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Closed (no longer recruiting)Last updated: 25 January 2024

CITADEL-202: This phase II trial is testing an investigational drug (INCB050465) in patients with Diffuse Large B-Cell Lymphoma that has got worse or is not responsive to treatmentA Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Clinical summary

Summary

The purpose of this study is to assess the safety and efficacy of INCB050465 in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Conditions

This trial is treating patients with Diffuse Large B-Cell Lymphoma (DLBCL).

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

CITADEL-202

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Incyte Corporation

Scientific Title

A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Eligibility

Inclusion

  • Eligible 19 years and older in South Korea
  • Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
  • Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
  • Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
  • Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion

  • Primary mediastinal (thymic) large B-cell lymphoma.
  • Known brain or central nervous system metastases or history of uncontrolled seizures.
  • Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
  • Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
  • Prior treatment with the following:

    • Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
    • Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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