Non-Hodgkin Lymphoma
Conditions
Keywords
Non-Hodgkin Lymphoma, bispecific antibodies
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify potential predictors of toxicity to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma | 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 |
| Identify potential predictors of response to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma | 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 |
| Identify and describe potential mechanisms of resistance (ongoing metabolic progression or at the end of BsAbs treatment/metabolic relapse) to BsAbs treatment | 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 |
Countries
Italy
Contacts
CONTACTBeatrice Casadei, MD
Outcome results
None listed