Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07614035

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Identify potential predictors of toxicity to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma

    Time frame: 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

  2. Identify potential predictors of response to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma

    Time frame: 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

  3. Identify and describe potential mechanisms of resistance (ongoing metabolic progression or at the end of BsAbs treatment/metabolic relapse) to BsAbs treatment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice Casadei, MD

CONTACT

[email protected]

+39 051 2143480

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: ASCLEPIO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.