A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab,or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

TX218048
  • Ages 18-100
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and tolerability of INCB050465 when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

  • Adequate hematologic, hepatic, and renal function.

  • Willingness to avoid pregnancy or fathering a child.

  • Ability to comprehend and willingness to sign an ICF

Exclusion

Exclusion Criteria:**

  • 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.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Connect with a study center

  • AZIENDA OSPEDALIERA SAN GERARDO DI MONZA

    MONZA, 20835
    Italy

    Active - Recruiting

  • OSPEDALE DELLE CROCI - EMATOLOGIA RAVENNA

    RAVENNA, 48121
    Italy

    Active - Recruiting

  • Hospital General Universitari Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • HOSPITAL CLINICO UNIVERSITARIO DE SALAMANCA

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • HOSPITAL UNIVERSITARI Y POLITECNIC LA FE

    Valencia, Valencia 46026
    Spain

    Active - Recruiting

  • UNIVERSITY OF ARIZONA CANCER CENTER - OUT PT.

    TUCSON, Arizona 85719
    United States

    Active - Recruiting

  • INDIANA BLOOD AND MARROW TRANSPLANTATION

    INDIANAPOLIS, Indiana 46237
    United States

    Active - Recruiting

  • TEXAS ONCOLOGY

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Baylor Charles A. Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • BAYLOR COLLEGE OF MEDICINE

    HOUSTON, Texas 77030
    United States

    Active - Recruiting

  • SMITH CLINIC

    HOUSTON, Texas 77054
    United States

    Active - Recruiting

  • CANCER CARE CENTERS OF SOUTH TEXAS

    SAN ANTONIO, Texas 78217
    United States

    Active - Recruiting

  • Texas Oncology - San Antonio

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • HOSPITAL GERMANS TRIAS I PUJOL

    BADALONA, 08916

    Active - Recruiting

  • ASST SPEDALI CIVILI DI BRESCIA

    BRESCIA, 25123

    Active - Recruiting

  • FUNDACION JIMENEZ DIAZ UNIVERSITY HOSPITAL

    MADRID, 28040

    Active - Recruiting

  • HOSPITAL UNIVERSITARIO HM SANCHINARRO

    MADRID, 28050

    Active - Recruiting

  • AZIENDA OSPEDALIERA UNIVERSITARIA PISANA

    PISA, 56126

    Active - Recruiting

  • HOSPITAL CLINIC DE BARCELONA

    BARCELONA, BARCELONA 08036

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, Sevilla 41013

    Active - Recruiting

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