after the last administration

Therapy toxicity defined as the occurrence of at least one of the following conditions:

  • hematological toxicity of degree > 3
  • extra-hematological toxicity of degree > 2
  • CRS and ICANS of any degree
During the entire duration of treatment and up to 12 months after the last administration
Identify potential predictors of response to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma
Tidsramme: At the end of treatment, approximately 1 month after last cycle treatment (up to 12 months from baseline). Indiviadual cycle lengths range from 21 to 28 days depending on the specific drug regimen, with a maximum treatment duration of 12 months.

Response to therapy defined as the occurrence of any of the following conditions:

  • CR
  • PR
  • stable response (SD, stable disease)
  • disease progression (PD, progression disease) assessed by performing PET/CT radiological examination and measured by the Deauville score
At the end of treatment, approximately 1 month after last cycle treatment (up to 12 months from baseline). Indiviadual cycle lengths range from 21 to 28 days depending on the specific drug regimen, with a maximum treatment duration of 12 months.
Identify and describe potential mechanisms of resistance (ongoing metabolic progression or at the end of BsAbs treatment/metabolic relapse) to BsAbs treatment
Tidsramme: Through study completion, up to 12 months

Presence (yes/no) of resistance to the treatment, identified by PET (Deauville Score) in patients undergoing at least 1 course of treatment, in case of SD >3, through:

  • Histological examination and characterization in IHC of lymphomatous cells and their TME pre therapy and at relapse/progression
  • Characterization longitudinal of the GM and the intestinal permeability and of their changes in the time
  • Parameter analysis semi-quantitative in PET
Through study completion, up to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juni 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ASCLEPIO
  • RC-2025-2794601 (Andet bevillings-/finansieringsnummer: Ministry of health)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Non-Hodgkin lymfom

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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