Circulating Tumor DNA Genotyping for Biological Monitoring of Patients Treated in the FIL-Rouge Clinical Trial

NCT05066555 | Completed

• 1 other identifier: FIL-RougeBIO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 13

Brief Summary

Prospective, multicenter, non-interventional, biological study ancillary to FIL-Rouge clinical trial (NCT03159897) enrolling patients affected by Advanced-stage Hodgkin Lymphoma, ABVD-based upfront treatment in 19 centers in Italy part of Fondazione Italiana Linfomi.

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma; ABVD treatment; ancillary; ctDNA; cHL; FIL-Rouge; PFS; Response Rate

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

  Complete Response Rate (CRR) is defined as the proportion of patients achieving a Complete Remission (CR) at the end of treatment;

  The endpoint will be assessed from the beginning of the study up to 76 months

Secondary Outcomes (2)

• Diagnostic accuracy of Circulating tumor DNA (ctDNA) analysis versus interim PET/CT (Positron Emission Tomography/Computed Tomography)

  The endpoint will be assessed from the beginning of the study up to 76 months

• Progression Free Survival (PFS) with at least three years of follow up

  The endpoint will be assessed from the beginning of the study up to 76 months

Study Arms (2)

Advanced-stage Hodgkin Lymphoma patients (1)

All patients will be accrued by investigators from the 19 best recruiting centers in the FIL-Rouge clinical trial. Patients had undergone to ABVD-based upfront treatment in FIL-Rouge trial (Comparator arm).

Advanced-stage Hodgkin Lymphoma patients (2)

All patients will be accrued by investigators from the 19 best recruiting centers in the FIL-Rouge clinical trial. Patients had undergone to ABVD-based upfront treatment in FIL-Rouge trial (Experimental arm).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Eligibility criteria for participation in this study require: * Enrollment in the FIL-Rouge clinical trial; * Evidence of signed informed consent for the biological FIL-RougeBIO study.

You may qualify if:

• Histologically confirmed classical HL
• Previously untreated disease
• Age 18-60 years
• Ann Arbor stage IIB with extranodal involvement and/or bulk, III and IV
• At least one target PET-avid bidimensionally assessable lesion
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2
• Adequate organ and marrow function as defined below:
• Absolute neutrophil count \>1,0 x109/L, platelets \>75 x109/L
• Total bilirubin \<2 mg/dl without a pattern consistent with Gilbert's syndrome
• Aspartate Transaminase and Alanine Transaminase (AST/ALT) \<3 X institutional Upper Limits of Normality (ULN)
• Creatinine within normal institutional limits or creatinine clearance \>50 mL/min/1.73 m2
• Females of childbearing must have a negative pregnancy test under medical supervision even if patients had been using effective contraception
• Life expectancy \> 6 months
• Able to adhere to the study visit schedule and other protocol requirements
• Signed (or legally acceptable representatives must sign) informed consent indicating that patients understand the purpose of and procedures required for the study and are willing to participate in the study.

You may not qualify if:

• Nodular Lymphocyte Predominant HL
• Ann Arbor stage IIB without extranodal involvement and/or mediastinal bulky
• Prior chemotherapy or radiation therapy
• Pregnant or lactating females
• Known hypertension, cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.
• Abnormal QTc interval prolonged (\>450 msec in males; \>470 msec in women)
• Diffusion lung capacity for CO (DLCO)and/or Forced expiratory volume in the 1st second (FEV1) tests \<50% of predicted not due to mediastinal compression or parenchymal lymphoma
• Known cerebral or meningeal disease (HL or any other etiology)
• Prior history of malignancies unless the patient has been free of the disease for five years. Exceptions include the following: basal cells carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast and prostate cancer with the TNM stage of T1a or T1b
• Uncontrolled infectious disease
• Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (Hepatitis B core) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided (Lamivudine)
• Uncompensated diabetes
• Refusal of adequate contraception
• Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (13)

Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

Avellino, Italy

Location

IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia

Bari, Italy

Location

ASST Spedali Civili di Brescia - Ematologia

Brescia, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Milan, Italy

Location

Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica

Napoli, Italy

Location

Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

Pagani, Italy

Location

A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

Palermo, Italy

Location

IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

Pavia, Italy

Location

Ospedale S. Maria della Misericordia - Ematologia

Perugia, Italy

Location

P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

Pescara, Italy

Location

Ospedale degli Infermi di Rimini - U.O. di Ematologia

Rimini, Italy

Location

Istituto Clinico Humanitas - U.O. Ematologia

Rozzano, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia

Torino, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected in Cell-Free DNA BCT tubes before treatment start, at the interim PET/CT (Positron Emission Tomography/Computed Tomography), at the end of treatment assessment, and at the time of disease progression/relapse and will be analyzed for ctDNA (Circulating tumor DNA) and gDNA (genomic DNA) genotyping and for cytokines and chemokines levels.

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Antonio Pinto, MD

  Dipartimento di Ematologia, Istituto Nazionale Tumori, Fondazione Pascale, IRCCS, Napoli, Italy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 4, 2021
• Study Start: April 8, 2020
• Primary Completion: November 2, 2021
• Study Completion: November 3, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

IT (13)