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L'essai clinique NCT04468841 pour Lymphome folliculaire est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Centre de cancérologie Memorial Sloan KetteringMeasuring Cell-Free DNA (cfDNA) Levels in People With Follicular Lymphoma Phase I 100
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04468841 est conçu pour étudier le diagnostic de Lymphome folliculaire. Il s'agit d'une étude interventionnel en Phase I. Son statut actuel est : en recrutement. L'étude a débuté le 8 juillet 2020 et vise à recruter 100 participants. Dirigée par le Centre de cancérologie Memorial Sloan Kettering, l'étude devrait être terminée d'ici le 1 juillet 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 août 2025.
Résumé succinct
The researchers are doing this study to measure and test cell-free DNA (cfDNA) in the blood before, during, and after first-line treatment for follicular lymphoma. They will look at whether cfDNA levels are related to a person's response to the usual first-line treatment for follicular lymphoma. Researchers also want to understand how different genetic changes in follicular lymphoma relate to a person's response to t...Afficher plus
Description détaillée
This is a non-therapeutic protocol aimed to assess the ability of the s cfDNA assay to detect clinical response in FL when compared to conventional approaches for assessing response, such as PET-CT scans.
Study assessments will include: 1) identification of the mutations present in the primary tumor, 2) identification of these mutations in the peripheral blood samples collected before initiation of standard therapy,...
Afficher plusTitre officiel
An Exploratory Study to Correlate the Level of Cell-free DNA With Response to First-line Treatment in Patients With Follicular Lymphoma
Pathologies
Lymphome folliculaireAutres identifiants de l'étude
- 20-199
Numéro NCT
Date de début (réel)
2020-07-08
Dernière mise à jour publiée
2025-08-19
Date de fin (estimée)
2026-07
Inscription (estimée)
100
Type d'étude
Interventionnel
PHASE
Phase I
Statut
En recrutement
Mots clés
Cell-free DNA
20-199
20-199
Objectif principal
Diagnostic
Méthode d'allocation
Non randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalProspective Group Study participants with untreated, newly diagnosed follicular lymphoma will have blood collected for cfDNA testing before, during, and after their first-line treatment or observation period | cfDNA testing peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay. For retrospective patients, blood samples will be collected once. sample of saliva or fingernail clipping collected in clinic one time pre-treatment test specimen From bone marrow, blood, lymph node, or alternate site to identify tumor-specific mutations. For retrospective patients initial tumor tissue (if available). PET/CT, CT, or MRI testing PET/CT scans are required at baseline and at the patient's end-of-treatment visit. The other standard-of-care scan timepoints can be performed using PET/CT, dedicated CT, or MRI per the treating investigator's discretion. |
ExpérimentalRetrospective Group Study participants who have received first-line treatment for follicular lymphoma and are in complete remission will have blood collected for cfDNA testing. In the retrospective cohort, MSKCC patients with CRs lasting ≥10 years after induction therapy will be studied. Initial tumor tissue (if available) will be collected to examine the status of s cfDNA in patients with long-term remissions. Blood samples will be col...Afficher plus | cfDNA testing peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay. For retrospective patients, blood samples will be collected once. sample of saliva or fingernail clipping collected in clinic one time pre-treatment test specimen From bone marrow, blood, lymph node, or alternate site to identify tumor-specific mutations. For retrospective patients initial tumor tissue (if available). PET/CT, CT, or MRI testing PET/CT scans are required at baseline and at the patient's end-of-treatment visit. The other standard-of-care scan timepoints can be performed using PET/CT, dedicated CT, or MRI per the treating investigator's discretion. |
Critère principal d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
whether the assay can correctly identify presence of disease in patients with measurable disease | Response will be evaluated using the updated response criteria entitled, "The Lugano Classification" system. The investigator will use of the 5-point scale for visually assessing response on the pre- and end-of-treatment FDGPET/CT scans. This scale is commonly referred to as the Deauville criteria; it was developed by international experts in the field at the First International Workshop on interim-PET in Lymphoma in Deauville in 2009 and is routinely applied to patients undergoing lymphoma directed therapy. The 5-point scale is described in the table below.
1 No residual uptake 2 Uptake ≤ mediastinum 3 Uptake \> mediastinum but ≤ liver 4 Uptake moderately \> liver 5 Markedly increased uptake at any site or progression | 2 years |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- ≥18 years of age at time of signing informed consent. Consent is permitted from either the participant or from a Legally Authorized Representative (LAR) on their behalf.
- Histology-confirmed follicular lymphoma grade 1-3a, verified by the enrolling institution
- Ability to adhere to the study visit schedule and all the protocol requirements
- Measurable FDG-avid disease
- Not applicable for retrospective patients in CR
- Patients receiving second or greater line of therapy (except in retrospective cohort of long-term survivors of FL \[i.e. \>10 years out from frontline treatment\])
Centre de cancérologie Memorial Sloan Kettering739 essais cliniques actifs à explorerContact central de l'étude
Contact: Paola Ghione, MD, 646-608-4263, [email protected]
Contact: Maria Arcila, MD, 212-639-7879
7 Centres de l'étude dans 1 pays
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Paola Ghione, MD, Contact, 646-608-4263
En recrutement
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, 07748, United States
Paola Ghione, MD, Contact, 646-608-4263
En recrutement
Memorial Sloan Kettering Bergen (All protocol Activities), Montvale, New Jersey, 07645, United States
Paola Ghione, MD, Contact, 646-608-4263
En recrutement
New York
Memorial Sloan Kettering Commack (All Protocol Activities), Commack, New York, 11725, United States
Paola Ghione, MD, Contact, 646-608-4263
En recrutement
Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, 10604, United States
Paola Ghione, MD, Contact, 646-608-4263
En recrutement
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States
Paola Ghione, MD, Contact, 646-608-4263
Maria Arcila, MD, Contact, 212-639-7879
En recrutement
Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, 11553, United States
Paola Ghione, MD, Contact, 646-608-4263
En recrutement