NCT05746858

Brief Summary

The goal of this study is to identify biomarkers that will predict outcome to standard and targeted therapies in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The specific aims of the present project are:

  1. 1.To explore associations between expression of target antigens on surface of neoplastic cells of DLBCL patients and response to target therapies
  2. 2.To identify specific miRNA signatures as predictors of response to upfront and salvage immune-chemotherapies in DLBCL patients.
  3. 3.To refine the diagnosis and molecular profiling of DLBCL, and to provide biological information of prognostic relevance in the setting of innovative treatments of patients with DLBCL.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Apr 2023Mar 2027

First Submitted

Initial submission to the registry

February 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 17, 2023

Last Update Submit

February 17, 2023

Conditions

Diffuse Large B Cell LymphomaRelapsed Non-Hodgkin Lymphoma

Keywords

miRNAflow cytometrynext generation sequencing

Outcome Measures

Primary Outcomes (1)

  • Complete remission

    Complete remission rates according to miRNA signatures, expression of target antigens, mutational status

    2 years

Interventions

no intervention (observational study)OTHER

No intervention (observational study)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

a) newly diagnosed DLBCL patients treated with: i) standard R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) and DA-EPOCH -R regimens; ii) frontline Pola-R-CHP (Polatuzumab vendotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone) as approved by the European Medicine Agency-CHMP (24.03.2022); b) RR-DLBCL patients receiving salvage treatments including: a) R-Pola-Benda (Rituximab, Polatuzumab vendotin, Bendamustine); b) Lenalidomide-Tafasitamab; c) Anti-CD19 CAR-T cells; d) bispecific antibodies (e.g. Glofitamab).

You may qualify if:

  • Diagnosis of DLBCL and RR-DLBCL;
  • Age\>18 years;
  • Eligibility for first-line and/or salvage chemo-immunotherapies as above specified;
  • Measurable and/or evaluable disease (at least one bi-dimensionally measurable lesion on imaging scan defined as \>1.5 cm in its longest dimension);
  • No concomitant active cancers or others life-threatening conditions that can compromise chemotherapy treatment;
  • Available FFPE and fresh tumor tissue (excisional biopsy, Tru-cut microhistology);
  • Informed consent to treatment and use of biologic materials for studies related to the present proposal.

You may not qualify if:

  • Diagnosis of follicular lymphoma grade 3b, lymphoblastic lymphoma, Burkitt lymphoma or primary mediastinal lymphoma;
  • Age ≤ 18 years;
  • Ineligible for first-line and/or salvage chemo-immunotherapies;
  • No measurable and/or evaluable disease;
  • Patients with concomitant active solid tumors or others clinical conditions that can compromise chemotherapy treatment or negatively influence the prognosis;
  • Known history of HIV seropositive status. HIV testing will be performed at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Istituto Nazionale Tumori Fondazione "G. Pascale" IRCCS

Napoli, Italy

Location

Fonadazione Policlinico Universitario A. Gemelli

Roma, Italy

Location

Istituti Fisioterapici Ospitalieri -Istituto Regina Elena

Roma, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Tissue samples in FFPE and fresh tissue samples * Plasma/serum samples

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Non-Hodgkin

Interventions

Observation

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Stefan Hohaus, MD

    Fondazione Policlinico Universitario A. Gemelli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Hohaus, MD

CONTACT

06-30154180stefan.hohaus@unicatt.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

April 1, 2023

Primary Completion

March 31, 2025

Study Completion (Estimated)

March 31, 2027

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

IT(3)