- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05238064
Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL
PI3Kδ Inhibitor Parsaclisib in Combination With Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in Participants With Previously Untreated Peripheral T-cell Lymphoma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Junning Cao
- Numéro de téléphone: +86-21-64175590
- E-mail: cao_junning@126.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 1. Subjects fully understand and voluntarily participate in this study and sign informed consent
- 2. Age≥18, ≤70 years
- 3. Histologically confirmed diagnosis of treatment-naïve PTCL, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL, ALK+ALCL with IPI≥2, no limitation with ALC-ALCL), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma, hepatosplenic T-cell, γ/δ T-cell lymphoma; Other PTCL that investigators consider to be appropriate to be enrolled.
- 4. No previous systemic treatment before enrollment.
- 5. At least one measurable lesions according to LUGANO 2014 criteria.
- 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- 7. Life expectancy ≥3 months.
- 8. Ineligible or decline to receive autologous stem cell transplantation (ASCT).
- 9. Adequate main organ function defined as the following required baseline laboratory data: Absolute neutrophil count (ANC)≥1.5×109/L without given G-CSF within 14 days; Platelet count (PLT)≥75×109/L without given transfusion with 14 days; Hemoglobin (HB)≥8g/dL without given transfusion or erythropoietin; Total bilirubin (TBIL)≤1.5X upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5X ULN; Serum creatinine (Scr)≤1.5X ULN; Left ventricular ejection fraction (LVEF)≥50%; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age was defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
- 10.If there is a risk of pregnancy, all participants (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% for entire treatment period up to 120 days after the last dose of investigational drug (or 180 days after chemotherapeutic drug).
Exclusion Criteria:
- 1. Current or previous history of other malignancies within 5 years prior to study enrollment.
- 2. Current diagnosis of any of the following: Adult T-cell leukemia/lymphoma, precursor cell lymphoblastic leukemia/lymphoma, extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), indolent cutaneous T-cell lymphoma (CTCL).
- 3. Target lesions were treated with radiotherapy within 4 weeks of enrollment.
- 4. Patients undergo interventional clinical trials.
- 5. Concurrent lymphoma with CNS invasion.
- 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- 7. Known allergy to the active ingredients or excipients of IBI376 and CHOP regimens.
- 8. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- 9. Positive test results for HBsAg antigen and HBV-DNA, or hepatitis C virus (HCV) antibody.
- 10. Received live vaccine within 30 days prior to initial investigational drug administration (day 1 of cycle 1) (Note: inactivated virus vaccine for injection is allowed within 30 days prior to initial administration, but live attenuated vaccine is not allowed).
- 11. Pregnant or breastfeeding women.
- 12. Any serious uncontrolled systemic disease.
- 13. Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: PI3Kδ inhibitor Parsaclisib plus CHOP
Phase Ib (Explored the appropriate dose of Parsaclisib in combination with CHOP) Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. CHOP was given at the standard dose, 21 days per cycle Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib day 1-14 of each cycle, as well as CHOP at standard dose for 6 cycles. Maintain treatment: Parsaclisib maintenance (2.5mg po, qd) will be performed on CR or PR patients after 6 cycles of induction therapy until disease progression, death, unacceptable toxicity, withdrawal of informed consent, or the investigator's decision or initiation of new antitumor therapy. The maximum maintenance period of parsaclisib is 24 months. |
Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib. Maintain treatment: 2.5mg orally every day continuously, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years.
Autres noms:
Cyclophosphamide: 750mg/m2, IV, d1 Doxorubicin: 50mg/m2, IV, d1 Vincristine: 1.4mg/m2, IV, d1 (maximum 2mg) Prednison: 100mg, po, d1-5 21 days per cycle
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
3-year EFS
Délai: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
|
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
|
From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Toxicité hématologique et non hématologique
Délai: Tout au long de la période de traitement, jusqu'à 6 mois
|
nombre de participants présentant des événements indésirables liés au traitement, tel qu'évalué par CTCAE v5.0
|
Tout au long de la période de traitement, jusqu'à 6 mois
|
CRR
Délai: at the end of Cycle 6 (each cycle is 21 days)
|
the ratio of numbers of patients with complete response to all the participants receiving treatment
|
at the end of Cycle 6 (each cycle is 21 days)
|
ORR
Délai: at the end of Cycle 6 (each cycle is 21 days)
|
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
|
at the end of Cycle 6 (each cycle is 21 days)
|
EFS
Délai: From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
|
the period from the date of patients sign informed consent to the observed event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment
|
From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
|
OS
Délai: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
|
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
|
From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Junning Cao, Fudan University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antirhumatismaux
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Antibiotiques, Antinéoplasiques
- Cyclophosphamide
- Doxorubicine
- Vincristine
Autres numéros d'identification d'étude
- PTCL-2022-01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur PTCL
-
Prescient Therapeutics, Ltd.RecrutementCancer avancé | PTCLAustralie
-
The First Affiliated Hospital with Nanjing Medical...Recrutement
-
University of VirginiaCelgeneRecrutement
-
Anne Beaven, MDBoehringer Ingelheim; National Comprehensive Cancer NetworkRetiré
-
Shandong Provincial HospitalInconnueGemcitabine | PTCLChine
-
Shanghai YingLi Pharmaceutical Co. Ltd.Pas encore de recrutement
-
The First Hospital of Jilin UniversityRecrutementPatients atteints de PTCL qui ont obtenu une réponse complète après un traitement de première intentionChine
-
University of VirginiaMerck Sharp & Dohme LLC; Otsuka Pharmaceutical Development & Commercialization...RecrutementCTLC | PTCLÉtats-Unis
-
Fondazione Italiana Linfomi - ETSActif, ne recrute pasLymphomes périphériques à cellules T (PTCL) | PTCL-NOS | Lymphome à cellules T angio-immunoblastique (AITL) | ALK - Lymphome anaplasique à grandes cellules (LAGC) | Lymphome T périphérique nodal d'origine des cellules auxiliaires folliculaires TItalie
-
Royal Marsden NHS Foundation TrustInconnue
Essais cliniques sur Parsaclisib
-
Incyte CorporationComplétéAnémie hémolytique auto-immuneÉtats-Unis, France, Italie, L'Autriche
-
Incyte CorporationActif, ne recrute pasLymphomeBelgique, États-Unis, France, Israël, Italie, Royaume-Uni, Allemagne, Espagne, Pologne, Australie, Argentine, Danemark
-
Incyte CorporationActif, ne recrute pasLymphomeÉtats-Unis, Espagne, Italie, Israël, Pologne, Royaume-Uni, Canada, Tchéquie, Allemagne, Danemark, Australie, Hongrie, Suède
-
Incyte CorporationComplété
-
Incyte CorporationComplété
-
UNC Lineberger Comprehensive Cancer CenterIncyte CorporationRetiréCancer du sein | Tumeurs mammaires | Cancer du sein triple négatif | Cancer du sein HER2 positif
-
Incyte Biosciences Japan GKComplété
-
Innovent Biologics (Suzhou) Co. Ltd.Actif, ne recrute pasLymphome non hodgkinien indolentChine
-
Incyte CorporationComplété
-
Incyte CorporationComplétéSyndrome de Sjögren primaireÉtats-Unis