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A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) - INCB50465-203

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell NHL (follicular lymphoma) Grade 1, 2, and 3a.
- Ineligible for hematopoietic stem cell transplant.
- Must have been treated with at least 2 prior systemic therapies.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
- Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Criteri di esclusione: 

- Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
- History of central nervous system lymphoma (either primary or metastatic).
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
- Active graft-versus-host disease.
- Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Schema di trattamento: 

Group A
INCB050465 once daily (QD) for 8 weeks followed by INCB050465 once weekly

Group B
INCB050465 QD

Trattamento sperimentale: 

INCB050465

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Objective response rate with INCB050465 based on Lugano classification response criteria [ Time Frame: Weeks 8, 16, and 24, then every 12 weeks through Week 96, and then every 24 Weeks thereafter until disease progression, up to approximately 12 months. ]
    Defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by an independent review committee.

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

Riferimento: Prof. Pier Luigi Zinzani
Telefono: 0512143680
Email: pierluigi.zinzani@unibo.it

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

 

A.O.U. “ Maggiore della Carità”
Corso Mazzini 18 - 28100 Novara - NO

Email: ematologia.dir@maggioreosp.novara.it

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

 

Ospedale di Vicenza
Viale Rodolfi 37 - 36100 Vicenza - VI

Email: segr.ematologia@aulss8.veneto.it

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

 

IRCCS Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini 1 - 71013 San Giovanni Rotondo - FG

Email: ematologia@operapadrepio.it

 

Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini 5 - 80131 Napoli - NA

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

 

AO “V. Cervello”
Via Trabucco 180 - 90146 Palermo - PA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03126019

Data di inserimento: 26.03.2019

Promotore

Incyte Corporation

CRO

/

Principal Investigator ITALIA

Ospedale Sant'Orsola Malpighi, Bologna

Riferimento: Prof. Pier Luigi Zinzani

Telefono: 0512143680

Email: pierluigi.zinzani@unibo.it

Localita: Bologna

 

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