ServiziMenu principale

<< Torna a "Studi Fase I"

A Phase 1, Open-Label, Dose-Finding Study of Parsaclisib in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma - INCB50465-112 (CITADEL-112)

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I,

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Men and women, aged 18 years or older on the day of signing the Informed Consent Form (ICF).
- Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.
- Participants with DLBCL, MZL or MCL must have received at least 1 prior line of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
- Participants with FL must have received at least 2 prior lines of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
- Ineligible for stem cell transplant.
- Participants with DLBCL must have failed or refused stem cell transplantation or failed first-line salvage therapy if ineligible for transplantation.
- Must be willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
- Life expectancy of > 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 (see Appendix D).
- Willingness to avoid pregnancy or fathering a child.
- Ability to comprehend and willingness to sign an ICF

Criteri di esclusione: 

- Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
- Histologically confirmed rare non-Hodgkin B-cell subtypes.
- History of or central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- For participants to be treated with bendamustine (Treatment B), prior treatment with bendamustine (within 12 months of the start of study treatment). Participants with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria:
    - Did not discontinue because of tolerability concerns.
    - Achieved either partial response (PR) or complete response (CR) to the bendamustine regimen of at least 12 months in duration before relapse/progression.
    - Experienced progression following a regimen containing an alkylating agent.
- For participants to be treated with ibrutinib (Treatment C), prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
- Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- Active graft-versus-host disease following allogeneic transplant.
- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Trattamento sperimentale: 

Treatment A: INCB050465 + Rituximab
Treatment B: INCB050465 + Bendamustine + Rituximab
Treatment C: INCB050465 + Ibrutinib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 12 months. ]
A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Obiettivi secondari dello studio: 

- Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]
Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.

- Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]
Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.

Centri partecipanti

Nord Italia

Azienda Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

Riferimento: Dr.ssa Alessandra Tucci
Email: alessandra.tucci@asst-spedalicivili.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Dr. Gambacorti Passerini
Telefono: 0392333435
Email: info_ematologia@asst-monza.it

 

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA

Riferimento: Dr.ssa Monica Tani
Email: monica.tani@auslromagna.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03424122

Data di inserimento: 21.03.2019

Promotore

CRO

NA

Principal Investigator ITALIA

Ospedale San Gerardo, Monza

Riferimento: Dr. Carlo Gambacorti Passerini

Telefono: 0392333435

Email: info_ematologia@asst-monza.it

Localita: Monza

 

<< Torna a "Studi Fase I"